KANDUNGAN CONTENT · telah berjaya mendapat akreditasi penuh untuk MS ISO / IEC 17025 oleh Jabatan...

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Biro Pengawalan Farmaseutikal KebangsaanNational Pharmaceutical Control Bureau

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1. Visi, Misi, Matlamat & Strategi | Vision, Mission, Objectives & Strategy

2. Perutusan Pengarah | Director’s Foreword Message

3. Pengurusan Tertinggi BPFK | NPCB’s Top Management

4. Sidang Pengarang | Editorial Board

5. BPFK | NPCB

6. Carta Organisasi | Organisational Chart

7. Piagam Pelanggan | Client’s Charter

8. Senarai Perjawatan | List of Posts

9. Jasamu Dikenang | Remembering Your Services

10. Anugerah Perkhidmatan Cemerlang | Excellent Service Awards

11. Pusat Pendaftaran Produk | Centre for Product Registration

12. Pusat Kawalan Kualiti | Centre for Quality Control

13. Pusat Pasca Pendaftaran Produk | Centre for Post Registration of Products

14. Pusat Komplians dan Pelesenan | Centre for Compliance and Licensing

15. Pusat Pembangunan Organisasi | Centre for Organisational Development

16. Pusat Pentadbiran | Centre for Administration

17. Galeri | Gallery

18. Aktiviti Sosial | Social Activities

19. Penyertaan Dalam Aktiviti Antarabangsa & Tempatan | Participation in International & Local Events

20. Pelawat Antarabangsa & Tempatan | International & Local Visitors

KANDUNGANCONTENT

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VISIBiro Pengawalan Farmaseutikal Kebangsaan sebagai pusat kecemerlangan unggul dalam bidang regulatori farmaseutikal demi menjamin kesihatan dan kesejahteraan insan sejagat

MISIBiro Pengawalan Farmaseutikal Kebangsaan akan memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui pelaksanaan undang-undang oleh tenaga kerja yang berketerampilan dan usahasama strategik ke arah peningkatan status kesihatan rakyat

MATLAMATMemastikan bahawa bahan-bahan terapeutik yang dibenarkan di pasaran tempatan adalah selamat, berkesan dan berkualiti, serta menentukan bahawa produk semulajadi (tradisional) dan kosmetik yang dibenarkan di pasaran adalah selamat dan berkualiti

STRATEGIMemastikan kecekapan dan keberkesanan organisasi melalui pemodenan dan automasi sistem-

sistem pejabat, makmal dan pendaftaran, peninjauan serta penambahbaikan perkhidmatan secara berterusan

Memperkukuh aktiviti penguatkuasaan undang-undang berkaitanMemastikan suasana kefahaman dua hala dan kerjasama berterusan sentiasa wujud antara pihak

regulatori dengan sektor swasta melalui sesi dialog dan bimbinganMeningkatkan potensi serta kepakaran warga kerjaMewujudkan satu kumpulan tenaga kerja yang berdedikasi dan penuh komitmen melalui motivasi,

penghargaan serta ganjaran yang berpatutanMempergiatkan aktiviti penyelidikan serta meningkatkan kemudahan-kemudahan bagi tujuan

tersebutMewujudkan satu suasana yang menggalakkan kerja secara berpasukan dengan sikap penyayang,

serta melaksanakan tugas-tugas secara profesional

VISI & MISI VISION & MISSION

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VISIONThe National Pharmaceutical Control Bureau will be a centre of excellence on pharmaceutical regulatory matters to ensure the health and well-being of mankind

MISSIONThe National Pharmaceutical Control Bureau shall ensure the quality, efficacy and safety of pharmaceutical products through the implementation of relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the people

OBJECTIVETo ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that natural (traditional) products and cosmetics approved are safe and of quality

STRATEGIESTo ensure organisational efficiency and effectiveness through modernisation and automation of the

office, laboratory and registration systems, with regular review and improvement of servicesTo strengthen enforcement activity of the related legislationsTo ensure continuous mutual understanding and co-operation between the regulatory bodies and the

private sector through dialogues and guidanceTo upgrade personnel potential and expertiseTo attain a dedicated and fully committed workforce through motivation, appreciation, and

appropriate remunerationTo strengthen research activities and upgrade facilities for such purposesTo create working environment conducive for the personnel to work as a team with a caring attitude

whilst discharging their duties in a professional manner

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Laporan tahunan Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) 2010 yang mengambil kira semua aktiviti dan usaha yang dilaksanakan sepanjang tahun 2010, tanpa mengenepikan cabaran-cabaran yang bakal dihadapi pada tahun 2011, membuktikan sekali lagi akan keperluan agensi-agensi regulatori ubat seperti BPFK untuk sentiasa mengamalkan pendekatan yang inovatif dan menerokai paradigma baru bagi menghadapi cabaran dalam arena regulatori ubat pada masa akan datang. Laporan ini memberi gambaran yang komprehensif berkaitan pencapaian utama serta aktiviti-aktiviti penting yang dijalankan oleh anggota agensi ini sepanjang tahun dalam usaha mencapai mandat dan teras yang terkandung dalam misi BPFK; menjalin hubungan strategik dengan pihak-pihak berkenaan serta berusaha ke arah memelihara dan memperbaiki tahap kesihatan rakyat dengan memastikan produk farmaseutikal yang dipasarkan di negara ini adalah selamat, berkesan dan berkualiti. Oleh itu, saya, bagi pihak BPFK dengan berbesar hatinya sekali lagi mempersembahkan kepada anda, Laporan Tahunan BPFK 2010.

Tahun 2010 sememangnya merupakan tahun yang penuh peristiwa bagi BPFK. Yang Berhormat Menteri Kesihatan Malaysia, Y.B. Dato’ Sri Liow Tiong Lai telah melawat organisasi ini dan menyaksikan sendiri pelbagai aktiviti serta fungsi yang dijalankan oleh setiap pusat di organisasi ini. BPFK juga telah menjadi tuan rumah kepada beberapa acara regulatori yang penting di peringkat serantau dan antarabangsa serta pelbagai seminar dan sesi latihan yang dijalankan dalam negara sepanjang tahun. Malaysia telah dipilih sebagai tuan rumah oleh Pharmaceutical Inspection Cooperation Scheme (PIC/S) yang berpangkalan di Eropah untuk menganjurkan Mesyuarat Agung Tahunan serta seminar yang berkaitan dengan produk perubatan tradisional / herba. Acara berprestij ini telah dihadiri oleh wakil-wakil dari 36 negara termasuk negara-negara anggota PIC/S dan juga negara-negara bukan anggota dari rantau ASEAN. Di samping itu, Mesyuarat Bersama Antimalarial Fixed Dose Combination of Artesunate-Mefloquine bagi rantau ASEAN yang telah diadakan di Kuala Lumpur merupakan satu lagi wadah di mana delegasi dari pelbagai negara dapat bersatu-padu dan berkerjasama dalam membentuk dasar-dasar yang seragam mengenai isu-isu regulatori yang akan memastikan kebolehcapaian ubat untuk penyakit-penyakit yang terabai.

Agensi-agensi regulatori farmaseutikal, seperti badan-badan regulatori yang lain seharusnya bergantung kepada input serta penemuan saintifik dan teknologi untuk kekal dinamik dan relevan. Bagi tujuan ini, BPFK telah memulakan kajian semula ke atas Garis Panduan Pendaftaran Ubat sedia ada untuk menghasilkan dokumen

The National Pharmaceutical Control Bureau (NPCB) annual report 2010 which takes stock of the events and efforts of 2010, while looking ahead to the challenges of 2011, underscores once again the need for drug regulatory agencies like NPCB to constantly inject innovative approaches and explore new paradigms in order to meet the complexities and challenges in the drug regulatory arena in the coming years. This report strives to provide a comprehensive view of the key milestones achieved by the agency and important activities undertaken by its staff throughout the year in pursuance of accomplishing its mandate, the thrust of which is embodied in its mission statement; forging strategic alliance with its stakeholders and working towards safeguarding and improving the health of the nation by ensuring pharmaceutical products marketed in the country are safe, efficacious and of quality. Thus it is with pleasure that I present to you once again, on behalf of the NPCB, the Annual Report for 2010.

The year 2010 was indeed an eventful year for the NPCB. The Honourable Minister of Health Malaysia, Y.B. Dato’ Sri Liow Tiong Lai paid a visit to the organisation and witnessed firsthand the workings of various departments under the jurisdiction of the organisation. NPCB also played host to a number of important regulatory events both international and regional, in addition to numerous seminars and training sessions conducted locally throughout the year. Malaysia was chosen as the venue by the Europe based Pharmaceutical Inspection Cooperation Scheme (PIC/S) for its Annual General Meeting and its related seminar on traditional / herbal medicine products. This prestigious event was attended by representatives from some 36 countries including member countries of PIC/S and also non-member countries from the ASEAN region. Additionally, a Joint Meeting on Antimalarial Fixed Dose Combination of Artesunate-Mefloquine for the ASEAN region held in Kuala Lumpur was another occasion where countries came together to forge harmonised policies on regulatory matters that will ensure expeditious access to medicines used for neglected diseases.

Pharmaceutical regulatory agencies, like any other regulatory bodies inevitably must rely on scientific and technological inputs and breakthroughs to maintain their dynamism and relevance. Towards this end, NPCB has embarked on a major review of the existing Drug Registration Guideline which on completion will see a more user friendly document that defines policies in an unequivocal manner and incorporate changes that are updated and in line with evolving international standards. Another milestone in its achievement is the promulgation of guidelines for the registration of homeopathic products, the result years of work and in collaboration with the Malaysian Homeopathic Medical Council. The department’s client’s charter too has undergone some significant changes with the focus on reduced timeline for registration and licensing activities, the result of efforts to reengineer some of the processes and

Perutusan Pengarah Director’s Foreword Message

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yang lebih mesra pengguna dan memperjelaskan dasar serta menggariskan beberapa perubahan selaras dengan piawaian antarabangsa yang terkini. Selain itu, antara pencapaian lain BPFK adalah pelancaran garis panduan bagi pendaftaran produk homeopati yang merupakan hasil usahasama dengan Majlis Perubatan Homeopati Malaysia. Piagam pelanggan organisasi ini juga telah melalui perubahan yang ketara dengan memfokuskan kepada pengurangan tempoh masa bagi aktiviti pendaftaran dan pelesenan, hasil daripada usaha-usaha untuk mengubahsuai beberapa proses dan prosedur yang terlibat serta perubahan dalaman BPFK.

Dari sudut inisiatif kualiti pula, selain daripada mengekalkan Sistem Pengurusan Kualiti MS ISO 9001:2008, BPFK juga telah berjaya mendapat akreditasi penuh untuk MS ISO / IEC 17025 oleh Jabatan Standard Malaysia di bawah Skim Makmal Malaysia. Pusat Kawalan Kualiti, BPFK sedang berusaha untuk memperluaskan lagi skop akreditasi bagi meliputi pelbagai ujian kimia dan mikrobiologi.

Di atas kesedaran akan komitmen dan tanggungjawabnya terhadap rakan-rakan serantau dan antarabangsa, BPFK sentiasa menjalinkan perhubungan positif untuk terus memupuk kerjasama dan berkolaborasi dalam aspek-aspek regulatori. Sebagai Pusat Kolaborasi Pertubuhan Kesihatan Sedunia (WHO) bagi kawalan regulatori farmaseutikal sejak tahun 1996, BPFK terus memainkan peranan yang penting dalam mempertingkatkan kapasiti anggota regulatori dari negara-negara anggota WHO melalui latihan-latihan yang dijalankan. Organisasi ini juga sedang berusaha ke arah menjadi ahli bukan OECD yang mematuhi Sistem Mutual Acceptance Data (MAD) di bawah Amalan Makmal Baik (GLP) OECD. Pematuhan ini dijangka akan memberi kesan yang mendalam kepada industri farmaseutikal dan bioteknologi yang menjalankan kajian bukan klinikal di negara ini. Di peringkat ASEAN, BPFK memainkan peranan yang amat aktif dalam mesyuarat-mesyuarat ASEAN melalui penglibatan dalam pelbagai kumpulan kerja yang berkaitan.

Kesimpulannya, saya ingin mengambil kesempatan ini untuk mengucapkan terima kasih kepada semua anggota BPFK atas dedikasi dan usaha mereka yang berterusan dalam memberikan perkhidmatan yang berkualiti kepada semua pihak yang terlibat. Semua kejayaan dan pencapaian ini tidak mungkin tercapai tanpa kerja berpasukan serta penghargaan yang mendalam terhadap cabaran-cabaran yang dihadapi dalam arena regulatori.

procedures involved coupled with some important changes within the department itself.

Among the quality initiatives, apart from maintaining its quality management system MS ISO 9001:2008, the organisation also successfully underwent full accreditation for MS ISO / IEC 17025 by the Department of Standards Malaysia under the Malaysian Laboratory Scheme. The Centre for Quality Control is currently working on extending the accredited tests to cover a broader range of chemical and microbiological testings.

The NPCB, aware of its commitments and obligations to its international and regional partners, continues to engage them positively to foster cooperation and collaboration in regulatory matters. As a World Health Organisation Collaborating Centre for regulatory control of pharmaceuticals since 1996, NPCB has continued to play an important role in the capacity building of the regulatory staff of WHO member countries as it benefits from the interactions with these countries. The organisation is also working towards becoming a non-OECD member complying with the Mutual Acceptance Data System of OECD Good Laboratory Practice, the adherence to which is expected to have far reaching effects to pharmaceutical and biotechnology industry conducting non clinical studies in the country. Regionally, NPCB plays a very active role in ASEAN meetings by way of its involvement in the various product working groups.

To conclude, I would like take this opportunity to thank the NPCB staff for their tireless effort and dedication in continuing to provide quality service to all the stakeholders. Many of the accomplishments and achievements would not have been possible without the collective teamwork and a deep sense of appreciation of the challenges that lines the regulatory arena.

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Kiri ke KananLeft to Right

Timbalan Pengarah Pusat Pendaftaran Produk Deputy Director of Centre for Product Registration

Mdm. Siti Aida Abdullah

Timbalan Pengarah Pusat Komplians dan Pelesenan Deputy Director of Centre for Compliance and Licensing

Mr. Sulaiman Haji Ahmad

Pengarah Regulatori FarmasiDirector of Pharmacy Regulatory

Mr Selvaraja Seerangam

Timbalan Pengarah Pusat Pembangunan Organisasi Deputy Director of Centre for Organisational Development

Mr. Tan Ann Ling

Timbalan Pengarah Pusat Kawalan Kualiti Deputy Director of Centre for Quality Control

Dr. Tajuddin Akasah

Timbalan Pengarah Pusat Pasca Pendaftaran Produk Deputy Director of Centre for Post-Registration of Products

Ms. Sameerah Shaikh Abd. Rahman

Ketua Pusat Pentadbiran Head of Centre for Administration

Mr. Mohd Zaidie Bin Hj. Che Din

PENGURUSAN TERTINGGITOP MANAGEMENT

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DepanFront

BelakangBack

Tidak HadirAbsent

• Nadia binti Mohd Izham• Muhammad Mazree b.

Mohamed Mahidin• Wayne Wong Guan Wei• Azri bin Nasruddin• Wo Wee Kee

• Zamzarina Binti Saari• Nor Dalila binti Sabuan• Azlina Ismail• Sim Bee Ai• Lathifah Ahmad Zawawi• Tan Shiau Yi• Woo Ai Ling• Seow Ee Laine• Abdul Halim Bin Zahri

• Asnida Mat Daud• Ng Sheng Xyng• Fadhilah binti Hasbullah• Erina Camilla bt. Mohd Ghazali• Khairul Huda binti

Mohammadiah

Kiri ke KananLeft to Right

SIDANG PENGARAHEDITORIAL BOARD

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Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) merupakan sebuah agensi regulatori kerajaan di Malaysia yang memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal, serta kualiti dan keselamatan produk semulajadi (tradisional) dan kosmetik yang dipasarkan di dalam negara.

Dari segi kepakaran teknikal dan kemampuan, BPFK telah diiktiraf oleh World Health Organisation (WHO) sebagai Pusat Kolaborasi bagi Kawalan regulatori Farmaseutikal pada 10 Mei 1996. Sehubungan dengan itu, BPFK telah menyediakan latihan dalam jaminan kualiti dan hal ehwal regulatori kepada pegawai-pegawai dari agensi regulatori kebangsaan yang lain.

Di samping itu, BPFK telah diterima sebagai ahli ke-26 dalam Pharmaceutical Inspection Co-operation Scheme (PIC/S) pada 1 Januari 2002. Sejak itu, BPFK telah terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa.

Bagi memastikan mutu perkhidmatan yang lebih berkualiti, BPFK telah bekerja keras dalam menaiktarafkan Sistem Pengurusan Kualiti. Pensijilan dari SIRIM, iaitu MS ISO 9001:2000, telah digantikan dengan MS ISO 9001:2008. Selain itu, BPFK telah memperoleh akreditasi MS ISO 17025:2005 bagi Pusat Kawalan Kualiti (PKK) di bawah Skim Akreditasi Makmal Malaysia (SAMM) pada tahun 2010.

The National Pharmaceutical Control Bureau (NPCB) is a government agency that regulates pharmaceutical, natural (traditional) and cosmetic products in Malaysia. The NPCB ensures the quality, efficacy and safety of pharmaceutical products as well as the quality and safety of natural (traditional) products and cosmetics marketed in the country.

In view of its technical expertise and training capabilities, the NPCB was recognised by the World Health Organisation (WHO) as a Collaborating Centre in the Regulatory Control of Pharmaceuticals on the 10th May 1996. As a WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, the NPCB has provided training in the fields of pharmaceutical quality assurance and regulatory affairs to fellows from other National Regulatory Agencies.

In addition, the NPCB successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPCB has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

In order to improve its services quality, the NPCB continues to strive towards upgrading its Quality Management System. As a result, the NPCB has successfully upgraded its MS ISO certification from version MS ISO 9001:2000 to MS ISO 9001:2008. Furthermore, NPCB has obtained MS ISO 17025:2005 accreditation for Centre for Quality Control under the Malaysian Laboratory Accreditation Scheme (SAMM) in 2010.

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN THE NATIONAL PHARMACEUTICAL CONTROL BUREAU

Certi�ed to ISO 9001: 2008Cert. No : AR 2293

WHO Collaborating Centrefor Regulatory Control of

Pharmaceuticals

26th MemberPharmaceutical Inspection

Cooperation Scheme


CARTA ORGANISASIORGANISATION CHART

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CARTA ORGANISASI

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ORGANISATION CHART

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PIAGAM PELANGGAN

1. PENDAFTARAN PRODUK MASAPenilaian Penuh

• Menilai permohonan pendaftaran:o Ubat preskripsi 210 hari bekerja*o Ubat bukan preskripsi 210 hari bekerja*o Ubat baru dan biologikal 245 hari bekerja*

Penilaian Ringkas• Menilai permohonan pendaftaran produk suplemen kesihatan

dan produk semulajadi yang mengandungi:o Bahan aktif tunggal 60 hari bekerja*o 2 atau lebih bahan aktif 80 hari bekerja*

• Pengeluaran notifikasi kosmetik 3 hari bekerja ^• Pertukaran pemegang pendaftaran 45 hari bekerja*• Sijil Perakuan Produk 15 hari bekerja*• Pertukaran Tapak Pengilang 45 hari bekerja*

2. PELESENAN

• Pengeluaran lesen pengilang, pemborong dan pengimport 10 hari bekerja*• Penilaian Permohonan Lesen Import untuk Percubaan Klinikal

dan Kebenaran Mengilang untuk Percubaan Klinikal: o Bagi produk yang melibatkan First-in-Man Study, produk

biologikal dan Advanced Therapy Product (ATP) 45 hari bekerja*o Bagi produk-produk selain daripada yang disebutkan di atas 30 hari bekerja*

3. UJIAN MAKMAL

• Pengujian sampel bagi tujuan pendaftaran 65 hari bekerja#

*Setelah menerima permohonan yang lengkap^Untuk permohonan yang memenuhi keperluan ASEAN Cosmetic Directive (ACD)#Setelah menerima sampel dan dokumentasi yang lengkap

PIAGAM PELANGGAN

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CLIENTS CHARTER

1. PRODUCT REGISTRATION DURATIONFull Evaluation

• To evaluate application for registration of:o Prescription drugs 210 working days*o Non-prescription drugs 210 working days*o New drugs and biologicals 245 working days*

Abridged Evaluation• To evalute application for registration of health

supplements and traditional products containing:o Single active ingredient 60 working days*o 2 or more active ingredients 80 working days*

• Issuance of cosmetic notification 3 working days^• Change of registration holder 45 working days*• Certificate of Pharmaceutical Product (CPP) 15 working days*• Change of manufacturing site 45 working days*

2. LICENSING

• Issuance of manufacturer’s, wholesaler’s and importer’s license 10 working days*• Evaluation of import license application for Clinical Import Trial License (CTIL)

and Clinical TrialExemption (CTX):o For products involving First-in-Man Study, biological products and 45 working days*

Advance Therapy Medicinal Product (ATMP)o For products other than stated above 30 working days*

3. LABORATORY TESTING

• Sample testing for purpose of registration 65 working days#

*Upon receipt of complete application^For applications fulfilling ASEAN Cosmetic Directive (ACD) requirements#Upon receipt of sample and complete documentation

CLIENTS CHARTER

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JAWATANPOSITION

GREDGRADE

BIL JAWATAN NUMBER OF POSITION

PENGISIAN FILLED

KEKOSONGAN VACANCIES

Pengarah (JUSA C)Director (JUSA C) VU7 1 1 0Pegawai FarmasiPharmacist U54 8 8 0Pegawai FarmasiPharmacist U52 17 7 10Pegawai FarmasiPharmacist U48 37 9 28Pegawai FarmasiPharmacist U44 23 21 2Pegawai FarmasiPharmacist U41 153 138 15Pegawai Teknologi Maklumat Information Technology Officer F41 1 1 0Penolong Pegawai FarmasiPharmacist Assistant U36 2 2 0Penolong Pegawai FarmasiPharmacist Assistant U32 8 8 0Penolong Pegawai FarmasiPharmacist Assistant U29 70 69 1Penolong Pegawai Teknologi Maklumat Information Technology Officer Assistant F32 1 1 0Penolong Pegawai TadbirAdministrative Officer Assistant N36 1 1 0Penolong Pegawai PerangkaanStatistical Officer Assistant E27 1 0 1Penolong Pegawai TadbirAdministrative Officer Assistant N27 2 2 0Setiausaha PejabatSecretary Officer N27 3 3 0Pembantu Tadbir (Stor)Administrative Assistant (Store) N22 1 1 0Pembantu TadbirAdministrative Assistant N22 1 1 0Pembantu TadbirAdministrative Assistant N17 16 15 1Pembantu Tadbir (Kewangan)Administrative Assistant (Finance) W22 2 2 0Pembantu Tadbir (Kewangan)Administrative Assistant (Finance) W17 9 9 0Pembantu PerpustakaanLibrary Assistant S17 1 1 0Pegawai Khidmat PelangganCustomer Service Officer N17 2 1 1Juruteknik KomputerComputer Technician FT17/FT22 1 1 0Operator Mesin Prosesan DataData Processing Machine Operator F11 2 0 2Pengawal KeselamatanSecurity Guard KP11 3 3 0Pembantu Tadbir Rendah (Jurutaip)Administrative Assistant (Typist) N11 4 0 4Pembantu Am PejabatOffice General Assistant N4 1 1 0Pembantu Am PejabatOffice General Assistant N1 4 2 2Pembantu Perawatan KesihatanHealth Care Assistant U3 10 10 0Pemandu Kenderaan BermotorDriver R3 5 4 1

JumlahTotal 390 322 68

SENARAI PERJAWATAN 2010LIST OF POST 2010

15


REMEMBERING YOUR SERVICES 2010

In 2010, a total of 33 members were transferred, resigned or retired. NPCB would like to thank them and wish them all the best in their future undertakings. All their services as well as contributions to the NPCB are greatly appreciated and remembered. Those who had been transferred were as follows:

JASAMU DIKENANG TAHUN 2010

Pada tahun 2010, sejumlah 33 orang anggota telah berpindah tempat bertugas samada bertukar ke tempat kerja baru, meletak jawatan (berhenti) dan bersara. Kepada semua anggota yang telah meninggalkan BPFK kami mengucapkan selamat maju jaya. Segala khidmat dan jasa bakti yang telah dicurahkan oleh semua kepada BPFK selama ini amatlah dihargai dan akan dikenang untuk selamanya. Mereka yang terlibat adalah seperti berikut:

NAMANAME

JAWATAN POSITION

GRED GRADE

TEMPAT BERTUKAR PLACE TRANSFERED

Muhammad Lukmani bin IbrahimPegawai Farmasi

PharmacistU54

Bahagian Penguatkuasa FarmasiPharmacy Enforcement

Jaafar bin LassaPegawai Farmasi

PharmacistU54

Bahagian Perubatan Tradisional dan KomplementariTraditional and Complementary Medicine Division

Che Ton binti SaariPegawai Farmasi

PharmacistU48

Bahagian Perubatan Tradisional dan KomplementariTraditional and Complementary Medicine Division

Tg. Mira Darami bt Tg. FatimiPegawai Farmasi

PharmacistU41

Hospital Sultanah Zahirah, TerengganuSultanah Zahirah Hospital, Terengganu

Chew Chun KeatPegawai Farmasi

PharmacistU41

Pusat Kajian Klinikal, Hospital Kuala Lumpur (HKL)

Clinical Research Centre (CRC), Kuala Lumpur General Hospital

Ahmad Zuhri bin Md AliPegawai Farmasi

PharmacistU41

Bahagian Perkhidmatan FarmasiPharmaceutical Services Division

Hazlin binti OthmanPegawai Farmasi

PharmacistU41


Norfahmi bin Mohd YusofPegawai Farmasi

PharmacistU41

Jabatan Kesihatan Negeri Johor (Bahagian Penguatkuasa Farmasi)

Johor State Health Department (Pharmacy Enforcement)

Khalidah binti MaruanPegawai Farmasi

PharmacistU41

Jabatan Kesihatan Negeri Selangor (Klinik Kesihatan Bukit Huda)

Selangor State Health Department (Bukit Kuda Health Clinic)

Elaine Kan Mei YingPegawai Farmasi

PharmacistU41

Hospital Kuala Lumpur (HKL)Kuala Lumpur General Hospital

Mohd Ridzam bin LajisPegawai Farmasi

PharmacistU41

Jabatan Kesihatan Wilayah Persekutuan Labuan (JKWP)Labuan Health Department

Nur Syazana binti AmirPegawai Farmasi

PharmacistU41


Hani binti AbdullahPegawai Farmasi

PharmacistU41


Shahrizal bin SaadPegawai Farmasi

PharmacistU41

Jabatan Kesihatan Wilayah Persekutuan Labuan (JKWP)Labuan Health Department

16



NAMANAME

JAWATAN POSITION

GRED GRADE

TEMPAT BERTUKAR PLACE TRANSFERED

Abdullah bin SallehPegawai Farmasi

PharmacistU41

Jabatan Kesihatan Negeri MelakaMalacca State Health Department

Isma Zairika ZainolPenolong Pegawai Farmasi

Assistant PharmacistU29

PKD KangarKangar District Health Centre

Zuraidah bt. ZainuddinPenolong Pegawai Tadbir

Assistant Administrative OfficerN27

Pejabat Tanah dan Galian SelangorSelangor Land Office

Rosnani bt. UstazPembantu Tadbir

Administrative AssistantN17

Jabatan Kesihatan Negeri JohorJohor State Health Department

Suhariah Mohamad JaniPegawai Khidmat Pelanggan

Customer Service OfficerN17

Pejabat Tanah dan Galian SelangorSelangor Land Office

Fairus bt. Mohamad RazailyPegawai Khidmat Pelanggan

Customer Service OfficerN17

PKD Kuala KangsarKuala Kangsar District Health Centre

Mohd Zharif bin YusofPenolong Pegawai Perangkaan

Assistant Statistical OfficerE27

Jabatan Perangkaan Negeri KelantanKelantan State Statistics Department

Latipah bt. Abdullah

Operator Mesin Pemprosesan Data

Data Processing Machine Operator

F11Kementerian Penerangan, Komunikasi dan Kebudayaan

Ministry of Information, Communication and Culture

Zallie bin Mohd. Shah

Operator Mesin Pemprosesan Data

Data Processing Machine Operator

F11Kementerian Penerangan, Komunikasi dan Kebudayaan

Ministry of Information, Communication and Culture

Siti Zaleha binti JamaliPembantu Perawatan Kesihatan

Health Care AssistantU3

Hospital Kuala Lumpur (HKL)Kuala Lumpur General Hospital

SELAMAT MAJU

Senarai nama anggota BPFK yang telah bersara atau meletak jawatan pada tahun 2010:

Dr. Sulaikah V.K Moideen Pegawai FarmasiPharmacist U54 Bersara

Retired

Bariah bt. Abd. Rani Pegawai FarmasiPharmacist U54 Bersara

Retired

Han Mei Yin Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Nahdia Ariffin Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Slavia Fifi Koh Yin Ying Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Rosalind Chong Hui Ee Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Hoo Kiew Hoon Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Lian Lay Kim Pegawai FarmasiPharmacist U41 Berhenti

Resigned

Yip Yi Hui Pegawai FarmasiPharmacist U41 Berhenti

Resigned

ALL THE BEST

The list of NPCB staff who retired or resigned in 2010:

17


ANUGERAH PERKHIDMATAN CEMERLANG

NamaName

JawatanPost

Mazli Bt. Muhammad Pegawai Farmasi U54Pharmacist U54

Zuraida bt. Abdullah Pegawai Farmasi U52Pharmacist U52

Nor Hayati Bt. Abdul Rahim Pegawai Farmasi U48Pharmacist U48

Zarina Bt. Rosli Pegawai Farmasi U48Pharmacist U48

Azura Bt. Abdullah Pegawai Farmasi U48Pharmacist U48

Ida Syazrina Bt. Ibrahim Pegawai Farmasi U48Pharmacist U48

Salasiah Bt. Abdullah Pegawai Farmasi U44Pharmacist U44

Yusni Rizal Bin Khairul Anuar Pegawai Farmasi U44Pharmacist U44

Mazlifah Bt. Mohd. Fahimi Pegawai Farmasi U44Pharmacist U44

Tee Khim Boon Pegawai Farmasi U44Pharmacist U44

Fazillahnor Bt. Ab. Rahim Pegawai Farmasi U44Pharmacist U44

Chua Hui Ming Pegawai Farmasi U44Pharmacist U44

Chai Che Leong Pegawai Farmasi U41Pharmacist U41

Soon Vi Vian Pegawai Farmasi U41Pharmacist U41

Talip Bin Tawil Pen. Pegawai Farmasi U36Pharmacist Assistant

Nischal A/L Gunaseelan Pen. Pegawai Farmasi U29Pharmacist Assistant

Rohaiza Bt. Zainun Pen. Pegawai Farmasi U29Pharmacist Assistant

Yuzaida Bt. Mohd. Yusof Pen. Pegawai Farmasi U29Pharmacist Assistant

Nor Hanani Binti Lamri Pen. Pegawai Farmasi U29Pharmacist Assistant

Siti Hajar Bt. Zahari Pen. Pegawai Farmasi U29Pharmacist Assistant

Junainah Bt. Mohd. Omar Pen. Pegawai Tadbir N27Administrative Assistant N27

Azwana Bt. Asri Pembantu Tadbir (P/O) N17Administrative Assistant N17

Noor Ain Bt. Ahmad Isa Pembantu Tadbir (Kew) W17Administrative Assistant W17

Azizul Bin Naharodzzman Pembantu Perawatan Kes. U3Healthcare Assistant U3

Nur Ridzma Bt. Ridzuan Pembantu Am Pejabat N1Office Assistant N1

EXCELLENT SERVICE AWARDS


PUSAT PENDAFTARAN PRODUKCENTRE FOR PRODUCT REGISTRATION


20



1.0 PENGENALAN

Pusat Pendaftaran Produk berfungsi untuk menguruskan semua proses yang berkaitan dengan pendaftaran produk, iaitu produk dalam kategori ubat baru (NCE), bioteknologi, preskripsi, bukan preskripsi, suplemen kesihatan, produk semulajadi (tradisional) dan veterinar.

Pendaftaran produk dijalankan menerusi sistem atas talian QUEST 3 yang boleh digunakan pada bila-bila masa. Sistem QUEST 3 ini adalah penambahbaikan kepada sistem QUEST 2 dari segi proses kerja penilaian produk. Disamping mengekalkan modul-modul yang sedia ada, beberapa modul baru diperkenalkan dalam sistem QUEST 3 ini bagi memudahkan lagi proses kerja berkaitan pendaftaran produk, antaranya Modul Pengkelasan Produk, Modul Penyemakan Status Produk Untuk Tujuan Penguatkuasaan dan Modul Penilaian Bahan Aktif Farmaseutikal. Bagi memastikan satu sistem yang terbaik dapat dihasilkan untuk kemudahan semua pihak, usaha penambahbaikan ini akan terus dilakukan.

2.0 OBJEKTIF

Objektif pusat ini adalah untuk memastikan semua produk farmaseutikal yang didaftarkan oleh PBKD dinilai dari aspek keselamatan, efikasi dan kualiti manakala ubat semulajadi (tradisional) dinilai dari aspek keselamatan dan kualiti. Pusat ini juga bertanggungjawab dalam memberi bantuan administratif dan teknikal kepada pihak industri yang terlibat dalam urusan pendaftaran produk.

3.0 AKTIVITI-AKTIVITI LAIN

Selain bertanggungjawab ke atas pendaftaran produk, pusat ini juga menjalankan beberapa aktiviti lain seperti berikut:

• Mengeluarkan Sijil Produk Farmaseutikal sebagai kebenaran untuk eksport

• Menguruskan pertukaran Pemegang Pendaftaran Produk

• Menguruskan pembaharuan Sijil Perakuan Pendaftaran Produk

1.0 INTRODUCTION

The Centre for Product Registration is responsible for all processes pertaining to product registration. Products that require registration are classified under one of the following categories: New Chemical Entities (NCE), Biotechnology, prescription, non-prescription, health supplement, natural (traditional) or veterinary products. Product registration is done online through a registration system known as QUEST 3 which is available to the applicants at any time. QUEST 3 is an upgraded version of the previously used QUEST 2 system. Besides maintaining the existing modules, several new modules have been introduced in order to improve and further enhance the registration processes. The module on product classification, modules pertaining to enforcement activities and the Active Pharmaceutical Ingredients (API) evaluation module are among the new modules. This system is continuously being upgraded in order to facilitate product registration for the ease of the user.

2.0 OBJECTIVES

The primary objective of this centre is to ensure that pharmaceutical products are evaluated for its safety, efficacy and quality whereas natural (traditional) products are evaluated for its safety and quality features prior to being registered by the Drug Control Authority. This centre also provides administrative and technical assistance to various stakeholders in matters pertaining to product registration.

3.0 OTHER ACTIVITIES

Besides handling product registration, this Centre also provides several other services such as:

• Issuing the Certificate of Pharmaceutical Product (CPP) for export purposes

• Authorizing changes made to the Marketing Authorization Holder

• Renewal of the Product Registration Certificate

PUSAT PENDAFTARAN PRODUKCENTRE FOR PRODUCT REGISTRATION

21


• Bekerjasama dengan Cawangan Penguatkuasa Farmasi untuk pengesahan status pendaftaran produk yang disyaki melanggar peraturan pendaftaran.

4.0 PENCAPAIAN

Permohonan Diterima

Secara umumnya, Rajah 1 menunjukkan penurunan bagi bilangan penerimaan permohonan pendaftaran produk dari tahun 2006 hingga tahun 2010. Penurunan yang paling ketara dapat dilihat pada tahun 2010, iaitu 55.3% berbanding dengan tahun sebelumnya. Ini adalah kerana pada tahun 2010, Sistem QUEST 3 telah bermula dan hanya permohonan yang lengkap dan melepasi proses saringan penilaian akan diterima untuk penilaian lanjut. Diantara perkara yang disemak semasa proses saringan dijalankan ialah memastikan tiada bahan terlarang dalam formulasi produk, lesen pengilang yang sah, Sijil Jualan Bebas yang sah dan sebagainya.

Jumlah kumulatif penerimaan permohonan sehingga 2010 adalah sebanyak 70,819 permohonan termasuk produk veterinar. Bagi produk veterinar, pendaftaran dan pelesenan produk hanya bermula pada Ogos 2007. Sehingga 2010, jumlah permohonan bagi produk veterinar adalah sebanyak 2,806 dimana bilangan penerimaan permohonan pada 2010 adalah sebanyak 312 permohonan.

Produk Didaftarkan

Penurunan bilangan produk yang didaftarkan adalah berkadar langsung dengan bilangan permohonan yang diterima. Rajah 2 menunjukkan bahawa tiada perbezaan yang ketara dalam jumlah pendaftaran produk preskripsi dan bukan preskripsi pada tahun 2006 hingga 2010. Walaubagaimanapun, bagi produk semulajadi, perbezaan dalam bilangan permohonan yang diterima telah menyebabkan perbezaan yang ketara dalam jumlah produk yang didaftarkan. Pada tahun 2010, sebanyak 54 produk veterinary telah mula didaftarkan. Jumlah kumulatif untuk pendaftaran produk sehingga 2010 adalah sebanyak 43,814 produk (Rajah 2).

• Verifying requests made by the Pharmacy Enforcement Division regarding the registration status of products that are suspected of violating the law

4.0 ACHIEVEMENTS

Applications Received

There was a decline in the number of applications received from 2006 to 2010 for product registration (as in Figure 1). The most significant decline can be observed in 2010 with a reduction of 55.3% as compared to the previous year. This decline could be attributed to the QUEST 3 system whereby only applications approved through the initial screening process could proceed for further evaluation. This screening process mainly verifies that there is no banned ingredient in the formulation, the manufacturer has a valid manufacturing licence and a valid certificate of free sale where applicable.

The cumulative number of applications received was 70,819 including those applications received for the registration of veterinary products. The registration and licensing of veterinary products commenced in August 2007. Until 2010, the total number of applications received for veterinary products was 2,806. (312 applications in 2010).

Registered Products

The decline in the number of applications received was subsequently reflected in the decline of the number of products approved for registration. Figure 2 shows that there was not much variation in the number of products registered each year (2006-2010) for prescription and non-prescription products. However, there was a fluctuation in the number of traditional products registered which was determined by the number of applications received. In 2010, for the first time, 54 veterinary products were approved for registration. The total cumulative figure for products registered until 2010 was 43,814 products (Figure 2).

22



Rajah 2 : Bilangan Kumulatif dan Bilangan Produk Didaftar, 2006-2010

Figure 2 : Cumulative Number of Products Registered and Number of Products Registered, 2006-2010

25,000

20,000

15,000

10,000

5000

0

2,0001,8001,6001,4001,2001,0008006004002000

533

2006

696

1729

-

11356

449

2007

413

1342

-

11805

409

2008

272

953

-

12214

8685 9098 9370

412

2009

313

1040

-

12626

9683

441

2010

235

582

54

13067

9918

16858 18200 19153 20193 20775

- - - - 54

Bila

ngan

Kum

ulat

if P

rodu

k D

idaf

tar

Cum

ulat

ive

Num

ber

of P

rodu

cts

Regi

ster

ed

Bila

ngan

Pro

duk

Did

afta

rN

umbe

r of

Pro

duct

s R

egis

tere

d

Preskripsi / Prescription

Bukan Preskripsi / Non-prescription

Semulajadi / Traditional

Veterinar / Veterinary

Semulajadi (Kum)/ Traditional (Accum)

Veterinar (Kum)/ Veterinary (Accum)

Preskripsi (Kum) / Prescription (Accum)

Bukan Preskripsi (Kum)/ Non-prescription (Accum)

40,00035,00030,00025,00020,00015,00010,000

5,0000

2,500

2,000

1,500

1,000

500

0





Semulajadi (Kum)/ Traditional (Accum)

Veterinar (Kum)/ Veterinary (Accum)

Preskripsi (Kum) / Prescription (Accum)

Bukan Preskripsi (Kum)/ Non-prescription (Accum)

465

2006

630

1526

-

17019

555

2007

560

1325

-

17574

604

2008

483

1120

570

18178

13159 13719 14202

492

2009

381

902

1924

18670

14583

402

2010

268

671

312

19072

14851

30072 31397 32517 33419 34090

- - 571 2494 2806

Bila

ngan

Kum

ulat

if P

erm

ohon

anC

umul

ativ

e N

umbe

r of

App

licat

ions

Bila

ngan

Pen

erim

aan

Perm

ohon

anN

umbe

r of

App

licat

ions

Rec

eive

d

Rajah 1 : Bilangan Kumulatif dan Bilangan Penerimaan Permohonan Pendaftaran Produk, 2006-2010Figure 1 : Cumulative Number of Application Received for Product Registration, 2006-2010

23


Produk ubat baru (NCE) yang diluluskan oleh PBKD pada tahun 2010 adalah sebanyak 20 produk (Jadual 1) manakala produk bioteknologi yang diluluskan oleh PBKD pada 2010 pula adalah sebanyak 18 produk (Jadual 2).

Bil. / No. NAMA PRODUK/ PRODUCT NAME

1 Bridion 100 mg/ml Solutuion for Injection2 Effient Film- coated Tablets 10 mg

Effient Film- coated Tablets 5 mg3 Epiduo 0.1%/2.5% Gel4 Exforge HCT 10/160/12.5 mg Film-coated Tablet

Exforge HCT 10/320/ 25 mg Film-coated TabletExforge HCT 5/160/ 25 mg Film-coated TabletExforge HCT 5/160/12.5 mg Film-coated TabletExforge HCT 5/160/25 mg Film-coated Tablet

5 Invega Sustenna 100 mg Prolonged Release Suspension for Intramuscular InjectionInvega Sustenna 150 mg Prolonged Release Suspension for Intramuscular InjectionInvega Sustenna 25 mg Prolonged Release Suspension for Intramuscular InjectionInvega Sustenna 50 mg Prolonged Release Suspension for Intramuscular InjectionInvega Sustenna 75 mg Prolonged Release Suspension for Intramuscular Injection

6 Multaq 400 mg Film coated tablets7 Omnaris Nasal Spray 50 mcg ( 60 puffs& 120 puffs)8 Onbrez Breezhaler 150 ug inhalation powder hard capsule

Onbrez Breezhaler 300 ug inhalation powder hard capsule9 Onglyza Tablet 2.5 mg

Onglyza Tablet 5 mg10 Priligy 30 mg Film- coated Tablets

Priligy 60 mg Film- coated Tablets11 Qlaira Film - coated Tablet12 RevolateTM Film coated Tablet 25g

RevolateTM Film coated Tablet 50 mg13 Rnevela ( Sevelamer Carbonate) tablet 800 mg14 Sifrol Extended Release tablet 0.375 mg

Sifrol Extended Release tablet 0.75 mgSifrol Extended Release tablet 1.5 mg

15 Thado capsule 50 mg16 Toviaz 4 mg prolonged release tablets

Toviaz 8 mg prolonged release tablets17 Vidaza powder for suspension for Injection 100 mg/vial18 Volibris 10 mg Film coated Tablet

Volibris 5 mg Film coated Tablet19 Votrient film coated tablet 200 mg

Votrient film coated tablet 400 mg20 Zolinza 100 mg capsule

20 New Chemical Entity (NCE) products (Table 1) and 18 biotechnology products (Table 2) were respectively approved by the DCA in 2010.

Jadual 1: Produk Ubat Baru yang diluluskan oleh PBKD pada tahun 2010Table 1: New chemical entity (NCE) products approved by the DCA in 2010

24



Bil./NO. NAMA PRODUK/PRODUCT NAME

1 Avastin concentrate for solution for infusion

2 Begrivac AC 2009/2010 suspension for injection in pre-filled syringe

3 Elonva 100 mg/0.5 ml Solution for Injection

Elonva 150 mg/0.5 ml Solution for Injection

4 Focetria suspension for Injection

5 Gamunex Solution for Injection

6 Humalog Mix 25 Kwikpen Suspension for Injection

Humalog Mix 50 Kwikpen Suspension for Injection

7 Humalog Kwikpen Solution for Injection

8 Intanza 15 mcg/strain suspension for injection

Intanza 9 mcg/strain suspension for injection

9 Mabthera concentrate for solution for infusion

10 Menactra Vaccine

11 Menveo Powder and solution for solution for Injection

12 Novoseven 1 mg powder and solvent for solution for Injection

Novoseven 2 mg powder and solvent for solution for Injection

13 Pergoveris 150iu/75iu powder and solvent for solution for injection

14 Prepandrix ( A/ Indonesia ) suuspension and emultion for Emultion for Injection

15 Prevenar 13 Suspension for Injection

16 Reopro Injection 10 mg/5 ml

17 Scitropin A 10 mg/1.5 ml ( 30 IU) Cartridge solution for Injection

Scitropin A 5 mg/1.5 ml (15 IU) Cartridge solution for Injection

18 Victoza solution for injection in prefilled pen

Jadual 2: Produk Bioteknologi yang diluluskan oleh PBKD pada tahun 2010

Table 2: Biotechnology products approved by the DCA in 2010

25


Produk Ditolak

Bilangan permohonan yang ditolak bagi semua kategori produk didapati meningkat (Rajah 3). Peningkatan ini adalah berikutan kegagalan pemohon untuk mengemukakan dokumen sokongan yang berkaitan dengan keselamatan, keberkesanan dan kualiti produk dalam tempoh yang ditetapkan oleh PBKD. Mulai tahun 2008, pemohon perlu mengemukakan maklumbalas dengan lengkap dalam masa 6 bulan. Oleh itu, peningkatan bilangan produk yang ditolak adalah lebih ketara pada tahun tersebut (terutamanya bagi produk tradisional) berbanding dengan tahun-tahun sebelumnya.

Rejected Products

An increasing trend was observed in the total number of applications rejected each year for all categories of products (Figure 3). This was due to the failure of applicants to submit supportive documents regarding the safety, efficacy and quality of the products in the allocated time frame. From 2008 onwards, applicants had to submit all the required documents within 6 months from the time of product dossier submission. As a result, there was a marked increase in the number of rejected products (especially for traditional products) in 2008 compared to other years.

Rajah 3: Bilangan Permohonan yang Ditolak, 2006-2010Figure 3: Number of Applications Rejected, 2006-2010

Bila

ngan

Per

moh

onan

Num

ber o

f App

licat

ions

350

300

250

200

150

100

50

0





25

2006

32

124

-

90

2007

59

191

-

171

2008

112

332

-

115

2009

84

137

6

205

2010

108

184

3

26



Imported Products by Sources

India accounted for 16.2% of the total number of imported prescription products in 2010. Most of these products were generic products. The main source of non-prescriptions products was from the United States which accounted for 27.4% of the total number of imported products for this category whereas China was the main source of traditional products. (Figures 5-7)

Produk Berdaftar Mengikut Sumber

Sebanyak 16.2% produk preskripsi yang berdaftar pada tahun 2010 adalah diimport dari India dimana kebanyakannya adalah produk generik. Amerika Syarikat adalah sumber utama untuk produk bukan preskripsi, iaitu sebanyak 27.4% manakala China merupakan sumber utama bagi produk semulajadi yang berdaftar. (Rajah 5-7).

Bila

ngan

Per

moh

onan

Num

ber o

f App

licat

ions

908070605040302010

0





4

2006

-

8

-

-

2007

2

64

-

90

2008

15

78

-

9

2009

11

40

-

14

2010

-

49

-

Produk Dibatal atau Ditarikbalik

Pada tahun 2010, terdapat peningkatan sebanyak 5% (Rajah 4) dalam bilangan produk yang dibatal/ditarikbalik bagi semua kategori produk berbanding tahun sebelumnya kecuali kategori produk bukan preskripsi. Ini adalah berikutan aktiviti pemantauan dan penguatkuasaan yang dijalankan secara berterusan ke atas semua kategori produk yang telah berdaftar.

Cancelled or Withdrawn Products

In 2010, there was an increase of 5% from 2009 (Figure 4) in the number of products cancelled/withdrawn for all product categories except non-prescription products. This was the result of increased monitoring activities on all registered products.

Rajah 4: Bilangan Produk yang Dibatal/Ditarikbalik, 2006-2010Figure 4: Number of Products Cancelled/ Withdrawn, 2006-2010

27


Bila

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Pro

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Num

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of P

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Indi

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Am

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Pera

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2500

2000

1500

1000

500

0

Bila

ngan

Pro

duk

Num

bers

of P

rodu

cts

Am

erik

a Sy

arik

atU

nite

d St

ates

Aust

ralia

Thai

land

Jerm

anG

erm

any

Uni

ted

King

don

Indi

a

indo

nesi

a

New

Zeal

and

Lain

-lain

Oth

ers

700

600

500

400

300

200

100

0

Rajah 6: Bilangan Produk Bukan Preskripsi Didaftar Mengikut Sumber Negara, 2010Figure 6: Countries of Main Sources for Importation of Non-Prescription Products, 2010

Rajah 5: Bilangan Produk Preskripsi Didaftar Mengikut Sumber Negara, 2010Figure 5: Countries of Main Sources for Importation of Prescription Products, 2010

28



Kebenaran Eksport

Sijil Produk Farmaseutikal (CPP) dalam format yang digariskan oleh WHO, dikeluarkan untuk produk yang dikilangkan oleh pengilang tempatan bagi tujuan eksport. Kebanyakan produk dieksport ke negara-negara ASEAN dimana Singapura merupakan negara yang paling teratas pada tahun 2010.

Export Permission

The Certificate of Pharmaceutical Product (CPP) which follows the format recommended by WHO is issued to locally manufactured products that are going to be exported. In 2010, most of these products were exported to ASEAN countries with Singapore being the lead trading partner for this market.

Rajah 8: Bilangan Pengeluaran Sijil Produk Farmaseutikal, 2010Figure 8: Issuance of Certificate of Pharmaceutical Product (CPP), 2010

Vietnam 8%

Indonesia 5%

Burma / Myanmar4%

Kemboja / Cambodia7% Filipina / Philipines

8%

Macau 6%

Sri Lanka 3%

Brunei 5%

Thailand 4%

Lain-lain /Others

39%

Singapura/Singapore

11%

Bila

ngan

Pro

duk

Num

bers

of P

rodu

cts

Chin

a

Am

erik

a Sy

arik

atU

nite

d St

ates

Taiw

an

Indi

a

Indo

nesi

a

Aust

ralia

New

Zea

land

Sing

apur

aSi

ngap

ore

Lain

-lain

Oth

ers

2000

1800

1600

1400

1200

1000

800

600

400

200

0

Rajah 7: Bilangan Produk Semulajadi Didaftar Mengikut Sumber Negara, 2010Figure 7: Countries of Main Sources for Importation of Traditional Products, 2010

29


Pertukaran Pemegang Pendaftaran Produk

Permohonan pertukaran pemegang pendaftaran produk yang diluluskan sepanjang tempoh 2006 hingga 2010 didapati agak tidak konsisten. Pertukaran pemegang pendaftaran hanya dibenarkan dengan persetujuan pemegang pendaftaran sekarang dan pemegang pendaftaran produk baru (Rajah 9).

Change of Product Registration Holder

There was a fluctuation in the trend of transfer of the product registration holder. A change was only allowed upon request by the current registration holder and agreed upon by the proposed product holder (Figure 9).

Rajah 9: Bilangan Permohonan Pertukaran Pemegang Pendaftaran Produk yang Diluluskan, 2006-2010Figure 9: Number of Change of Holder Applications Approved, 2006-2010

Rajah 10: Produk yang Diperbaharui Pendaftarannya, 2006-2010Figure 10: Number of Product Registration Renewal, 2006-2010

Bila

ngan

Per

moh

onan

Num

ber o

f App

licat

ions

2006 2007 2008 2009 2010

600

500

400

300

200

100

0

Bila

ngan

Pem

baha

ruan

Num

ber o

f Ren

ewal

2006 2007 2008 2009 2010

3500

3000

2500

2000

1500

1000

500

0

Pembaharuan Sijil Perakuan Pendaftaran Produk

Tempoh sah pendaftaran sesuatu produk adalah 5 tahun atau satu jangkamasa yang dinyatakan dalam Sijil Perakuan Pendaftaran Produk (kecuali pendaftaran digantung atau dibatalkan oleh PBKD). Bilangan pembaharuan pendaftaran produk pada tahun 2010 meningkat sebanyak 8.1% berbanding dengan tahun sebelumnya (Rajah 10).

Product Registration Certificate Renewals

The registration certificate of a product is valid for a period of five years or for such a period as specified in the product registration certificate (unless the registration is suspended or cancelled by the DCA). There was an increase of 8 % in 2010 from the previous year for the number of applications received for the renewal of product registration (Figure 10).

30



Aktiviti Berkenaan Cawangan Penguatkuasa Farmasi (CPF)

BPFK telah bekerjasama dengan Cawangan Penguatkuasa Farmasi dalam mengesahkan status pendaftaran produk. Produk-produk yang dirampas oleh cawangan Penguatkuasa farmasi dibawah Peraturan Kawalan Dadah & Kosmetik 1984 akan disahkan status pendaftarannya sebelum sebarang tindakan undang-undang diambil.

Bilangan pengesahan status pendaftaran produk untuk tujuan penguatkuasaan bertambah berbanding tahun-tahun terdahulu. Bagi tahun 2010, peningkatan bagi aktiviti ini adalah sebanyak 17.6% berbanding tahun 2009 (Rajah 11). Rajah 12 pula menunjukkan Cawangan Penguatkuasa Farmasi negeri Johor merupakan pihak yang paling banyak mengemukakan permintaan pengesahan status pendaftaran produk. Secara keseluruhannya, perkembangan ini mencerminkan peningkatan dalam aktiviti penguatkuasaan.

Cooperation with Pharmacy Enforcement Division

NPCB has been cooperating closely with the Pharmacy Enforcement Division in verifying the registration status of products. The registration status of products seized by the Pharmacy Enforcement Division under the Control of Drugs and Cosmetics Regulations 1984 would require verification before any legal action is taken.

There was an increasing trend in the number of request for product verification. In 2010, there was an increase of 17.6% in the number of requests received compared to the previous year (Figure 11). The most number of requests had been received from the Johor State Pharmacy Enforcement Division (Figure 12). This trend reflected an increase in the pharmacy enforcement activities to ensure that only safe, quality and efficacious products are in the market.

Bila

ngan

Pro

duk

Num

ber o

f Pro

duct

s

2006 2007 2008 2009 2010

12,000

10,000

8,000

6,000

4,000

2,000

0

Rajah 11: Verifikasi Status Pendaftaran Produk bagi Tujuan Penguatkuasaan, 2006-2010Figure 11: Verification of Product Registration Status for Enforcement Purposes, 2006-2010

31


5.0 CABARAN

Cabaran utama yang dihadapi oleh pusat ini adalah memastikan jangkamasa penilaian dan pendaftaran produk mematuhi piagam pelanggan. Penambahbaikan dalam proses penilaian perlu dibuat secara berterusan tanpa mengabaikan aspek mutu, keselamatan serta keberkesanan produk. Bebarapa tindakan yang telah diambil:

a) Perbincangan khas secara individu dengan syarikat pemohon yang dikenalpasti mempunyai permohonan tertunggak. Sesi perbincangan ini adalah bertujuan untuk meningkatkan pemahaman pemohon daripada segi keperluan pendaftaran serta menyelesaikan masalah yang dihadapi oleh pemohon demi melancarkan serta mempercepatkan pemprosesan permohonan.

b) Menghubungi pemohon melalui telefon, menjawab email atau membuat temujanji dengan pemohon serta member tunjukajar penggunaan sistem QUEST.

c) Mengadakan Bengkel dan seisi latihan untuk pemohon.

5.0 CHALLENGES

The main challenge faced by this centre is to ensure that all products are registered within the timeline specified in the client’s charter. Thus, the sections concerned have to find ways to better manage and expedite the evaluation process without compromising the quality, safety and effectiveness of the product. Among the measures taken include:

a) Discussions and interactions with applicants. These one-to-one sessions are intended to guide the applicant in terms of the requirements for registration and problem solving on grey areas in order to speed up the registration process.

b) Contacting applicants by phone calls, e-mails and letters and providing step by step technical guidance on using the QUEST 3 system.

c) Conducting workshops and training sessions for applicants

Johor 24%

Kelantan 4%

Kedah 2%

Melaka 3%

Negeri Sembilan 6%

Pahang 6%

Perak 10%Perlis 2%

Pulau Pinang 12%

Selangor 2%

Terengganu 3%

Sabah 15%

Sarawak 6%

Wilayah PersekutuanKuala Lumpur

4% WP Labuan 1%

Rajah 12 : Bilangan Produk yang Disemak Status Pendaftarannya oleh Cawangan Penguatkuasa Farmasi (Mengikut Negeri), 2010 Figure 12: Number of Product Registration Status Verified by the Pharmacy Enforcement Division (by state), 2010

32



d) Pembentukan Jawatankuasa Teknikal yang terdiri dari BPFK , industri dan persatuan bagi tujuan pengukuhan proses pendaftaran dari segi keselamatan, keberkesanan dan kualiti.

e) Pengemaskini Drug Registration Guidance Document (DRDG) melalui pelbagai bengkel dan mesyuarat supaya keperluan pendaftaran produk dapat difahami.

6.0 HALA TUJU

Pusat ini sentiasa berusaha untuk meningkatkan dan mengukuhkan pendaftaran produk farmaseutikal di Malaysia.

Tindakan yang diambil bagi memastikan keberkesanan produk generik adalah seperti berikut:

i) Produk dengan bahan aktif dalam kategori highly variables yang memerlukan penilaian yang lebih terperinci dan kritikal.

ii) Tambahan dari senarai sedia ada bahan aktif yang memerlukan kajian bioekuivalens (BE) ialah bagi produk-produk generik dengan bahan aktif bagi merawat pesakit psikiatrik juga memerlukan kajian bioekuivalens.

iii) Kursus dan latihan dalaman yang berterusan untuk meningkatkan bilangan pegawai penilai yang mempunyai kepakaran dalam bidang penilaian yang spesifik seperti bioekuivalens dan proses validasi.

Pusat Pendaftaran Produk juga sedang dalam proses mengawal bahan aktif farmaseutikal (API). Pengawalan ke atas API yang digunakan dalam produk adalah penting bagi memastikan produk siap yang didaftarkan adalah terjamin daripada aspek kualiti, efikasi dan keselamatan.

Pengawalan API akan dilaksanakan secara berperingkat bagi permohonan pendaftaran produk baru iaitu dimulakan secara voluntari mulai Mac 2011 bagi produk Entiti Kimia Baru dan secara mandatori mengikut fasa-fasa seperti berikut:

d) Organising Technical Working Group (TWG) sessions with representatives from the industries and associations in order to strengthen the registration process to ensure safety, efficacy and quality of registered products.

e) Updating the Drug Registration Guidance Document (DRGD) through various workshops and meetings to produce a more comprehensive guidelines to help applicants better understand the requirements for product registration.

6.0 THE WAY FORWARD

This centre is continuously looking into ways to further enhance and strengthen the registration of pharmaceutical products in Malaysia. Some of the measures taken to ensure the effectiveness of generic products are as follows:

i) Products with active ingredients from the highly variable categories will require more detailed and critical evaluations.

ii) In addition to the current active ingredients requiring BE studies, generic products with active ingredients intended to treat psychiatric patients will also require BE studies.

iii) Continuous in-house training and attachment courses are also conducted so as to increase the number of evaluators who are experts in specific areas such as bioequivalence and validation processes.

The Centre for Product Registration is also in the process of regulating active pharmaceutical ingredients (API). Controlling the APIs used in products is important to ensure that the final products registered are of quality, efficacious and safe.

The regulatory control of API will be implemented in phases beginning with voluntary submission of technical dossier data for New Chemical Entities (NCE) in March 2011 followed by mandatory implementation on other products according to phases as follows:

33


Fasa IProduk Entiti Kimia Baru (1 Januari 2012)

Fasa IIProduk generik yang mengandungi bahan aktif Racun Berjadual (Tarikh akan ditentukan kelak)

Fasa IIIProduk generik yang tidak mengandungi bahan aktif Racun Berjadual (Tarikh akan ditentukan kelak)

Pengawalan ke atas produk veterinar juga akan diperkukuhkan melalui aktiviti mewajibkan pengilang produk veterinary mempunyai status dengan Amalan Perkilangan Baik. Selaras dengan itu, pelesenan ke atas semua pengilang produk veterinar tempatan dijangka bermula pada 1 Januari 2012.

Garispanduan requirements for higher treatment claims/indications untuk Produk Semulajadi dan Suplemen Kesihatan sedang disediakan. Garispanduan ini akan mengambilkira keperluan regulatori Negara-negara ASEAN lain, Eropah, Kanada dan Australia.

Sehubungan dengan itu, satu Jawatankuasa Teknikal telah dibentuk. Mesyuarat jawatankuasa diadakan secara berkala dan Garispanduan dijangka akan mendapat kelulusan PBKD hujung tahun 2011.

Phase IProducts with NCE (1st January 2012)

Phase IIGeneric products containing Scheduled Poison as active ingredient (Date to be determined later)

Phase IIIGeneric products containing non-scheduled Poison as active ingredient (Date to be determined later)

The regulatory control of veterinary products will be further strengthened through the compulsory licensing of the manufacturers of veterinary products as well as licensing of local manufacturers which is expected to be effective on 1st January 2012.

Guidelines on the requirements for higher treatment claims/indications for traditional products and health supplements are in the pipeline. This guideline will take into consideration the regulatory requirements of other ASEAN countries, Europe, Canada and Australia so that Malaysia can emerge as a competitive partner for these products.

Several meetings have been held with the various stakeholders and this guideline is expected to be endorsed by the DCA in 2011.


PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL


36



1.0 PENGENALAN

Pusat Kawalan Kualiti (PKK) merupakan salah satu bahagian penting dalam BPFK yang bertanggungjawab dalam memastikan bahawa produk terapeutik yang diluluskan di pasaran Malaysia adalah selamat, berkesan dan berkualiti dan untuk memastikan bahawa ubat-ubatan semulajadi yang diluluskan dan kosmetik yang dinotifikasi adalah selamat dan berkualiti tinggi melalui aktiviti utama PKK iaitu pengujian dan penilaian dokumentasi analisis. Aktiviti-aktiviti ini dilaksanakan berdasarkan spesifikasi atau standard regulatori global dan dilakukan oleh personel PKK yang terlatih dan berkompeten.

2.0 OBJEKTIF

PKK akan terus berusaha untuk mencapai matlamat tersebut dengan meningkatkan dan memperkukuhkan sistem kawalan kualiti melalui objektif-objektif berikut:

• Pengujian dari aspek kimia dan biologi dijalankan berlandaskan prosidur dan metodologi yang mematuhi standad antarabangsa

• Penyelidikan dan pembangunan metodologi pengujian

• Pengeluaran piawai rujukan kimia dan biologikal untuk kegunaan institusi dan industri farmaseutikal tempatan.

• Memanfaatkan kepakaran untuk membantu pihak industri tempatan dan institusi yang berkaitan dalam bidang kawalan kualiti

• Penglibatan berterusan dalam kajian kolaboratif dan skim ujian profisiensi anjuran ASEAN, WHO, EDQM dan lain-lain agensi regulatori untuk memantapkan kebolehan dan kompetensi dalam bidang penganalisaan.

• Bekerjasama dengan Pusat Komplians dan Pelesanan dalam pengauditan kilang produk farmaseutikal, tradisional dan kosmetik untuk memastikan makmal kawalan kualiti pengilang mematuhi peraturan dan garispanduan yang ditetapkan.

1.0 INTRODUCTION

Centre for Quality Control (CQC) is an integral part of the National Pharmaceutical Control Bureau (NPCB). It is responsible in ensuring that the approved therapeutic products in the Malaysian market are safe, effective and of quality. It also ensures that the approved natural medicines and the notified cosmetics are safe and of high quality through testing and evaluation of analytical documentation, which are carried out in accordance with the global regulatory specifications / standard and performed by trained and competent CQC personnel.

2.0 OBJECTIVES

CQC will continuously strive to achieve the goal by improving and strengthening the quality control system through the following objectives:

• To carry out chemical and biological tests in compliance with the procedure and methodology of international standards

• To research and develop testing methodologies• To produce chemical and biological reference

standards for the use of local institutions and the pharmaceutical industries

• To optimize the expertise in assisting the local industry and related institutions in the areas of quality control

• To involve continuously in collaborative studies and proficiency testing scheme organised by the ASEAN, WHO, EDQM and other regulatory agencies to strengthen the ability and competence in the analytical field

• To collaborate with the Centre for Compliance and Licensing in auditing the manufacturers of pharmaceutical, natural medicines and cosmetics to ensure that their quality control laboratories comply with the prescribed regulations and guidelines.

PUSAT KAWALAN KUALITICENTRE FOR QUALITY CONTROL

37


3.0 AKTIVITI-AKTIVITI LAIN & 4.0 PENCAPAIAN

PKK tidak ketinggalan dalam memberi komitmen yang tinggi untuk mengekalkan pengiktirafan dari World Health Organisation (WHO) kepada BPFK sebagai sebuah Pusat Kolaborasi bagi Kawalan Regulatori Farmaseutikal semenjak tahun 1996. Berikutan dari pengiktirafan ini, beberapa pencapaian yang membanggakan telah dicapai oleh PKK pada tahun 2010 dan antaranya adalah:

• Sebagai penyelaras untuk pengeluaran dua bahan piawai rujukan ASEAN (ARS); Atenolol ARS dan Chlorpheniramine Maleate ARS

• Mengambil bahagian dalam kajian kolaboratif dan skim ujian profisiensi. Pada tahun 2010, ujian profisiensi berikut telah dijalankan:- “External Quality Assurance Assessment Scheme

Phase 5” anjuran WHO - “Chinese Medicine Proficiency Testing” anjuran IFM

Quality Services (Australia) - “Cadmium Content in Water” dan “Plumbum Content

in Food” anjuran Jabatan Kimia Malaysia- “Dissolution Testing of Paracetamol 500mg Tablet”

anjuran negara Thailand.• Memberi latihan dalam analisis kawalan kualiti

kepada pegawai-pegawai baru atau ahli-ahli WHO melalui skim latihan tempatan atau skim kooperasi antarabangsa.

• Menjalankan pengauditan ke atas 28 makmal kawalan kualiti pengilang di Malaysia untuk pematuhan terhadap Amalan Perkilangan Baik.

Pada Januari 2010, BPFK telah berjaya mendapat akreditasi MS ISO/IEC 17025:2005 dari Skim Akreditasi Makmal Malaysia (SAMM) untuk tatacara pengujian berikut:

- Pengujian arsenik, plumbum dan kadmium dalam produk-produk semulajadi

- Kontaminasi mikrobial dalam produk-produk semulajadi

- Pengecaian dalam produk-produk semulajadi - Keseragaman berat dalam produk-produk

semulajadi

3.0 OTHER ACTIVITIES & 4.0 ACHIEVEMENTS

Since 1996, CQC has given high commitment to maintain the recognition from the World Health Organisation (WHO) as a Collaborating Centre for Regulatory Control of Pharmaceuticals. Following this recognition, CQC had acquired a number of impressive achievements in 2010 including:

• Coordinated the establishment of two ASEAN reference standards (ARS); Atenolol ARS and Chlorpheniramine Maleate ARS.

• Taking part in various collaborative studies and proficiency testing. In 2010, these proficiency testing scheme include:

- External Quality Assurance Assessment Scheme Phase 5 organised by WHO

- Chinese Medicine Proficiency Testing organised by IFM Quality Services (Australia)

- Cadmium Content in Water and Plumbum Content in Food by Chemistry Department Malaysia

- Dissolution testing of Paracetamol 500mg Tablet organised by Thailand.

• Providing training on analytical testing techniques to new officers or WHO fellows through local training scheme or international cooperation scheme.

• Conducted audits on 28 quality control laboratories of local manufacturers for compliance with Good Manufacturing Practice (GMP).

In January 2010, CQC has successfully acquired an accreditation of MS ISO/ IEC 17025:2005 by Department of Standards Malaysia for following scopes:

- Testing of Arsenic, Lead and Cadmium in traditional products

- Microbial Contamination Test in traditional products- Disintegration test for traditional products- Uniformity of weight for traditional products

38



Penilaian Protokol dan Data Validasi Evaluation of Protocol Analysis and Validation Data

Bila

ngan

Num

ber

2006 2007 2008

TahunYear

Protokol Analisis / Protocol Analysis

Protokol Validasi / Protocol Validation

2009 2010

1,3351,243

460

76 5

440

576

1,939

2,233

1,820

2,500

2,000

1,500

1,000

500

0

Rajah 13: Penilaian Protokol dan Data validasi (2006 – 2010)Figure 13: Evaluation of protocol analysis and validation data (2006 – 2010)

Figure 13 shows the number of protocol of analysis and analytical validation data evaluated from 2006 - 2010. In 2008, there was a significant change in the total number of assessment due to the transformation of pharmaceutical product registration process in which pre-registration test sample was replaced with a full assessment of validation data. The decline in the amount of validation data evaluated in 2010 might be associated with the upgrading of the NPCB online system (from Quest 2 to Quest 3) that would need time for adaptation.

Rajah 13 menggambarkan jumlah protokol analisa dan data validasi analisis yang dinilai dari tahun 2006-2010. Pada tahun 2008, terdapat perubahan ketara bagi jumlah penilaian berikutan dari transformasi proses pendaftaran produk farmaseutikal di mana pengujian sampel pra-pendaftaran telah digantikan dengan penilaian lengkap data validasi. Jumlah penilaian data validasi pada tahun 2010 menunjuk penurunan yang mungkin disebabkan oleh penaiktarafan sistem dalam talian BPFK (daripada Quest 2 kepada Quest 3) yang memerlukan masa untuk mengadaptasi sistem tersebut.

39


Rajah 14: Jenis-jenis sampel mengikut kategori, 2010Figure 14: Types of samples by categories, 2010

PRESCRIPTIONNON-PRESCRIPTIONTRADITIONALCOSMETICVETERINARY

PRESCRIPTIONNON-PRESCRIPTIONTRADITIONAL

PRESCRIPTIONNON-PRESCRIPTIONTRADITIONALCOSMETICVETERINARY

PRESCRIPTIONNON-PRESCRIPTIONTRADITIONALCOSMETIC

REGISTRATION SURVEILLANCE

COMPLAINT CPF

Penerimaan Sampel

Pengujian sampel adalah salah satu aktiviti utama Pusat Kawalan Kualiti.

Rajah 14 menunjukkan kategori-kategori sampel yang diterima untuk pengujian pada tahun 2010. Produk-produk yang diuji adalah sampel pra-pendaftaran, pasca pendaftaran, sampel kes-kes aduan dan juga sampel dari penguatkuasa farmasi yang disyaki mengandungi bahan campurpalsu. Pengujian dijalankan berpandukan spesifikasi farmakopia-farmakopia antarabangsa, prosedur dalaman BPFK dan protokol analisa pengilang yang telah diluluskan.

Samples Received

Sample testing is one of the core activities of the Centre for Quality Control (CQC).

Figure 14 shows the different categories of samples received for testing in year 2010. Samples for testing were from pre-registered and post-registered samples, complaint cases. The tests are conducted based on international pharmacopoeias specifications, internal procedures as well as approved protocol specifications.

40



Secara keseluruhannya, Rajah 15 menggambarkan penurunan dalam jumlah sampel yang diterima untuk setiap kategori dari tahun 2006 hingga tahun 2010. Penurunan ini dipengaruhi oleh:

(i) Transformasi proses pendaftaran produk farmaseutikal pada tahun 2008, dimana pengujian sampel farmaseutikal untuk pra-pendaftaran telah digantikan dengan penilaian data validasi. Tahun seterusnya lebih menekankan pengujian sampel diperingkat pos-pendaftaran dan sampel pra-pendaftaran produk tradisional. Walaubagaimanapun, pengujian sampel pra-pendaftaran masih sedang dijalankan untuk aplikasi yang dikemukakan sebelum tahun 2008.

(ii) Penubuhan makmal forensik di Bahagian Perkhidmatan Farmasi telah menyebabkan pengurangan sampel diterima dari Penguatkuasa (CPF) untuk penyaringan bahan campurpalsu. Namun begitu, BPFK masih menerima sampel-sampel dari semua cawangan Penguatkuasa untuk tujuan pendakwaan atau kes mahkamah.

Figure 15 illustrates a reduction in the number of samples received for each category from 2006 to 2010. This was due to:

(i) The transformation of the pharmaceutical product registration process in 2008. The testing of pharmaceutical samples for pre-registration was substituted with the assessment of validation data. Since then, testing was focused on the post-registration samples and pre-registration traditional samples. However, pre-registration tests were still being carried out for applications submitted before 2008.

(ii) The establishment of forensic laboratories in the Pharmaceutical Services Division has resulted in a diminution of the sample received from Enforcement (CPF) for adulterants screening. However, NPCB still receives samples from other Enforcement branches for the purpose of prosecution or court cases.

Bila

ngan

Num

ber

Registration

1,48

7

1,11

674

8

2,07

6

2,14

4

2,29

6

2,23

62,

190

2,29

4

2,73

7

132

103

11614

9

119

408

1,09

966

0

268

192

53 0 8731

Surveillance ComplaintKategoriCategory

2006

2007

Enforcement(CPF)

Others

3,000

2,500

2,000

1,500

1,000

500

0

2008

2009

2010

Rajah 15: Jumlah sampel diterima mengikut kategori (2006-2010)Figure 15: Number of samples received by category (2006 – 2010)

41


Pengujian Sampel

Terdapat peningkatan sebanyak 3% untuk jumlah sampel yang diuji pada tahun 2010 berbanding dengan tahun 2009 (Rajah 16). Sampel-sampel dari pos-pendaftaran (pengawasan) dan Penguatkuasa merupakan penyumbang utama kepada peningkatan ini. Walaubagaimanapun, corak perubahan bagi jumlah sampel pendaftaran yang diuji sama dengan Rajah 15 di mana penurunan berlaku pada setiap tahun disebabkan oleh transformasi proses pendaftaran produk farmaseutikal.

Sample Testing

The total amount of samples tested in 2010 showed an increment of 3% compared to 2009 (Figure 16). The post-registration (surveillance) and enforcement samples were the major contributors to the increment. However, a similar pattern was observed in Figure 15, whereby the amount of samples being tested for registration purpose decreased every year due to the transformation process of the pharmaceutical product registration.

Bila

ngan

Num

ber

3,000

2,500

2,000

1,500

1,000

500

0

2006

2007

2008

2010

2,196

Registration

2,128

1,640

1,217

2,690

Surveillance

2,761

2,099

2,135

110

Complaint

155

122

129

156

CPF

270

369

775

35

Others

8

3

869 2,491 114 889 8

32009

Rajah 16: Jumlah sampel yang diuji mengikut kategori (2006 – 2010) Figure 16: Number of samples tested by category (2006 – 2010)

42



BIL DIUJI/ SAMPLES TESTED

BIL. GAGAL/ FAILED SAMPLES

% GAGAL/ % FAILED

Sampel Pendaftaran/ Registration Sample

Preskripsi/ Precription 13 3 23.08

Bukan-Preskripsi/ Non-Prescription 2 3 150

Semulajadi/ Traditional 854 93 10.89

Jumlah/ Total 869 99 11.39

Sampel Pengawasan/ Surveillance Sample

Preskripsi/ Precription 480 19 3.96Bukan-Preskripsi/ Non-Prescription 338 35 10.36

Semulajadi/ Traditional 1080 71 6.57Kosmetik/ Cosmetic 593 28 4.72

Veterinar/ Vetertinary NA NA NAJumlah/ Total 2491 153 6.14

Sampel Aduan/ Complaint Sample

Preskripsi/ Precription 49 16 32.65Bukan-Preskripsi/ Non-Prescription 12 3 25.00


Veterinar/ Vetertinary NA NA NAJumlah/ Total 114 45 39.47

CPF/ Enforcement


Veterinar/ Veterinary NA NA NALain-lain/ Others 11 6 54.55

Jumlah/ Total 885 304 34.35Lain-lain/Others

8 4 0

Jumlah/ Total 4367 605 13.85*NA = Not Applicable

Jadual 3 menunjukkan 13.85% sampel yang diuji didapati tidak menepati spesifikasi, kebanyakannya adalah sampel yang diterima dari Cawangan Penguatkuasa Farmasi (CPF) dan juga daripada aktiviti farmakovigilans yang dijalankan oleh Pusat Pasca Pendaftaran Produk.

*NA = Not Applicable

Table 3 shows that 13.85% samples tested were found to be out of specification. The highest contributions to this were samples received from Pharmacy Enforcement Division (CPF) as well as pharmacovigilance activity under the Centre for Post-Registration Products.

Jadual 3: Bilangan sampel yang tidak menepati spesifikasi, 2010Table 3: Number of samples with out of specification result, 2010

43


Pada tahun 2010, sejumlah 1358 sampel tradisional telah disaring untuk pengesanan bahan campurpalsu dan 23.7% daripadanya telah didapati mengandungi bahan campurpalsu (Rajah 17). Peningkatan ini disebabkan oleh usaha gigih pihak Penguatkuasa dalam aktiviti penyiasatan dan rampasan yang berkesan (Rajah 18).

In 2010, a total of 1358 traditional samples were screened for adulterants and 23.7% of these samples were found to contain adulterants (Figure17). The escalation was due to the increased effort of the Pharmacy Enforcement Division (CPF) in investigation and confiscation (Figure 18).

Rajah 17: Bilangan sampel yang diuji dan dikesan bahan campurpalsu (2006 – 2010)Figure 17: Number of samples tested and adulterated (2006 – 2010)

Rajah 18: Bilangan sampel dikesan positifbahan campurpalsu (mengikut kategori) 2010Figure 18: Number of adulterated samples (by category) 2010

1600

1400

1200

1000

800

600

400

200

0

2006 2007 2008 2009 2010

Bilangan sampel yang diujiNumber of samples tested

Bilangan sampel yang dikesan bahan campurpalsuNumber of adulterated samplesBi

lang

anN

umbe

r

339

728

593

1203

1358

75 114 138 184

308

YEAR

Registration2%

Surveillance (including compants)5%

CPF93%

44



Jadual 4 menunjukkan senarai bahan campur palsu yang dikesan dalam sampel produk semulajadi (tradisional) pada tahun 2010 dan kebanyakan bahan campur palsu ini menpunyai indikasi berikut:

• Untuk kesihatan lelaki• Untuk kesakitan otot dan sendi• Untuk mengurangkan berat badan• Untuk batuk dan selsema

Piawai Rujukan

Bahan piawai rujukan adalah kritikal elemen dalam pengujian kawalan kualiti. Ianya digunakan sebagai bahan perbandingan untuk pengesahan dan kuantifikasi bagi sesuatu bahan yang diuji. Unit Piawaian Rujukan yang ditubuhkan sejak dari 1994 bertanggungjawab menjalankan aktiviti-aktiviti yang melibatkan pembelian, pengeluaran, penyimpanan, pembekalan dan pengurusan bahan-bahan piawai rujukan kimia dan biologikal.

Table 4 shows the list of adulterants detected in natural (traditional) samples in the year 2010 and majority of these adulterants had the following indications:

• for men’s health• for joint and muscle pain• for reduction/control of body weight• for cough and cold

Reference Standard

Reference standard is a critical element in quality control testing. It is used as the comparison material for confirmation and quantification during testing. The Reference Standard Unit was established in 1994. This unit is responsible for activities pertaining to procurement, production, storage, supply and management of chemical and biological reference standards.

Bahan-bahan campurpalsu/Adulterants

Sampel CPF/CPF Samples

Sampel Pengawasan/Surveillance sample

Sampel Pendaftaran/ Registration sample

Ubat ED/ED Drugs1 56.59% 10.3% 10%

Steroid/Steroids2 16.25% 4.19% 2.6%

NSAIDs3 5.99% 1.86% 7.14%

Antihistamin/Antihistamines 39.38% 5.62% -

Antidiabetik/Antidiabetics - 16.67% -

Ubat Langsing badan/Slimming agents 19.63% 4.35% 2.4%

Local Anaesthetic 6.67% - -

Lain-lain/Others4 10.96% - -1sildenafil, tadalafil, analog sildenafil (acetildenafil, hydroxyhomosildenafil, homosildenafil, thiosildenafil, hydroxythiohomosildenafil, thiohomosildenafil, thiodimethylsildenafil), analog acetildenafil (nor-acetildenafil) dan analog tadalafil (aminotadalafil)2betamethasone, dexamethasone, prednisolone, prednisone, cortisone3diclofenac, mefenamic acid, ketoprofen, phenylbutazone4statins, niacinamide, phenolphthalein, psilocaine, cimetidine

Jadual 4: Bahan-bahan campurpalsu yang dikesan di dalam sampel produk semulajadi (tradisional) Table 4: List of Adulterants detected in natural (traditional) samples

45


Secara keseluruhannya, pembekalan piawai rujukan juga telah menurun pada tahun 2010 berbanding dengan tahun 2009 (Rajah 19). Penurunan ini dipengaruhi oleh penghapusan pengujian sampel farmaseutikal pra-pendaftaran dan kekurangan permintaan terhadap piawaian rujukan dari agensi-agensi kerajaan yang lain dan pengilang farmaseutikal.

In 2010, the supply of reference standards had declined in comparison to the previous year (Figure 19). This was mainly due to the abolishment of the pre-registration sample testing for pharmaceutical products and a decreased demand of reference standards from other government agencies as well as pharmaceutical manufacturers.

2006 2007 2008

TahunYear

Government Agency

Industry / Private

2009 2010

840

248 218 350153

605508

527

372 250

3,103

3,451

2,726

2,1422,001

3,500

3,000

2,500

2,000

1,500

1,000

500

0

NPCB Laboratory

2006 2007 2008

TahunYear

2009 2010

43

96

126

109

144160

140

120

100

80

60

40

20

0

Rajah 19: Bekalan Piawai Rujukan (2006 – 2010)Figure 19: Supply of Reference Standards (2006 – 2010)

Rajah 20: Bilangan Piawai Rujukan yang Disediakan (ASEAN & BPFK, 2006-2010)Figure 20: Reference Standards produced (ASEAN & NPCB 2006-2010)

46



Rajah 20 menunjukkan jumlah piawai rujukan yang disediakan. Piawai Rujukan kerja/sekunder BPFK disediakan dengan cara pemiawaian ‘Analytical Reference Material’ menggunakan piawai rujukan primer sebagai rujukan. Selain itu, BPFK juga bekerjasama dengan negara-negara ASEAN yang lain untuk menghasilkan Paiwai Rujukan ASEAN.

5.0 CABARAN

PBidang penyelidikan dan pembangunan metodologi pengujian merupakan cabaran utama PKK. Bidang ini memerlukan pengetahuan, kemahiran dan kepakaran teknikal secara menyeluruh dalam bidang kimia dan biologi farmaseutikal untuk memastikan metodologi yang dihasilkan berkualiti dan berinovasi. Selain daripada itu, bidang ini melibatkan pengurusan aktiviti-aktiviti penyelidikan dan pembangunan secara proaktif yang merupakan satu tanggungjawab besar terutamanya apabila berhadapan dengan isu ‘rapid alert’ yang berkaitan keselamatan produk di pasaran Malaysia.

PKK menghadapi cabaran lebih ketara dalam pengesanan bahan-bahan campurpalsu yang mengandungi bahan-bahan analog contohnya sildenafil dan sibutramine analog. Cabaran ini memerlukan pesonel PKK dilengkapi dengan kemahiran dan kepakaran dalam bidang isolasi, ekstrasi dan purifikasi dan kefahaman menyeluruh dalam elusidasi struktur dan interpretasi data dari peralatan analisis. Sejajar dengan kertas polisi Pihak Berkuasa Kawalan Dadah berhubung dengan perlaksanaan Kawalan Active Pharmaceutical Ingredient dan pendekatan kimia (‘chemotaxonomy’) untuk menentusahkan spesis tumbuhan dalam produk-produk tradisional melalui pengesanan penanda tumbuhan (‘bio-marker’) juga memerlukan kemahiran dan kepakaran sedemikian.

6.0 HALATUJU

Perluasan skop akreditasi MS ISO/IEC 17025:2005 dengan penambahan ujian-ujian berikut:

- Ujian pengesanan arsenik, plumbum, kadmium dan merkuri dalam produk kosmetik dan produk supplemen kesihatan.

- Ujian pengesanan dan penentuan Lovastatin dalam serbuk & kapsul produk semulajadi

- Ujian pengesanan Sildenafil, Tadalafil & Vardenafil dalam produk semulajadi

- Ujian pengesanan dan penentuan kandungan Hydroquinone dalam krim produk kosmetik.

Figure 20 shows the amount of reference standards produced. NPCB Working/Secondary Standards were produced by standardization of the certified reference materials against primary standards. Apart from this, the NPCB also collaborates with other ASEAN countries to produce ASEAN Reference Standards.

5.0 CHALLENGES

Research and development of testing methodologies is a major challenge for CQC. This field requires knowledge, skills and extensive technical expertise in the field of chemical and biological pharmaceutics. This is to ensure that the testing methods developed are innovative and of quality. In addition, it is a huge responsibility to manage this field proactively, particularly when dealing with ‘rapid alert’ issue relating to the safety of products in the Malaysian market.

CQC encounters significant challenges in the detection of adulterants containing analogue such as sildenafil analogue and sibutramine analogue. These challenges require CQC personnel to be equipped with the knowledge, skills and expertise in isolation, extraction and purification. Apart from that, they also need to understand the structural elucidation as well as having the capabilities of interpreting analytical data. The same skills and expertise are needed in verifying the plants species in natural medicinal products through bio-marker detection. This is in line with the Drug Control Authority (DCA) policy paper regarding the implementation of Active Pharmaceutical Ingredient Control and chemical approaches (chemotaxonomy).

6.0 THE WAY FORWARD

Accreditation scope extension in MS ISO/IEC 17025:2005 with the additional tests as below:

- Testing method of Arsenic, Lead, Cadmium and Mercury in cosmetic and health supplement products

- Testing method of lovastatin in traditional products- Testing method for screening of sildenafil, tadalafil

and vardenafil in traditional products- Testing method for screening and determination of

hydroquinone in cream cosmetic products.

47


PKK akan menggiatkan usaha untuk mentauliahkan lebih ramai juruaudit kawalan kualiti makmal (dalam bidang kimia dan mikrobiologi) untuk mengukuhkan pematuhan Amalan Perkilangan Baik (APB) dalam industri tempatan.

PKK akan meneruskan validasi ke atas tatacara pengujian produk semulajadi seperti berikut:

- Penyaringan ephedrine and pseudoephedrine menggunakan kaedah High Performance Liquid Chromatogram (HPLC).

- Analisis pengesahan Ortosiphon stamineus (Misai Kucing) dalam produk-produk semulajadi dengan menggunakan penanda kimia Sinensetin dengan kaedah HPLC.

- Analisis pengesahan Eurycoma longifolia (Tongkat Ali) dalam produk-produk semulajadi dengan menggunakan penanda kimia Eurycomanone dengan kaedah HPLC.

- Penyaringan betamethasone-17-valerate, dexamethasone dan hydrocortisone dalam produk semulajadi campurpalsu dengan menggunakan kaedah HPLC.

- Penyaringan sildenafil, tadalafil dan vardenafil dalam produk semulajadi campurpalsu dengan kaedah HPLC.

- Penyaringan Phentermine and Sibutramine dalam produk semulajadi campurpalsu dengan kaedah Gas Chromatography-Mass Spectroscopy (GC-MS).

PKK akan berusaha untuk membangunkan metodologi (R&D) seperti berikut:

- Penentuan hydroquinone, arbutin and azelaic acid dalam keluaran kosmetik menggunakan kaedah GC-MS.

- Penyaringan alkaloid Lobeline dalam produk semulajadi yang mengandungi Lobelia spp. menggunakan kaedah HPLC.

- Penyaringan mikotoksin Citrinine dalam produk tradisonal yang mengandungi Red Yeast Rice menggunakan kaedah HPLC.

PKK turut meneruskan penglibatan aktif dalam pembangunan Monograf Herba Malaysia bersama dengan institusi kerajaan yang berkaitan, universiti dan industri semulajadi tempatan.

PKK bercadang untuk menubuhkan unit-unit baru dalam pengujian bahan aktif farmaseutikal (API), produk-produk vaksin dan bioteknologi untuk memastikan keselamatan, kualiti dan efikasi produk-produk ini.

CQC is determined to train and authorize more competent/qualified quality control laboratory auditors (in chemical & microbiology) for the purpose of enhancing GMP compliance within local pharmaceutical industries.

CQC endeavors to validate the following developed in-house methods on traditional products :

- Screening of ephedrine and pseudoephedrine using High Performance Liquid Chromatography (HPLC) method.

- Authentication analysis of Orthosiphon stamineus (Misai Kucing) in traditional products using sinensitin biomarker by HPLC method.

- Authentication analysis of Eurycoma longifolia root (akar Tongkat Ali) in traditional herbal medicinal products using Eurycomanone biomarker by HPLC method.

- Screening of betamethasone-17-valerate, dexamethasone and hydrocortisone in traditional herbal medicinal products using HPLC method.

- Screening of sildenafil, tadalafil and vardenafil in traditional herbal medicinal products using HPLC method.

- Screening of Phentermine and Sibutramine in traditional herbal medicinal products using Gas Chromatography-Mass Spectroscopy (GC-MS) method.

CQC is also striving to develop methodologies as below:

- Determination of hydroquinone, arbutin and azelaic acid in cosmetic products using GC-MS method.

- Screening of Lobeline alkaloid in traditional products containing Lobelia spp using HPLC method.

- Screening of citrinine mycotoxin in natural (traditional) products containing red yeast rice using HPLC method.

CQC will continue to participate in development of Malaysia Herbal Monograph in collaboration with other government institutes, universities and local traditional industries.

CQC will establish new laboratory testing units to venture in analytical testing of Active Pharmaceutical Ingredient (API), vaccines and biotechnology products in order to ensure the safety, quality and efficacy of these products.


PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION OF PRODUCTS


50



PENGENALAN

Pusat Pasca Pendaftaran Produk (PPPP) bertanggungjawab dalam memastikan semua produk berdaftar dan kosmetik bernotifikasi mematuhi garispanduan dan memenuhi keperluan perundangan. Pusat ini terdiri daripada empat (4) seksyen iaitu Seksyen Surveilans dan Aduan, Seksyen Farmakovigilans, Seksyen Variasi dan Seksyen Kosmetik.

1.0 PROGRAM SURVEILANS

1.1 OBJEKTIF

- Memastikan semua produk berdaftar dan kosmetik bernotifikasi mematuhi syarat-syarat pendaftaran/notifikasi dari segi kualiti dan keselamatan.

- Menguruskan tindakan punitif ke atas produk berdaftar/kosmetik bernotifikasi yang tidak mematuhi syarat-syarat pendaftaran/notifikasi.

1.2 AKTIVITI-AKTIVITI

- Aktiviti-aktiviti di bawah program ini adalah persampelan produk berdaftar/kosmetik bernotifikasi yang berada di pasaran, pemantauan ke atas pematuhan label dan sisip bungkusan.

- Mengendalikan aduan produk yang diterima berkaitan isu keselamatan, kualiti, dan keberkesanan.

INTRODUCTION

The Centre for Post Registration of Products is responsible in ensuring that all registered products and notified cosmetics conform to the established standards and requirements of the legislation. The centre consists of four (4) sections namely Surveillance and Product Complaints Section, Pharmacovigilance Section, Variation Section and Cosmetic Section.

1.0 SURVEILLANCE PROGRAM

1.1 OBJECTIVES

- To ensure that registered products and notified cosmetics in the local market meet the quality and safety requirements.

- To manage the punitive actions taken on registered products/notified cosmetics that fail to comply with registration/notification requirements.

1.2 ACTIVITIES

- The activities include sampling of product/cosmetic available in the market, and monitoring of labels and product inserts (PI).

- Receiving and investigating of complaints regarding safety, quality, or efficacy issues of registered products.

2007 2008

TahunYear

Poison

Bila

ngan

Pro

duk

Num

ber o

f Pro

duct

s

Non-poison

2009 2010

386417

1376

359

526

434

1012

300

482

411

903

735

996

458

759 684

1,600

1,400

1,200

1,000

800

600

400

200

0

Traditional

Cosmetic

Rajah 21: Bilangan produk yang terlibat dalam PMS 2007-2010Figure 21: Number of products involved in PMS 2007-2010

PUSAT PASCA PENDAFTARAN PRODUKCENTRE FOR POST REGISTRATION OF PRODUCTS

51


1.3 PENCAPAIAN

Persampelan Produk

Sejumlah 2897 produk berdaftar/kosmetik bernotifikasi telah disampel di bawah Program Pengawasan Mutu Produk Berdaftar/Kosmetik Bernotifikasi bagi tahun 2010. Jumlah ini meningkat 9% berbanding tahun sebelumnya.

Pada 2010, peratusan produk yang disampel mengikut kategori adalah seperti berikut: racun (34%), tradisional (26%), kosmetik (24%) dan bukan racun (16%).

1.3 ACHIEVEMENTS

Product Sampling

A total of 2897 products/notified cosmetics were sampled in year 2010 under the Post Marketing Surveilance Program. The total increased by 9% compared to year 2009.

In 2010, the percentage of products sampled according to their categories were: poison (34%), traditional (26%), cosmetic (24%) dan non-poison (16%).

Bila

ngan

Pro

duk

Num

ber o

f Pro

duct

s

1,200

1,000

800

600

400

200

0

FAIL

PASS

10

Poison

437

24

Non-poison

171

63

Traditional

956

32

Cosmetic

97.8%

87.7%

93.8%

94.5%

551

Rajah 22 : Bilangan produk yang dijalankan ujian makmal dan peratus kelulusannya, 2010Figure 22: Number of products that undergone laboratory tests and their passing percentage, 2010

52



Keputusan Pengujian Makmal

Daripada sejumlah 2244 sampel yang dianalisa, sebanyak 2115 (94.3%) lulus ujian makmal. Peratusan produk yang gagal ujian makmal mengikut kategori adalah seperti berikut: bukan racun (14%), tradisional (6.6%), kosmetik (5.8%) dan racun (2.3%). Tindakan telah diambil berdasarkan kepada tahap kegagalan ujian berkenaan.

Laboratory Tests Results

A total of 2115 (94.3%) out of 2244 samples passed laboratory tests. The percentage of category of product failing the laboratory tests are as follow: non-poison (14%), traditional (6.6%), cosmetic (5.8%) dan poison (2.3%). Appropriate actions were taken based on the level of test failure.

Traditional56.60%

Cosmetic34.20%

Poison6.60%Non-poison

2.60%

Racun / PoisonBukan racun / Non-poisonTradisional / TraditionalKosmetik / Cosmetic

52

4326

Rajah 24 : Jumlah dan peratusan panggil balik produk tahap III bagi setiap kategori produk, 2010Figure 24: Category of products directed for degree III product recall, 2010.

Num

ber o

f Rec

alls

2007 2008 2009 2010

144

113 110

77

150

100

50

0

Rajah 23: Bilangan panggil balik produk bagi 2007-2010Figure 23: Number of product recalls from 2007-2010

53


Tindakan Punitif

Bagi tahun 2010, bilangan arahan panggil balik yang dikeluarkan ke atas produk adalah sebanyak 77 dan ini adalah rendah berbanding dengan tahun-tahun sebelumnya seperti yang di tunjukkan pada rajah 23. Pengkelasan panggil balik adalah berdasarkan risiko produk yang tidak mematuhi piawaian terhadap keselamatan atau kesihatan pengguna.Satu (1) produk bukan preskripsi telah diarahkan panggil balik tahap I atas sebab kegagalan ujian kritikal. Sebanyak 76 produk terlibat dalam panggil balik tahap III, kebanyakannya merupakan produk semulajadi yang gagal ujian had mikrobial dan had logam berat. Selain tindakan panggil balik, surat amaran telah dikeluarkan ke atas 25 produk yang gagal ujian seperti keseragaman berat.

Aduan

Bilangan aduan yang diterima pada tahun 2010 menunjukkan peningkatan sebanyak 42.9% berbanding tahun sebelumnya. Semua aduan yang diterima perlu disiasat. Sebanyak 593 aduan yang diterima telah diselesaikan dalam tahun semasa.Sebanyak 89.2% diselesaikan tanpa tindakan punitif, 3.4% diberikan amaran bertulis, 2.7% aduan dirujuk ke bahagian lain yang berkenaan, 2.4% panggil balik secara sukarela oleh pihak syarikat, 1.3% melibatkan arahan panggil balik dan 1.0% dibatalkan notifikasi kosmetik.

Punitive Action

For the year 2010, the total number of product recalls was 77 and this was much lower as compared to the previous years as shown in figure 23. The degree of recalls is decided based on the risk of the product not fulfilling the standard of quality, safety and efficacy. One (1)non-poison product required a first degree recall due to the failure of critical laboratory test.A total of 76 products involved third degree recalls whereby most of them were traditional products that failed microbial limit test and heavy metal test. Besides product recall, warning letters had been issued for 25 products that failed tests such as uniformity of weight.

Complaints

The number of complaints received in year 2010 showed an increase of 42.9% compared to 2009. All complaints that were received would be investigated. A total of 593 complaints were resolved within the same year as they were received. Among these complaints, 89.2% were resolved without any punitive actions taken; 3.4% were issued with warning letters; 2.7% were forwarded to other departments for investigation; 2.4% involved voluntary product recall by the product holders; 1.3% was directed for product recall and in 1.0% of the complaints, the cosmetic notification was cancelled.

2008

Num

ber o

f Com

plai

nts

Rece

ived

2009 2010

149

263

20 36

119

317

2167

158

546

1926

600

500

400

300

200

100

0

Poison Non-poison Traditional Cosmetic

Rajah 25 : Bilangan aduan yang diterima mengikut kategori produk, 2008-2010Figure 25: The number of complaints received by product category, 2008-2010.

54



Tindakan Regulatori atas Isu Campurpalsu

Senarai produk atau kosmetik yang dibatalkan pendaftaran/notifikasi berikutan isu campurpalsu pada tahun 2010:

Rangkaian Hubungan ASEAN dan Antarabangsa

Malaysia merupakan ahli rangkaian perkongsian maklumat berkenaan keselamatan dan kualiti produk kesihatan dan kosmetik antara negara-negara ASEAN melalui ASEAN Post Marketing Alert System (PMAS) dan juga negara luar ASEAN melalui PIC/S Rapid Alert Notification System (RAS).Ini adalah untuk memastikan maklumat terhadap isu-isu kualiti dan keselamatan bagi produk kesihatan dan kosmetik dapat dicapai secara menyeluruh dan tindakan regulatori yang pantas dapat diambil. Sebanyak 327 laporan PMAS dan 60 laporan RAS telah diterima dan disaring bagi produk kesihatan dan kosmetik. Malaysia telah mengeluarkan sejumlah 23 laporan alerts kepada negara-negara ASEAN pada tahun 2010 yang melibatkan produk 8 produk kategori ubat tradisional dan 15 produk kosmetik.

Regulatory Action Taken on Adulteration Issue

List of products or cosmetics for which the registration/notification had been cancelled in 2010 due to adulteration:

ASEAN and International Communication Network

Malaysia is part of the information sharing network in regards to the safety and quality of health and cosmetic products, with ASEAN countries via the ASEAN Post Marketing Alert System (PMAS) and with countries outside the ASEAN via the PIC/S Rapid Alert Notification System (RAS). This enabled information regarding safety and quality of health and cosmetic product to be received in a timely manner and regulatory action can be taken quickly. A total of 327 PMAS and 60 RAS reports were received for health products and cosmetics. Malaysia had issued 23 alerts to the ASEAN countries in 2010, which involved 8 traditional products and 15 cosmetics.

BIL.NO.

NAMA PRODUKPRODUCT NAME

NO. PENDAFTARAN atau NO.NOTIFIKASI

REGISTRATION NUMBER or NOTIFICATION NUMBER

BAHAN CAMPUR PALSU YANG DIKESANSUBSTANCE DETECTED

1. 357 Nasal Spray MAL06061468T Dexamethasone2. Amberine Capsule MAL06021239T Metformine dan Sibutramine3. Goji Plus Capsule MAL08051654TC Sildenafil analogue4. NCHK Pil Zhi Ke MAL06030949T Dextromethorphan5. Promax Capsule MAL08082464TC Sildenafil analogue6. Vegrow MAL08111900TC Sildenafil analogue7. Vng400 MAL20081810TE Sildenafil analogue8. NV Toner Treatment No 1 NOT05010130KE Hydroquinone9. NV Toner Treatment No 2 NOT05010130KE Hydroquinone

10. Zara Rejuvenation Cream NOT04081873KE Hydroquinone11. Beauty Line Beautitude Multi-Purpose Cream NOT081201209K Tretinoin12. Pigmentation Recovery Complex NOT081200745K Tretinoin13. De Putih Night Cream NOT05100878KE Tretinoin14. BML HB Lotion NOT090701336K Tretinoin & Hydroquinone15. Krim Malam Shana NOT090600820K Tretinoin & Hydroquinone16. Natasya Gold Krim Herba NOT091100971K Tretinoin & Hydroquinone17. Biotox Whitening Hydro Cream NOT07061310KE Dexamethasone18. Yoko Whitening Cream NOT080100330K Tretinoin19. Sue Beauty Night Treatment Cream NOT080600138K Tretinoin

55


2.0 FARMAKOVIGILANS

2.1 OBJEKTIF

- Mengurangkan kejadian ADR dan menggalakkan pelaporan ADR.

- Mengemaskini profil keselamatan produk.


- Sekretariat kepada Jawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC) untuk menguruskan pengesanan dan pemonitoran kesan advers ubat (ADR), mengenalpasti langkah-langkah untuk mengurangkan kejadian ADR dan menggalakkan pelaporan ADR.

- Menganggotai Program Pemonitoran Ubat Antarabangsa World Health Organisation (WHO).

- Memantau maklumat keselamatan produk yang diterima daripada agensi regulatori lain dan `signal detection’ dari laporan tempatan.

2.3 PENCAPAIAN

Bilangan laporan ADR yang diterima sepanjang tahun 2010 telah meningkat sebanyak 21% berbanding tahun 2009. Peningkatan pelaporan ADR setiap tahun disebabkan oleh usaha mempromosikan pelaporan ADR, melalui bengkel dan ceramah yang diadakan dari semasa ke semasa. Peningkatan yang ketara juga didapati pada pelaporan AEFI untuk tahun 2010 disebabkan oleh pelaksanaan program imunisasi Human Papillomavirus (HPV) dan penggunaan vaksin H1N1 semasa wabak H1N1.

2.0 PHARMACOVIGILANCE

2.1 OBJECTIVES

- To reduce the incidence of ADR and encourage ADR reporting.

- Update product safety profile.

2.2 ACTIVITIES

- The Secretariat for MADRAC (Malaysian Adverse Drug Reaction Advisory Committee), in charge of collecting, detecting and monitoring of ADR.

- A member of the International Drug Safety Program initiated by the World Health Organisation (WHO).

- Monitor product safety information from other regulatory agencies and detect signals from local reports.

2.3 ACHIEVEMENTS

The total number of reports received in 2010 had increased by 21% compared to 2009. The rise in ADR reports per year was a result of efforts to promote awareness on ADR reporting through workshops and talks held from time to time. The drastic increase in AEFI reports in 2010 was due to the launching of the national Human Papillomavirus (HPV) immunisation program as well as the usage of H1N1 vaccines in the face of the H1N1 pandemic.

Rajah 26: Bilangan laporan ADR yang diterima mengikut kategori pelapor 2007-2010Figure 26: Number of ADR reports received by reporters 2007-2010.

8,000

7,000

6,000

5,000

4,000

3,000

2,000

1,000

0

2007 2008 2009 2010

Number of ADR Report

Number of Vaccine-related ADR Report

Bila

ngan

Num

ber

3,068

4,826

5,850

7,079

75 135242

1,565

YEAR

56



Pengamal kesihatan profesional dari sektor kerajaan merupakan penyumbang utama kepada jumlah pelaporan ADR diterima dan majoriti laporan adalah dilapor oleh pegawai farmasi dari sektor kerajaan dengan jumlah 4160 laporan dan menyumbang kepada 19.2% peningkatan berbanding dengan jumlah pada tahun sebelumnya. Bilangan laporan ADR yang diterima daripada pengamal kesihatan profesional sektor swasta juga menunjukkan peningkatan sebanyak 72.2% (248 laporan) berbanding tahun 2009 (144 laporan).

Sebanyak 7755 produk telah terlibat dengan pelaporan ADR untuk tahun 2010 dimana 7134 (92.0%) daripadanya ialah produk preskripsi, 443 (5.7%) produk bukan-preskripsi dan 176 produk (2.3%) yang lain iaitu ubat tradisional, kosmetik, makanan dan produk tidak berdaftar. Selain vaksin, ubat kardiovaskular menyumbang kepada bilangan terbanyak iaitu 1451 (26.1%) dan diikuti dengan ubat anti-infektif iaitu sebanyak 1172 produk (21.0%) dan seterusnya ubat analgesik iaitu sebanyak 548 produk (9.8%). Trend ini mirip dengan trend 2009.

Government healthcare professionals contribute to the largest portion of ADR reports received each year. The majority of these reports were provided by government pharmacists with a total of 4160 reports, a 19.2% increase from the previous year. The number of ADR reports from private healthcare professionals had increased as much as 72% from 2009 (from 144 reports to 248).

The ADR reports received in 2010 involved 7755 suspected products of which 7134 (92.0%) were prescription products, 443 (5.7%) non-prescription products and the remaining 176 products (2.3%) were traditional medicine, cosmetics, food and unregistered products. Apart from vaccines, cardiovascular products contributed to the highest number of reports with a total of 1451 (26.1%) products, followed by 1172 (21.0%) anti-infective products, and 548 (9.8%) analgesics. This trend is similar to that seen in 2009.

Rajah 27: Bilangan ADR yang diterima mengikut kategori produk 2010Figure 27: Number of ADR reports received by product category 2010.

Poison

Non-poison

Unregistered Products

Traditional Products

Food

Cosmetic

KAT

EGO

RI P

ROD

UK

PRO

DU

CT C

ATEG

ORY

BILANGAN LAPORANNUMBER OF REPORTS

0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000

7,134

443

96

57

18

5

57


Rajah 28: Analisis laporan ADR mengikut System Organ Class (SOC) 2010Figure 28: Analysis of ADR reports by System Organ Class (SOC) 2010.

HEART RATE AND RHYTHM DISORDERSURINARY SYSTEM DISORDERS

PSYCHIATRIC DISORDERSMUSCULO-SKELETAL SYSTEM DISORDERS

APPLICATION SITE DISORDERSRESPIRATORY SYSTEM DISORDERS

GASTRO-INTESTINAL SYSTEM DISORDERSCENTRAL&PERIPHERAL NERVOUS SYSTEM DISODERS

BODY AS A WHOLE- GENERAL DISORDERSSKIN AND APPENDAGES DISORDERS 206

0 500 1,000 1,500 2,000 2,500 3,000

320

506

681

891

898

1,564

2,004

2,183

2,637

BILANGAN KESAN ADVERSNUMBER OF REACTION

ADR yang paling banyak dilaporkan ialah yang melibatkan SOC ‘Skin and Appendages Disorders’ (20.2%). Ini diikuti oleh ‘Body as a Whole- General Disorders’ (16.7%) dan seterusnya SOC ‘Central and Peripheral Nervous System Disorders’ (15.4%).

Selangor menjadi negeri yang paling aktif membuat pelaporan ADR untuk tahun 2010 (22.0%) diikuti oleh Sabah (12.5%) dan Perak (11.9%).

Promosi Meningkatkan Pelaporan ADR

Seksyen Farmakovigilans telah dijemput untuk mengadakan ceramah dan bengkel di institusi dan universiti untuk tujuan meningkatkan kesedaran kepentingan melaporkan kejadian advers ubat dan vaksin serta meningkatkan kualiti pelaporan ADR.

Most of the adverse events reported involved ‘Skin and Appendages Disorders’ (20.2%), followed by ‘Body as a whole- General Disorders’ SOC (16.7%) and ‘Central and Peripheral Nervous systems Disorders’ SOC (15.4%).

Selangor emerged as the most active state in the ADR reporting for the year of 2010 (22.0%) followed by Sabah (12.5%) and Perak (11.9%).

Promoting ADR Reporting

The Pharmacovigilance Section had conducted talks and workshops at institutions and universities to promote awareness on the importance of reporting adverse events from use of medications and vaccines as well as to increase the quality of ADR reports.

TAJUK CERAMAHPRESENTATION TOPIC

BILANGAN CERAMAH YANG DIBERIKAN SEPANJANG 2010

NUMBER OF TALKS GIVEN THROUGHOUT 2010

Pharmacovigilance 3Adverse Drug Reaction Reporting and Monitoring 8Adverse Drug Reaction Reporting and Vaccine 2Risk Management and Risk Assessment Plan 1Adverse Drug Reaction Related To Skin Therapy 1Adverse Drug Reactions And Medication Errors Associated With Cytotoxic Drugs 1Adverse Event Following Immunisation (AEFI) 4

58



Tindakan Regulatori PBKD

Di bawah adalah arahan yang dikeluarkan oleh PBKD berkenaan produk farmaseutikal menyusur alert yang diterima daripada agensi regulatori antarabangsa atau tempatan.

DCA Regulatory Action

These were the major directives issued by the DCA on pharmaceutical products following the alerts received from other international regulatory agencies as well as from local institutions.

BILNO.

MESYUARAT PBKD DCA MEETING

PRODUK YANG TERLIBAT PRODUCTS INVOLVED

DESKRIPSIDESCRIPTION

1 224 (28/1/2010) All products containing sibutramine

-To include SCOUT (Sibutramine Cardiovascular Outcome Trial) study summary description into package inserts.-Result of the SCOUT study suggested that sibutramine is associated with increased cardiovascular risk.

2 227 (29/4/10) All products containing red yeast rice (monascus purpureus)

-To limit the dose of traditional medicines containing red yeast rice to ensure content of lovastatin consumed is less than 10mg/day.-To add a warning statement regarding concurrent use of statins or fibrates to the product labels.-Concurrent use of fibrates may cause severe myositis and myoglubinuria.

3 228 (27/5/2010) All products containing propylthiouracil

-To add a box warning regarding the incidence of “severe liver injury and acute liver failure” into package inserts.

4 228 (27/5/2010) All products containing carbocysteine, acetylcysteine and methylcarbocysteine (Mecysteine)

-To add in the statement “contraindicated in children below 2 years of age” in the package inserts.-This is due to the findings of AFSSAPS (French Health Agency) showing there is risk of aggravation of respiratory symptoms following the consumption of the mentioned products.

5 234 (22/11/2010) All products containing rosiglitazone

-To revise the indication, contraindication and warning and precaution parts of package insert.-Rosiglitazone is contraindicated in patients with NYHA Class I to IV heart failure or history of cardiac failure, ischaemic heart disease, and Acute Coronary Syndrome (unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI)).-Rosiglitazone is to be prescribed to new patients only if they are unable to achieve adequate blood glucose control with all other oral antidiabetic medications.

6 235 (23/12/2010) All products containing sibutramine

-To cancel the registration of all sibutramine products and not to register any new products containing sibutramine in Malaysia.

59


3.0 VARIASI MAKLUMAT PENDAFTARAN

3.1 AKTIVITI

Aktiviti utama Seksyen Variasi adalah menilai permohonan bagi sebarang perubahan maklumat termasuk mengemaskini maklumat produk berdaftar (kecuali produk kosmetik dan veterinar) bagi memastikan keselamatan, keberkesanan dan kualiti produk selepas didaftarkan.

Di antara perubahan-perubahan maklumat produk berdaftar termasuk penambahan maklumat di dalam sisip bungkusan, perubahan pada formulasi produk dan pertukaran tapak pengilangan.

3.0 VARIATION OF REGISTERED INFORMATION

3.1 ACTIVITIES

The main activity of the Variations Section is to evaluate any information change applications, including information updates for registered products (excluding cosmetics and veterinary products), to ensure the safety, quality and efficacy of the product after it has been registered.

These information changes include updating the package inserts, changes to the product formula and change of manufacturing site.

Rajah 29: Permohonan Variasi Yang Diterima Pada Tahun 2010Figure 29: Variation Applications Received in 2010

Supplemen Kesihatan2,429

5%Tradisional

10,012 20%

Bukan Preskripsi8,50317%

Preskripsi28,709

58%

Rajah 30:Permohonan Variasi Yang Diproses Mengikut Kategori Produk (Tahun 2010)Figure 30: Variation Submissions Processed According To Product Category (2010)

30,000

25,000

20,000

15,000

10,000

5,000

0Racun

Ditolak

Dilulus

Bukan Racun Tradisional Supplemen

Kesihatan

18,914

7,662

5,308

2,567

5,125

4,131

9341,199

60



3.2 PENCAPAIAN

Pada tahun 2010, sebanyak 49,653 permohonan variasi telah diterima. Hampir 60% bilangan permohonan tersebut adalah daripada produk-produk preskripsi (Rajah 31).

Sebanyak 92.3% (45,840) daripada jumlah permohonan yang diterima telah diproses pada tahun 2010. Daripada jumlah ini, sebanyak 30,281 permohonan telah diluluskan manakala sebanyak 15,559 permohonan ditolak. Di antara faktor-faktor yang menyebabkan permohonan ditolak adalah:

a) Pertukaran yang dibuat tidak mematuhi keperluan regulatori,

b) Dokumen yang dikemukakan tidak lengkap,c) Dokumen yang dilampirkan tidak berkaitan dengan

maklumat yang dikehendaki.

Bilangan permohonan variasi yang telah diterima dari tahun 2008 hingga 2010 adalah konsisten. Peratusan jumlah permohonan yang telah diproses dalam tempoh yang ditetapkan adalah melebihi 90%. Purata bilangan permohonan variasi yang telah diterima bagi tahun 2008 hingga 2010 adalah 26.4% (10,411) lebih banyak daripada tahun 2007.

Peningkatan yang ketara selepas tahun 2007 didorong oleh beberapa faktor seperti arahan-arahan pekeliling

3.2 ACHIEVEMENTS

A total of 49,653 variation applications were received in 2010. Almost 60% of the variation applications were for prescription products (Figure 31).

92.3% (45,840) of the variation applications were processed in 2010. A total of 30,281applications were approved while 15,559 were rejected. The most common factors contributing to the rejection of applications were:

a) The changes applied did not comply with the regulations,b) The documents submitted were incomplete,c) The documents attached were irrelevant to the information

required.

The number of applications received from 2008 to 2010 is consistent. More than 90% of these applications were processed within the time line. On average, the number of variation applications received during 2008 to 2010 is 26.4% (10,411) more than in 2007.

The drastic increase seen after 2007 was due to several factors, such as new circulars issued by the DCA. The DCA

Rajah 31:Permohonan Variasi Yang Diterima dan Diproses Dari Tahun 2006 ke 2010Figure 31: Variation Submissions Received and Processed from 2006 to 2010

Bila

ngan

Num

ber

2006 2007 2008

Diterima

Diproses

2009 2010

29,5

32

39,4

56

49,4

25

50,5

22

49,6

53

28,0

98

35,3

79

44,5

71

46,6

04

45,8

40

60,000

50,000

40,000

30,000

20,000

10,000

0

61


baru yang dikeluarkan oleh PBKD. PBKD mengeluarkan surat pekeliling dari semasa ke semasa dengan arahan terkini di mana tindakan susulannya akan menyebabkan pemegang pendaftaran produk mengemaskini maklumat produk berdaftar melalui Seksyen Variasi. Di antara surat pekeliling PBKD yang menyebabkan peningkatan permohonan variasi ialah:

a) Pelaksanaan penyelarasan label bagi produk supplemen kesihatan.

b) Kenyataan amaran pada label dan sisip bungkusan produk persediaan cecair oral untuk rawatan batuk dan selsema (cough and cold) yang mengandungi antihistamin, antitusif dan dekongestan (sebagai bahan aktif tunggal atau kombinasi).

c) Penambahan nama dan alamat pemegang pendaftaran pada label produk semulajadi dan supplemen kesihatan.

d) Pengisytiharan sumber haiwan pada label produk.e) Pelaksanaan konsep pek saiz pesakit (patient pack

size) bagi produk farmaseutikal.f) Pemansuhan kenyataan “Diluluskan oleh KKM” pada

label produk ubat-ubatan di pasaran tempatan.g) Penggunaan spesifikasi baru untuk ujian kontaminasi

microbial.

Faktor-faktor lain yang memainkan peranan dalam peningkatan bilangan permohonan variasi adalah tindakan susulan pemegang pendaftaran produk untuk mengemaskini maklumat produk berdaftar setelah mendapat arahan daripada Seksyen Farmakovigilans bagi memasukkan data keselamatan dan arahan daripada Seksyen Surveilans & Aduan Produk bagi mengemaskinikan maklumat-maklumat yang telah diubah oleh pihak pemegang tanpa kelulusan BPFK.

issues circulars from time to time with directives whereby the product registration holders are required to update the product information via the Variation Section. Among the circulars that contributed to the increase of variation applications are:

a) Standardisation of labels for health supplements.b) Warnings of label and package inserts of oral liquids that

contain anti-histamines, anti-tussives and decongestants (as a single active ingredient or combination) for the treatment of cough and colds.

c) Addition of the name and address of the product registration holder onto the labels of traditional products and health supplements.

d) Declaration of animal source on product labels.e) Implementation of patient pack size for pharmaceutical

products.f) Removal of the statement “Approved by MOH” from the

labels of locally marketed medicinal products.g) New specifications for microbial contamination test.

Other factors contributing to the increase in variation applications included directives from the Pharmacovigilance Section to update the safety information as well as directives from the Surveillance and Complaints Section to update the changes that had been made to the product without prior approval from the NPCB.

Rajah 32:Permohonan Pertukaran Tapak Pengilang Yang Diterima Daripada Tahun 2006 ke 2010Figure 32: Change of Manufacturing Site Applications Received from 2006 to 2010

Bila

ngan

2006 2007 2008TahunYear

2009 2010

324

263226

481 450

600

500

400

300

200

100

0

62



Bilangan permohonan pertukaran tapak pengilangan yang diterima pada tahun 2010 ialah 450. Angka ini tidak banyak berbeza berbanding dengan 481 permohonan yang diterima pada tahun 2009. Namun, purata bilangan permohonan yang diterima pada kedua-dua tahun tersebut adalah 106% (240) lebih banyak daripada tahun 2008.

Di antara faktor-faktor yang mendorong kepada peningkatan yang ketara dalam bilangan permohonan pertukaran tapak pengilangan ialah:

a) pemindahan lokasi pengilangan,b) pengembangan lokasi yang sedia ada ,c) percantuman antara syarikat.d) pelantikan pengilang ubat tradisional yang baru

akibat penggantungan lesen pengilang yang lama oleh PBKD.

A total of 450 applications for change of manufacturing sites were received in 2010. This is almost similar to the number of applications (481) received in 2009. On average, the number of applications received during these two years is 106% (240) more than in 2008.

Among the factors contributing to this drastic increase in the number of change of manufacturing site applications include:

a) transfer of premises to a different location,b) upgrading of the current premises,c) mergers between companies,d) appointment of a new traditional medicine manufacturer

due to the suspension of previous manufacturing license by the DCA.

63


4.0 NOTIFIKASI KOSMETIK

4.1 OBJEKTIF

Memastikan semua produk kosmetik bernotifikasi di pasaran mematuhi keperluan perundangan serta memastikan produk kosmetik di pasaran berkualiti dan selamat kepada pengguna.


Aktiviti-aktiviti yang dijalankan di bawah program ini merangkumi:

• proses penyaringan maklumat dan formulasi produk kosmetik bagi memastikan ianya bebas dari bahan terlarang dan semua bahan-bahan yang digunakan adalah dalam had yang dibenarkan,

• pengendalian audit ke atas Fail Maklumat Produk• pensampelan dan pengujian produk untuk ujian kualiti

bagi memastikan produk kosmetik mematuhi piawaian kualiti yang ditetapkan

• semakan label dan tuntutan produk bagi memastikan label dan tuntutan produk mematuhi keperluan pelabelan yang ditetapkan

• pemantauan kesan advers akibat penggunaan produk kosmetik

• audit pengilang kosmetik bagi memastikan produk tersebut dikilangkan oleh pengilang kosmetik yang mempunyai fasiliti yang sesuai untuk mengilang produk kosmetik dan mematuhi keperluan Amalan Perkilangan Baik

• pengendalian aduan orang ramai• pemantauan iklan-iklan produk kosmetik

4.3 PENCAPAIAN

Modul Quest 3 Kosmetik

Modul Quest 3 Kosmetik telah berjaya dilancarkan kepada umum pada bulan Julai 2010 bagi menggantikan modul Quest2 kosmetik yang sediaada. Beberapa penambahbaikan telah dilakukan pada sistem Quest 3 baru ini antaranya penambahan fungsi auto-screening yang mampu menyaring formulasi produk kosmetik yang mengandungi bahan terlarang atau bahan yang melebihi had yang dibenarkan semasa pemohonan notifikasi, penyaringan nama produk yang tidak dibenarkan, kawalan kemasukkan bahan baru dan beberapa lagi penambahbaikan bagi meningkatkan kelicinan sistem notifikasi kosmetik . Sistem Quest 3 juga telah dilengkapi dengan pangkalan data bahan kosmetik yang terkini dan dikemaskini dari semasa ke semasa.

4.0 COSMETIC NOTIFICATION

4.1 OBJECTIVE

To ensure that cosmetic products comply with current regulatory requirements and are of high quality and safe to use.

4.2 ACTIVITIES

Post Market Surveillance activities conducted include:

• screening of the product information and formulation to ensure that it is free from any banned ingredients and that all ingredients are used within the allowed limits

• auditing of product information file (PIF)• sampling and testing of products to ensure that the

products meet the quality standards for cosmetics• checking of product labels and claims to ensure they

comply with the labeling requirements• monitoring of adverse events from the use of cosmetics• auditing cosmetic manufacturers to ensure that the

products are manufactured in manufacturing facilities that are suitable and that comply with Good Manufacturing Requirements (GMP)

• handling of product complaints from the public• monitoring of cosmetic product advertisements

4.3 ACHIEVEMENTS

Quest 3 Cosmetic Module

The Cosmetic Module of the Quest 3 system was officially launched in July 2010 to replace the existing Quest 2 system. Several upgrades had been made with the new system including an auto-screening function which screens the product formula for prohibited ingredients and restricted ingredients exceeding the allowable limit, product names that are not allowed, control of new substances and many other improvements to help the cosmetic notification system run smoothly. The Quest 3 system is also equipped with a new and regularly updated database of cosmetic ingredients.

64



Sistem baru ini juga telah direka bentuk agar ia lebih mesra pengguna dan memudahkan pihak syarikat mengendalikan pengurusan data produk-produk kosmetik yang dinotifikasikan oleh mereka.

Program Kesedaran Pengguna

Seksyen Kosmetik telah terlibat di dalam beberapa program untuk memberi kesedaran kepada pengguna terhadap kawalan produk kosmetik dan penggunaan produk kosmetik secara selamat. Ceramah telah diberikan kepada pengurusan salun kecantikan, ahli-ahli PUSPANITA dan Pegawai farmasi komuniti.

Bilangan produk kosmetik yang bernotifikasi telah meningkat sebanyak 142% dari 37,466 produk pada tahun 2009 kepada 53,262 produk pada tahun 2010.

The new system had been designed to be more user-friendly and allows the industry better data management for their notified products.

Consumer Awareness Programme

The Cosmetics Section had been involved in several programs to promote awareness on control of cosmetics and its safety. The Cosmetics Section had given talks to beauty salon operators, member of PUSPANITA and community pharmacists.

The number of notified cosmetic products had increased by 142% from 37,466 in 2009 to 53,262 product in 2010.

Rajah 34: Pembatalan Notifikasi Produk Kosmetik Tahun 2010Figure 34: Notification Cancellation of Cosmetic Products in 2010

111%

121%

404%

11110%

89884% Penyaringan Formulasi Produk

Screening of Product Formula

Isu GMPGMP Issue

CampurpalsuAdulteration

Produk Bukan KosmetikNon-Cosmetic Products

Lain-LainOthers

Rajah 33: Produk Kosmetik BernotifikasiFigure 33: Cosmetic Notification

2008TahunYear

2009 2010

30,531

37,466

53,262

60,000

50,000

40,000

30,000

20,000

10,000

0

65


Sebanyak 84% pembatalan notifikasi produk kosmetik adalah hasil penyaringan formulasi produk di mana produk-produk tersebut didapati mengandungi bahan terlarang atau bahan yang melebihi had dan syarat dibenarkan. Sejak perlaksanaan fungsi auto-screening pada sistem Quest 3, produk-produk sedemikian dapat dikesan dengan lebih cepat.

Bilangan Fail Maklumat Produk yang diaudit pada setiap tahun telah meningkat dari tahun ke tahun sejak perlaksanaan pada tahun 2008. Seksyen kosmetik lebih aktif memilih produk-produk untuk diaudit dan pihak syarikat pemegang notifikasi lebih memahami keperluan Fail Maklumat Produk dan kepentingan self-regulation.

84% of the cosmetic product notification cancellations were a result of formulation screening. These products were found to contain banned ingredients or ingredients exceeding the allowable limit or requirements. Since the implementation of the Quest 3 auto-screening function, these issues were detected more effectively.

The number of Product Information Files (PIF) audited had increased over the years since its implementation in 2008. There was more active selection of products to be audited and the product notification holders were more aware of the PIF requirements and the importance of self-regulation.

Rajah 35: Audit Fail Maklumat Produk (PIF)Figure 35: Product Information File (PIF) Audit

400

350

300

250

200

150

100

50

0

2008 2009 2010

Fail Maklumat Produk (PFI) Diaudit Product Information Files Audited

12

285

377

66



Rajah 36 menunjukkan bilangan surat kebenaran pengimportan produk kosmetik tanpa notifikasi bagi tujuan market sampling dan in-house evaluation.

Rajah 37 menunjukkan bilangan Sijil Penjualan Bebas yang dikeluarkan kepada syarikat pemegang notifikasi kosmetik bagi tujuan mengekspot produk tempatan.

4.4 PENAMBAHBAIKAN TERHADAP ISU SEMASA

Pada tahun 2010, Pengarah Kanan Perkhidmatan Farmasi (PKPF) telah mengeluarkan dua direktif yang berkaitan produk kosmetik susulan daripada isu keselamatan terhadap produk kosmetik yang dikenalpasti semasa Program Pengawasan Mutu Produk Kosmetik di Pasaran iaitu:

i) Direktif Bilangan 1 Tahun 2010 berkenaan produk kosmetik untuk digunakan pada bahagian sekitar

Figure 36 shows the number of permits issued for the import of cosmetic products without notification for market sampling or in-house evaluation.

Figure 37 shows the number of Certificates of Free Sales issued to cosmetic notification holders for the export of locally manufactured products.

4.4 IMPROVEMENTS ON CURRENT ISSUES

In 2010, the Director of Pharmaceutical Services had issued two directives related to cosmetic products as a result of safety issues that were identified under the Post Market Surveillance Program. These were:

i) Directive “Bilangan 1 Tahun 2010” regarding cosmetic products used around the eye area and packaging not

Rajah 36: Market Sampling dan In-house EvaluationFigure 36: Market Sampling and In-house Evaluation

Rajah 37: Sijil Penjualan Bebas (CFS)Figure 37: Certificate of Free Sales (CFS)

7,000

6,000

5,000

4,000

3,000

2,000

1,000

0

2008 2009 2010

Permit “Market Sampling” dan “In-house Evaluation” DikeluarkanMarket Sampling dan In-house Evaluation Issued

5,7436,024

4,482

2,000

1,950

1,900

1,850

1,800

2008 2009 2010

Bilangan CFS dikeluarkanCFS issued

1.1671,936

1,913

67


luaran mata dan jenis pembungkusan yang tidak dibenarkan untuk produk tersebut.

- Direktif ini dikeluarkan susulan daripada laporan dan aduan yang diterima berkenaan penjualan produk-produk untuk kegunaan pada bahagian sekitar luaran mata seperti produk toner mata yang pada asalnya dinotifikasikan sebagai produk kosmetik untuk digunakan sebagai pelembap sekitar mata tetapi telah disalahgunakan untuk dititis atau disembur ke dalam mata dengan tuntutan untuk tujuan rawatan dan perubatan.

- Produk tersebut tidak lagi dikelaskan sebagai produk kosmetik dan status notifikasi produk tersebut telah dibatalkan.

- Produk kosmetik untuk digunakan di sekitar luaran mata tidak dibenarkan dibungkus di dalam bekas yang berupa botol ubat titis mata (eye drop bottle) atau bentuk semburan (spray) bagi mengelak produk-produk tersebut disalahguna untuk dititis atau disemburkan ke dalam mata.

ii) Direktif Bilangan 2 Tahun 2010 berkenaan produk untuk digunakan pada bahagian alat kelamin/genital lelaki atau wanita bagi tujuan rangsangan seksual lelaki atau wanita tidak dikelaskan sebagai produk kosmetik

- Direktif ini dikeluarkan susulan dari laporan dan aduan berkenaan penjualan produk-produk untuk disapu pada bahagian alat kelamin/genital lelaki atau wanita yang pada asalnya dinotifikasikan sebagai produk kosmetik untuk digunakan sebagai pelembap kulit bahagian alat kelamin/genital lelaki atau wanita tetapi telah disalahgunakan untuk tujuan rawatan seksual lelaki atau wanita.

- Produk-produk untuk disapu pada bahagian genital lelaki atau wanita tanpa bilas (leave-on product) TIDAK DIKELASKAN sebagai PRODUK KOSMETIK kerana bimbang berlakunya salahguna produk tersebut untuk tuntutan dan iklan yang melampaui takrifan kosmetik dan keselamatan produk untuk digunakan pada bahagian sulit lelaki atau wanita juga tidak diketahui.

allowed for such products.

- This directive was issued following reports and complaints received regarding the sale of products such as eye toners that were originally notified as cosmetic products to moisturise the eye area but were misused as eye drops or sprayed into the eyes for treatment and medicinal purposes.

- These products are not classified as cosmetic products and their product notifications were cancelled.

- Cosmetic products to be used around the eye area are not allowed to be packaged in eye drop bottles or sprays to avoid the use of these products as eye drops or sprays.

ii) Directive ”Bilangan 2 Tahun 2010” regarding cosmetic products used on the male or female genital area for the purpose of sexual stimulation of men or women is not classified as cosmetic products.

- This directive was issued following reports and complaints received regarding the sale of products that were originally notified to be used as skin moisturiser for the genital area of men or women but were misused for the purpose of sexual treatment.

- Products to be applied on the male or female genital area as leave-on preparations are not classified as cosmetic products and their product notifications were cancelled. These products may be misused due to claims and advertisements that are out of the cosmetic product scope and the safety of the product when used around the male or female genital area is unknown.

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5.0 CABARAN

5.1 SURVEILANS DAN ADUAN PRODUK

Hampir 50% produk yang disasarkan untuk persampelan pada tahun 2010 tidak berjaya disampel atas sebab produk tidak dipasarkan. Ini secara tidak langsung telah menjejaskan keberkesanan Program Pengawasan Mutu Produk Berdaftar/Kosmetik Bernotifikasi kerana ini tidak menggambarkan jumlah sebenar produk berdaftar/bernotifikasi yang berada di pasaran.

Bagi produk kosmetik, pesampelan untuk tujuan pengujian makmal hanya disasarkan kepada produk berisiko tinggi sahaja berbanding dengan bilangan sebenar produk kosmetik bernotifikasi di pasaran kerana kekurangan dari segi infrastruktur dan tenaga manusia.

5.2 FARMAKOVIGILANS

i. Laporan ADR yang Rendah daripada Kalangan Pengamal Perubatan

Pelaporan kesan advers oleh pengamal perubatan terutamanya pihak swasta masih berkurangan walaupun laporan keseluruhan ADR menunjukkan peningkatan.

ii. Laporan ADR Tidak LengkapPenerimaan laporan ADR yang tidak lengkap dengan maklumat-maklumat yang penting bagi melancarkan proses penilaian “causality”. Ini menyebabkan pelapor perlu dihubungi semula bagi memperolehi maklumat tambahan.

iii. Tiada Sistem Pengesan “Signal” ADRTidak terdapat sistem ̀ signal detection’ yang mantap untuk memudahkan langkah-langkah proaktif diambil bagi ubat-ubatan yang mempunyai isu-isu keselamatan dan tindakan pencegahan dapat dilakukan dengan segera. Buat masa ini `signal detection’ dilakukan melalui pemantauan secara manual.

iv. Peningkatan Beban KerjaBilangan laporan ADR yang diterima semakin meningkat sejak beberapa tahun yang lalu. Siasatan perlu dijalankan terutama pada kesan advers yang serius supaya dapat membuat penilaian yang tepat. Dengan peningkatan bilangan laporan dan keperluan untuk menghubungi pelapor bagi memperoleh informasi tambahan, kemampuan dan keupayaan staf BPFK perlu ditingkatkan supaya dapat menangani beban kerja ini.

5.0 CHALLENGES

5.1 PRODUCT SURVEILLANCE AND COMPLAINTS

Almost 50% of the products targeted for sampling for 2010 failed to be sampled due to reason such as the product had not been marketed. This had indirectly affected the effectiveness of Post Marketing Surveilance Program because this did not reflect the actual number of registered products/notified cosmetics in the market.

Due to the lack of infrastructure and manpower, at present only high risk cosmetic products are targeted for laboratory testing, of which this is a relatively small fraction of all notified cosmetic products in the market.


i. Low Incidence of ADR Reporting Among Healthcare Practitioners

Adverse event reports by healthcare practitioners, especially from the private sector, are lacking despite the general increase in the number of ADR reports.

ii. Incomplete ADR reportsADR reports received lack vital information and have hampered the process of causality assessment. The reporter has to be contacted to provide further information.

iii. No ADR Signal Detection SystemInavailability of an efficient ADR signal detection system to facilitate proactive action on medicines with safety issues and to enable the implementation of prompt preventative action. Currently, signal detection is monitored manually.

iv. Increased WorkloadThe number of ADR reports received has consistently increased over the years. Investigations need to be carried out, especially on serious adverse effects, for accurate causality assessment. With the increase in number of reports and the need to contact the reporters to acquire additional information, the capacity of NPCB staff has to be increased in order to handle the workload.

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5.3 VARIASI

i. ASEAN Variation Guideline (AVG)Malaysia telah diberikan penghormatan oleh ASEAN Consultative Committee on Standards and Quality – Pharmaceutical Product Working Group (ACCSQ – PPWG) untuk menerajui dalam perangkaan ASEAN Variation Guideline (AVG). Satu ASEAN Variation Guideline Workshoptelah dianjurkan di BPFK pada 8 – 10 Februari 2010.

Berikutan hasil perbincangan daripada bengkel tersebut, draf yang keempat telah dibentangkan di mesyuarat ACCSQ-PPWG yang berlangsung di Jakarta manakala draf kelima telah diedarkan kepada anggota-anggota negara ASEAN pada akhir tahun 2010. Cabaran adalah untuk membuat kompilasi dari komen-komen yang diterima sebelum persetujuan penuh dapat dicapai.

ii. Modul Variasi dan Pertukaran Tapak Pengilangan Sistem QUEST 3

Dari segi penambahbaikan perkhidmatan yang ditawarkan kepada pemohon, Seksyen Variasi sedang dalam proses memberi input untuk penambahbaikkan modul Variasi dan Pertukaran Tapak Pengilangan melalui sistem QUEST 3 supaya lebih sistematik. Berbanding dengan sistem Quest 2, modul Variasi dalam sistem Quest 3 telah direkabentuk berdasarkan format permohonan mengikut jenis variasi supaya rekod statistik yang tepat dapat diperolehi dan berciri interaktif di mana koresponden akan wujud di antara pemohon dan penilai.

Dijangka pelaksanaan permohonan pertukaran tapak pengilangan secara online melalui sistem QUEST 3 akan mengelakkan kerja tambahan pada pemohon, di samping memastikan aliran proses penilaian permohonan yang lebih lancar.

iii. Skim Yuran Pemprosesan

Selain itu, berdasarkan statistik permohonan variasi dan pertukaran tapak pengilang daripada tahun-tahun yang lepas, Seksyen Variasi kini dalam proses menyediakan kertas kerja ke atas cadangan skim yuran pemprosesan bagi permohonan variasi dan pertukaran tapak pengilangan jenis I.

5.3 VARIATION

i. ASEAN Variation Guideline (AVG)Malaysia was given the honor by the ASEAN Consultative Committee on Standards and Quality - Pharmaceutical Product Working Group (ACCSQ – PPWG) to lead the drafting of the ASEAN Variation Guideline (AVG). An ASEAN Variation Guideline Workshop was organised at the NPCB on the 8th – 10th of February 2010.

Following the consensus of the discussion during the workshop, the 4thdraft of the AVG was presented during the ACCSQ-PPWG in Jakarta. The 5th draft has been circulated to ASEAN Member Statesat the end of 2010. The challenge is to compile the comments received before a consensus can be made.

ii. Quest 3 Variation and Change of Manufacturing Site Modules

The Variation Section continuouslyprovide technical input in the development of the Quest 3 Variation and Change of Manufacturing Site modules to further improve services provided to applicants. The Quest 3 module, in comparison to Quest 2, has been designed based on the type of variation application which will allow the module to generate more accurate statistical reports. An interactive feature available in the system will facilitate correspondence between the applicant and the evaluator.

The use of the online Quest 3 system for Change of Manufacturing Site submission is expected to reduce the workload of the applicants and assist the Variation Section in the evaluation process.

iii. Processing Fees

The Variation Section is in the process of preparing the proposal to impose a fee for variation and Type I change of manufacturing site applications, in view of the statistics of variation and change of manufacturing site applications over the years.

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5.4 CONTROL OF COSMETICS

i. Cosmetic Notification SystemWith the implementation of the cosmetic notification system, products may enter the market more easily. Products of low quality and that do not comply with the notification requirements can only be detected during Post Market Surveillance. Hence, the consumers may potentially come across products of low quality or products that present claims outside of the cosmetic scope.

ii. Notification Holders Lack Technical Knowledge Concerning Product Safety

A number of notification holders lack the technical expertise to conduct safety evaluations on their cosmetic products and knowledge regarding the safety of ingredients in the product formulation.

iii. Cosmetic Products Advertisements Exceeding the Scope of Cosmetic Products

Companies are unaware/lack responsibility when advertising cosmetic products including making unsubstantiated claims exceeding the scope of cosmetics products. This poses as a challenge for NPCB to educate the public so that they do not fall victim to these types of advertisements.

6.0 THE WAY FORWARD

6.1 PRODUCT SURVEILLANCE AND COMPLAINTS

Separate units for handling complaints and conducting surveillance were established to further strengthen activities under the Surveillance and Complaints Section. This was possible through the addition of three new officers.

Surveillance activities will be enhanced so that product related issues can be detected in a more effective manner. Product holders may then take preventive measures to improve the quality of their products, hence reducing the number of product complaints in the long run.

Strengthen product selection in Post Marketing Surveillance with emphasis on traditional products and cosmetics,for efficientdetection of adulteration.

Strengthen alliance with the Pharmacy Enforcement Division to improve PMS activitiesespecially in handling adulteration issues.

5.4 KAWALAN KOSMETIK

i. Sistem Notifikasi KosmetikSusulan daripada perlaksanaan sistem notifikasi produk kosmetik, ianya lebih mudah untuk produk-produk ini berada di pasaran. Produk yang kurang bermutu dan tidak mematuhi keperluan notifikasi dapat dikenalpasti semasa Program Pengawasan Mutu Produk Kosmetik di pasaran. Oleh itu, pengguna berpotensi untuk akses kepada produk yang kurang berkualiti dan produk yang didapati mempunyai tuntutan yang melampaui skop takrifan kosmetik.

ii. Pemegang Notifikasi Kurang Pengetahuan dalam Aspek Teknikal Keselamatan Produk

Pihak pemegang notifikasi juga kekurangan kemahiran teknikal untuk menjalankan penilaian keselamatan terhadap produk kosmetik dan juga pengetahuan berkenaan keselamatan sesuatu bahan di dalam formulasi kosmetik.

iii. Iklan Produk Kosmetik yang Melampaui TakrifanKurangnya kesedaran dan tanggungjawab di kalangan pihak syarikat yang mengiklankan produk kosmetik secara tidak berasas dan melampaui skop takrifan kosmetik. Ia menjadi cabaran kepada pihak BPFK untuk meningkatkan kesedaran di kalangan pengguna agar tidak tertipu dengan iklan-iklan sebegini.

6.0 HALATUJU

6.1 SURVEILANS DAN ADUAN PRODUK

Dalam menangani cabaran semasa dan memantapkan lagi aktiviti, Seksyen Surveilans dan Aduan telah diasingkan kepada dua unit iaitu Unit Surveilans dan Unit Aduan dengan penambahan sebanyak tiga anggota.

Aktiviti surveilans akan dipertingkatkan supaya tindakan pencegahan yang lebih mantap dapat diambil oleh pihak pemegang produk sekali gus dapat mengurangkan aduan-aduan kualiti produk.

Memperkasakan pemilihan produk dalam Program Pengawasan Mutu Produk Berdaftar/Kosmetik Bernotifikasi terutamanya produk kategori tradisional dan kosmetik bagi menangani kes-kes campur palsu dengan lebih efisien.

Jaringan kerjasama bersama Bahagian Penguat Kuasa Farmasi perlu diperkukuhkan dan dimantapkan bagi melancarkan perkhidmatan terutama dalam isu campur palsu.

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6.2 FARMAKOVIGILANS

Laporan Kesan Advers Ubat yang Berkualiti

Usaha berterusan untuk melatih Pegawai Farmasi hospital/klinik kesihatan/institusi dalam meningkatkan mutu laporan kesan advers ubat dan ketepatan penilaian `causality’ (causality assessment) laporan kesan advers.

Pengurangan Risiko Pesakit Terhadap Kesan Advers Ubat

Memantapkan aktiviti berkaitan dengan ‘risk minimisation’ termasuk kajian/penyelidikan melibatkan kesan advers ubat melalui pembentukan Jawatankuasa Pemantauan Klinikal Kesan Advers Ubat (ADR Clinical Monitoring Committee) peringkat kebangsaan.

Meningkatkan Komunikasi Risiko Ubat

Meningkatkan keberkesanan aktiviti ‘risk communication’ bagi memastikan maklumat keselamatan sesuatu ubat itu sampai kepada sasarannya.

6.3 VARIASI

ASEAN Variation Guideline (AVG)

Maklum balas tentang draf AVG kelima telah diterima daripada anggota-anggota ASEAN. Draf kelima yang mengandungi cadangan-cadangan daripada anggota-anggota ASEAN akan dibentangkan pada Mesyuarat ACCSQ-PPWG yang akan berlangsung di Singapura pada tahun 2011. Dijangkakan draf keenam akan diedarkan selepas mesyuarat tersebut.

Modul Variasi dan pertukaran tapak pengilangan Sistem QUEST 3

Seksyen Variasi akan terus berusaha untuk memastikan modul variasi dan pertukaran tapak pengilangan direkabentuk sebagaimana yang dirancangkan. Usaha akan ditumpukan pada pengurangan ralat-ralat teknikal kepada tahap minimum agar kesinambungan proses permohonan daripada pengguna hingga penilaian oleh pegawai penilai berjalan dengan lancar.


Increase the Quality of ADR Reporting

NPCB will continue to train pharmacists in hospitals/health clinics/institutions in the effort to improve the quality of ADR reporting and causality assessment.

Minimise Patient’s Risk of Adverse Events

To strengthen activities related to risk minimisation, such as conducting studies/research related to ADR. A national ADR clinical Monitoring Committee will be established to facilitate this.

Improve Risk Communication

Enhance the effectiveness of risk communication activities to ensure that the safety information of a particular medicine reaches its target.

6.3 VARIATION

ASEAN Variation Guideline (AVG)

The ASEAN Member States have given their feedback regarding the 5th draft of the AVG. This draft along with the suggestions from the ASEAN Members will be presented to the ACCSQ-PPWG Meeting to be held in Singapore in 2011. The 6th draft is expected to be distributed after the Meeting.

Quest 3 Variation and Change of Manufacturing Site Module

The Variation Section will work to ensure that the variation and Change of Manufacturing Site modules will be designed as planned. Efforts will be put in to minimise technical errors to ensure a smooth process flow from the applicant’s submission until evaluation by the evaluator.

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6.4 KAWALAN KOSMETIK

Pesampelan Produk Kosmetik

Bagi meningkatkan keberkesanan Program Pengawasan Mutu Produk Kosmetik Bernotifikasi di pasaran, selain penyampelan rutin terhadap produk pemutih kulit, produk untuk mata, produk untuk bayi dan produk untuk body contour/slimming’, kriteria dan skop penyampelan produk kosmetik akan diperluaskan kepada produk-produk seperti pewarna rambut, produk dengan nama yang mengelirukan seperti breast product , massage product, essential oil product dan lain-lain produk yang berpotensi untuk membuat yang melampaui skop takrifan kosmetik turut disasarkan.

Penilaian Keselamatan Kosmetik

Satu Jawatankuasa Pakar Keselamatan Kosmetik (Cosmetic Safety Expert Committee, CoSEC) akan ditubuhkan pada tahun 2011 yang bertujuan untuk mengukuhkan pengetahuan teknikal, berkongsi maklumat terkini berkenaan bahan-bahan kosmetik termasuk bahan-bahan dari herba tempatan serta membuat keputusan terhadap isu-isu keselamatan bahan-bahan kosmetik.

Jawatankuasa ini akan dianggotai oleh pegawai-pegawai yang mahir dan berpengalaman yang dilantik dari beberapa institusi seperti agensi kerajaan dan bukan kerajaan, akademia, persatuan kosmetik, agensi kerajaan, agensi penyelidikkan dan badan regulatori.

6.4 CONTROL OF COSMETICS

Sampling of Cosmetic Products

The Cosmetics Section routinely sample whitening products, baby products, products used around the eye area and slimming products.To increase the effectiveness of the Post Market Surveillance system, the criteria and scope of product sampling will be broadened to include hair dyes and products with ambiguous, suspicious or misleading names and functions, such as, breast products, massage products, essential oils and other products with the potential to be promoted exceeding the scope of cosmetics.

Cosmetic Safety Expert Committee, CoSEC

A Cosmetic Safety Expert Committee (CoSEC) will be formed in 2011 with the aim to strengthen technical knowledge, share the latest information regarding cosmetic ingredients, including ingredients derived from local herbs, and to make decisions concerning safety issues related to cosmetic products.

The committee will comprise of representatives from the academia, cosmetic associations, government agencies, research agencies and the regulators.


PUSAT KOMPLIANS DAN PELESENANCENTRE FOR COMPLIANCE AND LICENSING

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1.0 SEKSYEN AMALAN PERKILANGAN BAIK (AMP) DAN SEKSYEN KUALITI, PENSIJILAN, PELESENAN & AMALAN PENSTORAN BAIK

1.1 PENGENALAN

Pusat Komplians dan Pelesenan (PKP) bertanggungjawab menjalankan pemeriksaan Amalan Perkilangan Baik (APB) ke atas premis pengilang keluaran berdaftar dan produk kosmetik bernotifikasi dalam memastikan pematuhan pengilang-pengilang tersebut terhadap garis panduan APB semasa. PKP, dengan kerjasama daripada Cawangan Penguatkuasa Farmasi (CPF) Negeri, juga bertanggungjawab memastikan pengimport dan pemborong keluaran berdaftar mematuhi keperluan Amalan Penstoran Baik (ASB) semasa. Pusat ini turut terlibat dalam aktiviti pelesenan premis pengilang, pengimport dan pemborong keluaran berdaftar.

1.2 OBJEKTIF

PKP sentiasa berusaha dalam memastikan keluaran berdaftar dan produk kosmetik bernotifikasi yang dibenarkan berada di pasaran tempatan adalah selamat, berkesan dan berkualiti melalui pemeriksaan APB dan ASB yang dijalankan.


Selain daripada menjalankan aktiviti pemeriksaan APB dan ASB dan juga mengeluarkan Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar, PKP juga menjalankan aktiviti-aktiviti berikut:

• Menilai pelan susun atur premis pengilang keluaran berdaftar dan produk kosmetik bernotifikasi.

• Memberi khidmat nasihat berkaitan pematuhan Amalan Perkilangan Baik (APB) dan Amalan Penstoran Baik (ASB) kepada industri.

• Menganjurkan latihan APB dan ASB kepada industri dan ‘WHO Fellows’.

• Mengeluarkan sijil APB dan mengesahkan salina dokumen-dokumen berkaitan lesen.

• Mengeluarkan senarai tambahan keluaran berdaftar.

• Berkerjasama dengan jabatan-jabatan dan agensi-agensi kerajaan lain termasuk Cawangan Penguatkuasa Farmasi (CPF) Negeri dalam perkongsian maklumat-maklumat berkaitan pengilang, pengimport dan pemborong keluaran berdaftar.

1.0 GOOD MANUFACTURING PRACTICE (GMP) SECTION AND QUALITY, CERTIFICATION, LICENSING & GOOD STORAGE PRACTICE SECTION

1.1 INTRODUCTION

Centre for Compliance and Licensing (CCL) is responsible for the Good Manufacturing Practice (GMP) inspections of manufacturers of registered products and notified cosmetics to ensure manufacturers’ compliance towards the current GMP requirements. CCL, with the assistance of the State Pharmacy Enforcement Division, is also responsible for ensuring the importers and wholesalers of registered products adhere to the current Good Storage Practice (GSP) requirements. In addition, CCL is involved in the licensing of manufacturers, importers and wholesalers of registered products.

1.2 OBJECTIVES

CCL, through the GMP and GSP inspections, strives to ensure that all registered products and notified cosmetics which are approved for the local market are safe and of quality.


Other activities that are carried out by CCL are:

• Evaluation of layout plan of manufacturing premises of registered products and notified cosmetics.

• Providing advice and guidance relating to Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) requirements to the industry.

• Providing GMP and GSP training for the industries and ‘WHO Fellows’.

• Issuance of GMP certificates and endorsement of document copies concerning licensing.

• Issuance of additional lists of registered products. • Co-operating with other government departments

and agencies including the State Pharmacy Enforcement Division in sharing information relating to manufacturers, importers and wholesalers of registered products.

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1.4 PENCAPAIAN

Pemeriksaan Amalan Perkilangan Baik (APB)

Sebanyak 324 pemeriksaan APB yang telah dijalankan pada tahun 2010.

Daripada jumlah ini 244 pemeriksaan rutin yang dijalankan adalah terdiri daripada 100 pemeriksaan premis keluaran tradisional, 85 pemeriksaan premis keluaran kosmetik, 39 premis keluaran farmaseutikal, 13 pemeriksaan premis OTC Eksternal, dan 7 pemeriksaan premis Veterinar.

Manakala bagi pemeriksaan bukan rutin, sebanyak 90 pemeriksaan telah dijalankan. Ianya terdiri daripada 15 pemeriksaan Prapelesenan, 33 Pemeriksaan Awal bagi premis Kosmetik, 4 Pemeriksaan Verifikasi, 5 Lawatan Awal, 6 bagi Pemeriksaan Prapensijilan. Selebihnya terdiri daripada pemeriksaan Prekualifikasi, Luar Negara, Penyiasatan, penyediaan ‘Process Validation’ dan juga pemeriksaan susulan berikutan tahap pematuhan APB lemah pada pemeriksaan yang sebelumnya.

Bilangan pemeriksaan yang dijalankan sejak tahun 2005 ditunjukkan di dalam jadual di bawah:

1.4 ACHIEVEMENTS

Good Manufacturing Practice (GMP) Inspections

In 2010, 324 GMP inspections were carried out.

From this figure, 244 of the inspections were routine inspections. These inspections included 100 traditional medicines manufacturers, 85 cosmetic products manufacturers, 39 pharmaceutical products manufacturers, 13 OTC External products manufacturers as well as 7 inspections for veterinary product manufacturers.

The remaining 90 inspections were non-routine inspections. These consisted of 15 Prelicensing inspections, 33 Initial Inspections for cosmetic manufacturers, 4 Verification Inspections, 5 Initial Visit for Veterinary product manufacturers and 6 Precertification Inspections. The rest of the non-routine inspections comprised of Prequalification Inspection, Overseas Inspection, Investigation Inspection, Process Validation Preparation Inspection, as well as verification inspections due to poor GMP compliance.

The number of inspections carried out since 2005 are shown in the table below:

Rajah 38: Bilangan Pemeriksaan APB, 2005-2010Figure 38: Number of GMP Inspections, 2005-2010

2005

Bila

ngan

Pem

erik

saan

Num

ber o

f Ins

pect

ion

2006 2007 2008 20102009

150

100

50

0

Farm aseutikalPharm aceutical

TradisionalTraditional

KosmeticCosmetic

Lain-lainOthers

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Pemeriksaan Amalan Penstoran Baik (ASB)

BPFK meneruskan usaha untuk menjalankan lebih pemeriksaan ASB ke atas pemborong dan pengimport yang dilesenkan oleh Pihak Berkuasa Kawalan Dadah (PBKD). Sebanyak 89 premis telah diperiksa di Lembah Klang sepanjang tahun 2010 berbanding dengan 60 premis yang diperiksa pada tahun 2009, iaitu peningkatan sebanyak 48% berbanding dengan tahun sebelumnya.

Matlamat utama untuk meningkatkan kaedah penstoran dan pengendalian produk berdaftar dapat dipertingkatkan dengan pengenalan Amalan Pengedaran Baik (AEB) kepada para pemegang Lesen Borong dan Mengimport. Beberapa sesi dialog dan mesyuarat telah dijalankan bersama-sama dengan wakil persatuan industri farmaseutikal dan kosmetik tempatan untuk membincangkan rangka deraf Garis Panduan Amalan Pengedaran Baik (AEB). BPFK turut menerima maklum balas dan cadangan daripada wakil-wakil industri seperti MOPI, CTFA dan DSAM untuk memperbaiki deraf Garis Panduan yang dijangka akan diterbitkan pada tahun 2011.

Antara usaha untuk memperkenalkan garis panduan baru tersebut termasuklah Seminar Amalan Pengedaran Baik (AEB) yang diadakan di Teknologi Park Malaysia pada 11-12 April 2011. Seminar tersebut telah disertai oleh 380 peserta daripada kalangan pemborong, pengimport dan pengilang produk-produk berdaftar dan bernotifikasi tempatan. Selain itu, seminar 2 hari ini juga turut disertai oleh pegawai-pegawai farmasi dari Cawangan Penguatkuasa Farmasi dan juga hospital kerajaan dari seluruh negara.

Pemeriksaan APB Luar Negara

BPFK juga turut menjalankan pemeriksaan APB Luar Negara disamping pemeriksaan APB pada pengilang-pengilang produk berdaftar tempatan bagi memastikan produk import yang didaftarkan adalah sentiasa memenuhi keperluan APB semasa dikilangkan. Sepanjang tahun 2010, sebanyak 16 permohonan pemeriksaan luar Negara telah diterima. Walau bagaimanapun, hanya 1 pemeriksaan luar Negara sahaja yang telah dilaksanakan pada tahun 2010.

Good Storage Practice (GSP) Inspections

Throughout 2010, NPCB continued its effort to carry out more GSP inspections on wholesalers and importers licensed by the DCA. There were 89 premises inspected for GSP within Klang Valley in 2010 compared to 60 inspections in 2009, a 48% increment from the previous year.

The aim to improve the storage and handling of registered products was further enhanced by the introduction of the Good Distribution Practice (GDP). A few dialogs and meetings with associations from local pharmaceutical and cosmetic industries were carried out to discuss on the draft of GDP Guideline. NPCB also received feedback from various industry representatives such as MOPI, CTFA, DSAM to further improve the drafted guideline which was expected to be published in early of year of 2011.

Efforts of introducing the new guideline included ‘GDP seminar’ which was held at Technology Park Malaysia on 11-12 April 2010. It involved 380 participants among wholesalers, importers and manufacturers for pharmaceutical, traditional and cosmetic industries as well as State Enforcement Officers and Hospital Pharmacists.

Overseas GMP Inspections

Apart from conducting inspections on local manufacturers, NPCB also performed overseas inspection actively to ensure that the imported products will be manufactured according to current GMP requirements. In 2010, NPCB had received 16 applications for overseas inspection. However, only 1 inspection was conducted in 2010.

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Pemeriksaan APB terhadap Premis Pengilang Produk Veterinar

Sebanyak 9 pemeriksaan terhadap premis pengilang produk veterinar yang telah dijalankan pada tahun 2010. 5 daripadanya adalah terdiri daripada pemeriksaan Prapensijilan dan selebihnya adalah Lawatan Awal terhadap premis pengilangan produk veterinar.

Penilaian Pelan Susun Atur Premis Pengilang

Sebanyak 23 pelan susun atur premis pengilang telah dinilai dan diluluskan pada tahun 2010 untuk mematuhi keperluan APB semasa. Pelan susun atur yang telah diluluskan tersebut terdiri dari 1 premis bukan racun, 10 premis tradisional, 11 premis Kosmetik, dan 1 premis veterinar.

Pemprosesan Lesen

Pengeluaran Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong Keluaran Berdaftar adalah berdasarkan peruntukan Peraturan 12 dalam Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (Pindaan) 2006. Pada tahun 2010, sebanyak 1618 lesen telah dikeluarkan yang meliputi 264 lesen pengilang, 319 lesen mengimport dan 1035 lesen pemborong (Rajah 39). Ini merupakan satu peningkatan (3.18%) berbanding tahun 2009 yang mana hanya 1568 lesen dikeluarkan.

GMP Inspections for Veterinary Products Manufacturers

A total of 9 inspections for veterinary products manufacturers were conducted in 2010. 5 of them were precertification inspections and the remaining were Initial Visits.

Evaluation of Manufacturer’s Suggested Layout Plan

23 layouts from manufacturers had been evaluated and approved by NPCB in 2010 to ensure that the renovation and development of new manufacturing facilities will always comply to current GMP requirements. These layouts were made up of 1 OTC facility, 10 traditional facilities, 11 cosmetic manufacturing facilities and 1 veterinary premise.

License Processing

Issuance of Manufacturer’s License, Import License and Wholesaler’s License is in accordance to Regulation 12 of Control of Drugs and Cosmetics Regulations 1984 (Revision) 2006. In 2010, a total of 1618 licenses were issued and these consisted of 264 manufacturer’s licenses, 319 import licenses and 1035 wholesaler’s licenses (Figure 39). This is a 3.18% increase in comparison to the total number of licenses issued in 2009.

Rajah 39: Jumlah Lesen Pengilang, Mengimport dan Pemborong dikeluarkan , 2006-2010Figure 39: Number of Manufacturer’s, Import & Wholesaler’s Licenses Issued, 2006-2010

Bila

ngan

Num

ber

2006 2007 2008 20102009

776

576

397 319358336

301 257 264255

9701,063 1,089 1,035

955

1200

1000

800

600

400

200

0

PengilangManufacturer

MengimportImport

PemborongWholesaler

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Senarai Keluaran (Tambahan) Lesen Pengilang/ Mengimport

Sebanyak 480 permohonan untuk memasukkan keluaran berdaftar ke dalam senarai keluaran telah diproses sepanjang tahun 2010. Jumlah keluaran berdaftar yang terlibat adalah sebanyak 1935 (Rajah 40). Senarai keluaran (tambahan) ini dikeluarkan berdasarkan permohonan yang dikemukakan apabila terdapat produk yang baru didaftarkan. Penurunan secara mendadak permohonan senarai keluaran (tambahan) yang diperhatikan pada tahun 2008 berbanding tahun 2007 adalah ekoran pelaksaan sistem notifikasi untuk produk kosmetik.

Penarikan Balik Lesen Pengilang

Peraturan 17(1) Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 (Pindaan) 2006 memberi kuasa kepada Pengarah Kanan Perkhidmatan Farmasi untuk menarik balik lesen pengilang keluaran berdaftar. Pada tahun 2010, terdapat 6 kes penarikan balik lesen lesen pengilang yang melibatkan 3 pengilang farmaseutikal dan 3 pengilang tradisional. 4 lesen pengilang ditarik balik kerana gagal mematuhi keperluan Amalan Perkilangan Baik semasa manakala 3 lesen pengilang ditarik balik kerana didapati mengilangkan produk yang dicampur palsu.

Additional Lists for Registered Products

A total of 480 applications (consisting 1935 registered products) for additional list were processed in the year 2010 (Figure 40). These additional lists were issued based on applications submitted when there are newly registered products. The implementation of cosmetic notification system in 2008 caused a drastic decline in the number of applications from 2007 to 2008.

Revocation of Manufacturer’s License

Under the provisions of sub-regulation 17(1) Control of Drugs and Cosmetics Regulation 1984 (Revision) 2006, the Senior Director of Pharmaceutical Services is authorized to revoke Manufacturer’s License. In 2010, a total of 6 manufacturer’s licenses which consisted of 3 pharmaceutical manufacturers and 3 traditional manufacturers were revoked. 4 of the licenses were revoked due to non-compliance with the current GMP guideline while the remaining were revoked due to adulteration issues.

Rajah 40: Senarai Keluaran (Tambahan), 2006-2010Figure 40: Additional Product List, 2006-2010

Bila

ngan

Num

ber

TahunYear2006 2007 2008 2009 2010

1,36

7

2,57

2

535

445

480

10,3

92

20,5

90

2,60

8

2,55

1

1,93

5

25,000

20,000

15,000

10,000

5,000

0

PemohonanApplications

ProdukProducts

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Sijil Amalan Perkilangan Baik (APB)

Sijil APB dikeluarkan untuk tujuan pengeksportan keluaran berdaftar yang dikilangkan oleh pengilang tempatan sebagai pengesahan tahap pematuhan APB pengilang tersebut. Sepanjang tahun 2010, jumlah sijil APB yang dikeluarkan ialah 603 (Rajah 41). Peningkatan yang dicatatkan ini memberi gambaran yang memberangsangkan dari segi pengeksportan dan pemasaran produk tempatan di luar Negara. Sijil ini adalah untuk agensi regulatori negara-negara seperti Australia, Bahrain, Bolivia, Brunei, Cambodia, Canada, China, Colombia, Egypt, Germany, Hong Kong, India, Indonesia, Mexico, South Africa, Singapore, Thailand, USA dan Zimbabwe.

ICH-GCG ASEAN Training Workshop on ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) & Q10 (Pharmaceutical Quality System)

Pada 26 hingga 28 Julai 2010, Pusat Komplians dan Pelesenan telah menganjurkan “ICH-GCG ASEAN Training Workshop on ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) & Q10 (Pharmaceutical Quality System)”. Objektif utama bengkel ini ialah untuk memberikan kefahaman teknikal dan praktikal berkenaan tiga garispanduan ICH iaitu Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System). Bengkel yang berlangsung selama tiga hari ini telah dihadiri oleh 140 peserta yang terdiri daripada agensi regulatori dan industry farmaseutikal tempatan dan juga negara ASEAN.

Good Manufacturing Practice (GMP) Certificates

GMP certificates are issued for the purpose of exportation of locally manufactured registered products. It endorses that the local manufacturer complies with the current GMP requirements. A total of 603 GMP certificates were issued in 2010 (Figure 41). The rise in the number of GMP certificates issued creates a positive outlook in terms of exportation and sale of local registered products abroad. These certificates are required by the regulatory agencies in countries such as Australia, Bahrain, Bolivia, Brunei, Cambodia, Canada, China, Colombia, Egypt, Germany, Hong Kong, India, Indonesia, Mexico, South Africa, Singapore, Thailand, USA and Zimbabwe.

ICH-GCG ASEAN Training Workshop on ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) & Q10 (Pharmaceutical Quality System)

From 26th to 28th July 2010, the Centre for Compliance and Licensing organised the ICH-GCG ASEAN Training Workshop on ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) & Q10 (Pharmaceutical Quality System). This workshop was attended by 140 participants representing local and ASEAN regulatory agencies as well as local and ASEAN pharmaceutical industries. The main objective of this event was to provide technical and practical knowledge on 3 ICH Guidelines: Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

Rajah 41: Pengeluaran Sijil APB, 2006-2010 Figure 41: Issuance of GMP Certificates, 2006-2010

2010

2009

2008

2007

2006

Tahu

nYe

ar

Bilangan Number

Sijil APBGMP Certi�cate

0 100 200 300 400 500 600 700 800

603

536

507

406

339

80



PIC/S Annual Meeting and Seminar 2010 on “GMP Inspections of Manufacturers of Traditional and Herbal Medicinal Products”

Malaysia telah menjadi hos kepada program tahunan Seminar PIC/S pada tahun 2010. Mesyuarat tahunan dan seminar yang bertajuk “GMP Inspections of Manufacturers of Traditional and Herbal Medicinal Products” telah diadakan pada 8-12 November 2010 di Le Meridien Hotel, Kuala Lumpur.

Seminar tersebut telah dihadiri oleh 93 peserta dari agensi regulatori yang menjadi ahli PIC/S serta pelbagai agensi dan organisasi antarabangsa yang meliputi 36 negara dari seluruh dunia. Antara penyertaan bukan ahli PIC/S yang diterima adalah dari Brunei (DPS), China (SFDA), EDQM, Hong Kong (SAR), Indonesia (BPOM), Iran (MOH), Jepun (PMDA), Laos (FDA), New Zealand (MedSafe), Oman (DGPA), Slovenia (JAZMP), Korea Selatan (FDA), Taiwan (FDA), Thailand (FDA), Ukrain (SIQCM), UNICEF dan juga Amerika Syarikat (USFDA).

Majlis telah berlangsung dengan jayanya serta ianya telah dirasmikan oleh Yang Berhormat Menteri Kesihatan Malaysia, Dato’ Sri Liow Tiong Lai. Turut hadir bersama adalah Pengarah Kanan Perkhidmatan Farmasi Dato’ Eisah A. Rahman yang juga terlibat dalam permohonan BPFK untuk menyertai PIC/S pada tahun 2000-2001 serta menyumbang dalam kejayaan BPFK dalam menyertai PIC/S dengan pantas iaitu tidak melebihi 2 tahun.

Dari 93 peserta yang menyertai seminar tersebut juga adalah penceramah, pengerusi sesi bengkel dan ketua bengkel. Kebanyakkan penceramah adalah terdiri dari agensi regulatori yang menjadi ahli kepada PIC/S, World Health Organisation (WHO), China SFDA, sektor akademik dan juga Persatuan Industri Farmaseutikal Malaysia (MOPI).

PIC/S Annual Meeting and Seminar 2010 on “GMP Inspections of Manufacturers of Traditional and Herbal Medicinal Products”

Malaysia had become the host for PIC/S Annual Meeting and Seminar 2010. The seminar on “The Inspection of Manufacturers of Traditional / Herbal Medicinal Products” was held in Le Meridien Hotel, Kuala Lumpur from 8-12

November 2010.

The seminar was attended by 93 participants from various PIC/S Participating Authorities, non-participating authorities and international organizations from 36 countries. The non participating authorities included Brunei (DPS), China (SFDA), EDQM, Hong Kong (SAR), Indonesia (BPOM), Iran (MOH), Japan (PMDA), Laos (FDA), New Zealand (MedSafe), Oman (DGPA), Slovenia (JAZMP), South Korea (FDA), Taiwan (FDA), Thailand (FDA), Ukraine (SIQCM), UNICEF and Unites States of America (USFDA).

The seminar was officiated by the Minister of Health Malaysia, Dato’ Sri Liow Tiong Lai with the presence of Senior Director of Pharmaceutical Services Division, Dato’ Eisah A. Rahman. Dato’ Eisah A. Rahman was also involved in the PIC/S membership application of NPCB back in 2000-2001 and greatly contributed to NPCB’s rapid accession to PIC/s in 2002 in a record time less than 2 years.

The 93 seminar participants included a number of speakers, session chairpersons and workshop leaders. Most of the speakers were from PIC/S Participating Authorities, the World Health Organisations (WHO), Chinese SFDA, academia and Malaysian Organisation for Pharmaceutical Industry (MOPI).

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Objektif utama seminar tersebut adalah:

• Untuk mempelajari produk ubatan tradisional dan herba dari Negara-negara Asia;

• Untuk mewujudkan kesefahaman yang sama dalam APB terhadap PIC/S Annex 7: Manufacture of Herbal Medicinal Products diantara Negara-negara yang menyertai PIC/S;

• Untuk menyeragamkan perlaksanaan pemeriksaan APB diantara Negara-negara yang menyertai PIC/S dalam pemeriksaan APB pada premis pengilang produk tradisional dan herba supaya boleh mencapai tahap pematuhan APB yang dikehendaki;

• Untuk mengenalpasti penambaikan yang boleh dibuat terhadap PIC/S Annex 7: Manufacture of Herbal Medicinal Products ;

• Untuk mewujudkan Aide Memoir yang dipersetujui diantara Negara-negara yang menyertai PIC/S bagi pemeriksaan APB pada premis pengilang produk tradisional dan herba.

Seminar yang berlangsung selama 2 ½ hari tersebut telah dimulakan dengan beberapa sesi ceramah dan diikuti oleh 4 bengkel pada hari kedua yang membincangkan perkara berkaitan dengan:

• Keperluan-keperluan APB minima terhadap fasiliti dan utiliti bagi pengilangan produk tradisional dan herba.

• Kawalan Kualiti terhadap produk tradisional dan herba.

• ‘Risk Management’ terhadap fasiliti pengilangan produk tradisional dan herba.

• Mewujudkan Aide Memoir yang dipersetujui diantara Negara-negara yang menyertai PIC/S bagi pemeriksaan APB pada premis pengilang produk tradisional dan herba

Tambahan pula, peserta seminar juga menyertai lawatan ke FRIM yang meliputi Taman Botanikal serta Gelleri FRIM. Pada hari terakhir seminar tersebut, kesimpulan dari bengkel dan perancangan masa hadapan bagi PIC/S juga telah dibentangkan kepada semua peserta.

The seminar’s objectives were:

• To learn about traditional/herbal medicinal products from experienced Asian countries;

• To bridge the gap of interpretation of PIC/S Annex 7 (Manufacturing of Herbal Medicinal Products) in order to achieve consistence and similar interpretation of GMP for traditional/herbal medicinal products;

• To harmonise the inspection approaches for PIC/S Participating Authorities;

• To identify necessary improvements of Annex 7 and to establish an Aide-Memoire on the inspection of traditional/herbal medicinal products with the aim of facilitation of the planning and conduct of inspection.

The 2 ½ days seminar started with a series of lectures and presentations followed by 4 workshops on the 2nd day of the seminar dealing with:

• Requirement on manufacturing facilities and utilities for the manufacturing of traditional / herbal medicinal products;

• Quality control on traditional / herbal medicinal products;• Risk Management of traditional / herbal medicinal

products manufacturing facilities;• Necessity for modifying PIC/S Annex 7 and proposal for

the development of an Aide- Memoire for the inspection of traditional / herbal medicinal products.

In addition, the seminar participants had also attended 2 onsite visits at Forest Research Institute of Malaysia (FRIM) covering the Botanical Garden and Main Gallery. During the last day of the seminar, a summary of the workshop as well as future trends were presented.

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1.5 CABARAN

• Tempoh pengeluaran Lesen Pengilang, Lesen Mengimport dan Lesen Pemborong keluaran berdaftar telah dipendekkan kepada 10 hari bekerja.

• Meneruskan usaha ke arah 100% permohonan lesen secara ‘online’ melalui sistem QUEST3.

• Untuk meneruskan usaha untuk membantu dan meningkatkan kefahaman APB di kalangan industri tempatan. Contohnya, mengadakan lebih banyak dialog dan perbincangan dengan syarikat yang lemah dalam pematuhan APB.

• Untuk memantau dan memperkenalkan keperluan APB untuk pengilangan produk veterinary kepada pengilang tempatan menerusi lawatan awal, mesyuarat, perbincangan dan seminar antara pengilang produk veterinary dengan BPFK.

• Untuk sentiasa melatih dan mempertingkatkan ilmu pengetahuan dan kemahiran sejajar dengan kemajuan teknologi dalam industry pengilangan produk farmaseutikal khususnya produk berasaskan bioteknologi.

1.6 HALA TUJU

• Menjalankan pemeriksaan AEB terhadap semua pengimport dan pemborong berlesen dan juga pengimport produk Kosmetik bernotifikasi di seluruh Negara.

• Mengadakan latihan/seminar seperti:

o Latihan Amalan Pengedaran Baik (AEB) untuk Penguatkuasa Farmasi dan juga kepada hospital kerajaan di seluruh Negara.

o Seminar Perlaksanaan Kawalan Regulatori ke atas produk-produk veterinary

o Seminar APB bagi pengilang-pengilang produk tradisional yang lemah

1.5 CHALLENGES

• The duration for issuance of Manufacturer’s, Import and Wholesaler’s Licenses has been shortened to 10 working days.

• To strive towards 100% online license applications through QUEST3 system.

• To continuously facilitate and enhance the understanding of GMP among the local manufacturers. For example, more dialogs and discussion with companies with poor GMP compliance.

• To regulate and implement the GMP requirement for the manufacturing of veterinary products among local manufacturers through initial visits, meetings, discussions and seminars between the veterinary product manufacturers and NPCB.

• To continuously train and improve the GMP auditors’ inspection knowledge and skills in line with advancement of new technology in pharmaceutical manufacturing especially in biotechnology based products.

1.6 THE WAY FORWARD

• To introduce and perform Good Distribution Practice (GDP) inspection on all licensed wholesalers and importers as well as importers for Notified Cosmetic products throughout the country with the assistance from State Pharmacy Enforcement officers.

• To conduct training and seminar such as:

o GDP training to all State Pharmacy Enforcement officers in addition to government hospitals throughout the country.

o Seminar on regulatory control for Veterinary products.

o Seminar on GMP for traditional and health supplements manufacturers that have poor GMP compliance.

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2.0 SEKSYEN PENYELIDIKAN KLINIKAL & KOMPLIANS


• Pengeluaran Lesen Import Percubaan Klinikal (CTIL), Permit Mengilang Produk Tidak Berdaftar (CTX) dan Permohonan Variasi

• Pemeriksaan Fasiliti Kajian :i. Pemeriksaan Good Laboratory Practice (GLP)ii. Pemeriksaan voluntari ke atas Pusat Kajian

Bioekuivalens (BE)• Bertindak sebagai sekretariat kepada Jawatankuasa

Penyelidikan Klinikal Kebangsaan (JPKK)• Terlibat dalam Kursus Good Clinical Practice (GCP)• Pengendalian laporan Suspected Unexpected Serious

Adverse Reaction (SUSAR)

2.2 PENCAPAIAN

Pelesenan: Pengeluaran Lesen Import Percubaan Klinikal (CTIL), Permit Mengilang Produk Tidak Berdaftar (CTX) dan Permohonan Variasi

Pada tahun 2010, Seksyen Penyelidikan Klinikal dan Komplians telah menilai sebanyak 73 protokol baru bagi percubaan klinikal di Malaysia untuk produk farmaseutikal, produk biologikal, produk bioteknologi, vaksin, herbal, supplemen dan lain-lain. Seksyen ini juga telah menilai 6 produk tidak berdaftar yang dikilangkan di Malaysia untuk tujuan kajian bioequivalens. Tambahan pula, terdapat 151 pemohonan variasi yang meliputi tambahan kuantiti produk, tambahan pusat penyelidikan, tambahan atau penukaran pintu masuk pengimportan, penukaran pemohon, pemanjangan tempoh luput produk kajian, tambahan atau penukaran tapak pengilang atau pembungkus, penukaran penyelidik utama, pembaharuan Lesen Import Percubaan Klinikal dan lain-lain.

2.0 CLINICAL RESEARCH & COMPLIANCE SECTION

2.1 ACTIVITIES

• Issuance of Clinical Trial Import License (CTIL), Clinical Trial Exemption (CTX) and Variation Application

• Inspection on test facilities includingi. Good Laboratory Practice Inspectionii. Voluntary inspection on Bioequivalence (BE) Centres

• Functions as the secretariat to the National Committee on Clinical Research (NCCR)

• Playing a role in conducting Good Clinical Practice (GCP) courses

• Handling Suspected Unexpected Serious Adverse Reaction (SUSAR) Reports

2.2 ACHIEVEMENTS

Licensing: Issuance of Clinical Trial Import License (CTIL), Clinical Trial Exemption (CTX) and Variation Application

In 2010, the Clinical Research and Compliance Section had evaluated a total of 73 new protocols for clinical trials in Malaysia including pharmaceutical, biological, biotechnology, vaccine, herbal, health supplements products and others. This section had also evaluated 6 locally manufactured unregistered products for bioequivalence study. In addition, there were 151 variation applications being processed in year 2010. Among the variation applications received were additional quantity, additional trial sites, change or additional entry ports, manufacturer/ repacker, change of investigator, CTIL renewal, and others.

84



Hasil daripada penilaian protokol di atas, terdapat sebanyak 234 lesen import untuk percubaan klinikal, 6 permit mengilang produk tidak berdaftar dan 151 kelulusan permohonan variasi telah dikeluarkan kepada industri farmaseutikal seperti yang ditunjukkan dalam Rajah 42.

Pemeriksaan Fasiliti Kajian

a. Pemeriksaan Good Laboratory Practice (GLP)

Pada 2010, BPFK telah melakukan dua Lawatan Infrastruktur ke atas Fasiliti Kajian bukan klinikal yang dikenalpasti berpotensi memenuhi keperluan pematuhan GLP. Lawatan Infrastruktur yang pertama telah dilakukan ke atas Herbal Medicine Research Centre (HMRC), Institut Penyelidikan Perubatan pada 9 April 2010 manakala lawatan infrastruktur kedua telah dilakukan ke atas Perbadanan Bioteknologi Melaka pada 25 Februari 2010. Objektif lawatan ini adalah untuk mengenalpasti bidang kepakaran, menilai persediaan dan kemudahan Fasiliti Kajian yang telah sediada ke arah pematuhan kepada OECD GLP. BPFK telah melakukan Pra-Pemeriksaan ke atas Environmental Technology Research Centre (ETRC), SIRIM Berhad pada 5 Julai 2010 selepas pihak SIRIM mengemukakan borang permohonan GLP. Tujuan Pra-pemeriksaan dilakukan adalah untuk memastikan Fasiliti Kajian mempunyai sumber dan kepakaran untuk menjalankan kajian GLP.

From these evaluations, 234 CTIL, 6 CTX and 151 variations were issued to pharmaceutical industries as shown in Figure 42.

Facility Inspection

a. Good Laboratory Practice (GLP) Inspection

In 2010, NPCB had conducted two Infrastructure Evaluation and Gap Analysis visits to potential non-clinical Test Facilities. The first visit was conducted atthe Herbal Medicine Research Centre (HMRC), Institute of Medical Research (IMR) on 9th April 2010 and the second visit was to The Melaka Biotechnology Corporation on 25th February 2010. The objectives of the visit were to identify the strength of the existing infrastructure and area of expertise, , to evaluate the readiness of the Test Facility towards GLP compliance and their current achievements in the non-clinical studies. The NPCB had conducted a Pre-Inspection on the Environmental Technology Research Centre (ETRC), SIRIM Berhad on 5th July 2010 following their application made to the Good Laboratory Practice (GLP) Compliance Programme. The purpose of this Pre-Inspection was to verify the capabilities of the facility in undertaking GLP studies.

Rajah 42: Jumlah Pengeluaran Lesen Import Percubaan Klinikal (CTIL), Kebenaran Mengilang (CTX) dan Variasi (2006- 2010)Figure 42: Total Issuance of Clinical Trial Import License (CTIL), Clinical Trial Exemption (CTX) and Variation (2006-2010)

Jum

lah

Peng

elua

ran

Tota

l Iss

uanc

e

400

350

300

250

200

150

100

50

0

277

2006

4

231

2007

2

321

268

2008

4

208

2009

2

257 351 343

234

2010

6

151

CTIL Issuance

CTX Issuance

Variation

85


b. Pemeriksaan Voluntari ke atas Pusat Kajian Bioekuivalens (BE)

BPFK telah menjalankan satu pemeriksaan voluntari ke atas Info Kinetics Sdn Bhd, sebuah pusat kajian bioekuivalens (BE) tempatan pada 26 hingga 28 Oktober 2010. Pemeriksaan ini meliputi aspek klinikal yang mematuhi keperluan prinsip Good Clinical Practice (GCP) dan aspek bioanalitikal yang mematuhi keperluan prinsip Good Laboratory Practice (GLP). Ini merupakan pemeriksaan pertama yang dijalankan oleh BPFK setelah Guidelines for Good Clinical Practice Inspection diluluskan oleh PBKD pada 29 Julai 2010.

Persediaan BPFK selaku Agensi Pemantau Pematuhan Kebangsaan (APPK) untuk Kajian Bukan Klinikal yang Mematuhi GLP

BPFK dengan kerjasama Malaysian Biotechnology Corporation telah berjaya menganjurkan Bengkel Good Laboratory Practice Workshop on Study Director & Quality Assurance (QA), pada 2-3 Ogos 2010 di Hotel Istana Kuala Lumpur. Tujuan bengkel ini dianjurkan adalah untuk meningkatkan pemahaman terhadap peranan dan tanggungjawab Study Director dan Quality Assurance (QA) dalam sesebuah kajian GLP.

Dalam persediaan untuk menghadapai pemeriksaan Mutual Joint Visit (MJV) oleh pasukan OECD GLP, BPFK telah mengambil inisiatif dengan menjalankan satu Pemeriksaan Mock yang diperhatikan oleh pakar OECD GLP dari Norway. Pemeriksaan mock ini telah dijalankan ke atas Environmental Technology Research Centre (ETRC), SIRIM Berhad pada 4-5 Ogos 2010. Tujuan pemeriksaan mock ini adalah untuk menilai kemahiran dan kompetensi inspektor BPFK semasa menjalankan pemeriksaan. Penemuan semasa pemeriksaan telah dibincangkan bersama pakar dan maklumbalas yang positif dan membina telah diterima dari beliau.

Dalam usaha untuk memantapkan lagi Program Pemantauan Pematuhan GLP, BPFK telah menyemak semula kesemua dokumen seperti manual GLP, prosedur-prosedur dan juga borang-borang yang digunapakai. Dokumen baru akan mula digunapakai bermula Januari 2011. Semakan semula dokumen-dokumen GLP ini adalah berdasarkan tatacara operasi piawai sediada dan maklumbalas yang diterima dari pakar OECD GLP semasa pemeriksaan mock.

b. Voluntary Inspection on Bioequivalence (BE) Centre

The NPCB had conducted a voluntary inspection on Info Kinetics Sdn Bhd, a local bioequivalence centre on 26-28 October 2010. The inspection was based on Good Clinical Practice (GCP) on clinical site and Good Laboratory Practice (GLP) principles on bioanalytical site. This is the first inspection conducted by NPCB following the approval of the Guidelines for Good Clinical Practice Inspection by the DCA on 29th July 2010.

The NPCB’s Preparations as the National Compliance Monitoring Authority (CMA) for Non-clinical GLP Studies.

The NPCB had successfully collaborated with The Malaysian Biotechnology Corporation in organising the Good Laboratory Practice Workshop on Study Director & Quality Assurance (QA) on 2-3 August 2010 at Istana Hotel, Kuala Lumpur. The objectives of this workshop was to give a thorough understanding about the roles and responsibility of Study Director and QA in GLP studies.

In preparation for the Mutual Joint Visit (MJV) Inspection by OECD GLP inspection team, the NPCB has taken an initiative to conduct a mock inspection observed by an OECD GLP Expert from Norway. The mock inspection was carried out at the Environmental Technology Research Centre (ETRC), SIRIM Berhad on 4-5 August 2010. Its purpose was to evaluate the competency of the NPCB inspectors while performing inspections. The findings during the mock inspection were discussed and positive feedbacks were received from the expert.

In order to strenghten the NPCB GLP Compliance Monitoring Programme, the GLP Manual, procedures and forms involved had been reviewed accordingly and the use of new documents shall be effective from January 2011. The review of documents were done based on NPCB’s standard operating procedures and the comments received from the OECD GLP expert during the mock inspection.

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BPFK bersama-sama STANDARDS MALAYSIA telah menjalankan Siri Latihan Dalaman kepada para Inspektor mereka. Siri latihan ini bertujuan untuk mencapai harmonisasi dalam interpretasi prinsip-prinsip OECD GLP di antara inspektor dari kedua-dua Agensi Pemantau Pematuhan Kebangsaan (APPK).

Bengkel “ASEAN Workshop on MedDRA and Its Application in Safety Drug Monitoring”

Seksyen Penyelidikan Klinikal & Komplians, BPFK telah bekerjasama dengan International Conference on Harmonization (ICH)-Global Coorporation Group (GCG) - ASEAN Collaboration bagi menganjurkan bengkel bertajuk “ASEAN Workshop on MedDRA and Its Application in Safety Drug Monitoring” dari 17-19 Mac 2010 di Le Meridien, Kuala Lumpur. Seramai 50 orang peserta terdiri dari wakil regulatori negara-negara ASEAN dan industri tempatan telah menghadiri bengkel ini. Bengkel ini bertujuan untuk memberi panduan mengenai pemiawaian antarabangsa bagi istilah-istilah yang digunakan dalam farmakovigilans dan pemonitoran keselamatan penyelidikan klinikal.

Jawatankuasa Penyelidikan Klinikal Kebangsaan

Pada tahun 2010, Seksyen Penyelidikan Klinikal dan Komplians bertindak sebagai sekretariat kepada Jawatankuasa Penyelidikan Klinikal Kebangsaan (JPKK) yang dipengerusikan oleh Y. Bhg Tan Sri Dato’ Seri Dr. Hj. Mohd. Ismail Merican, Ketua Pengarah Kesihatan Malaysia. Pada tahun 2010 sebanyak dua mesyuarat telah diadakan iaitu pada 16 Ogos 2010 dan 29 November 2010.

Di samping itu, seksyen ini juga bertindak selaku urusetia kepada Jawantankuasa Kecil Garispanduan Good Clinical Practice. Jawatankuasa tersebut telah mengadakan satu mesyuarat pada 1 Oktober 2010 untuk mengemaskini Malaysia Guidelines for Good Clinical Practice edisi kedua mengikut keperluan semasa. Edisi Ketiga garispanduan dijangka akan diterbitkan pada tahun 2011.

Kursus Good Clinical Practice (GCP)

Sebanyak 23 Kursus GCP anjuran Pusat Penyelidikan Klinikal, Kementerian Kesihatan Malaysia dan Pihak Universiti telah diadakan di seluruh negara pada 2010 di mana Seksyen Penyelidikan Klinikal dan Komplians melibatkan diri dalam memberi ceramah dan pengendalian peperiksaan. Kursus ini diadakan bertujuan untuk memberi pendedahan dan latihan kepada para penyelidik serta kakitangan-kakitangan yang terlibat dalam penyelidikan klinikal tentang aspek-aspek GCP yang dipraktikkan.

NPCB together with STANDARDS MALAYSIA had conducted series of In-House Training for their GLP Inspectors. The trainings were conducted to harmonize the understanding and interpretation among the Compliance Monitoring Authorities (CMAs) inspectors pertaining to Principles of OECD GLP and to exchange views on any GLP issues.

The ASEAN Workshop on MedDRA and Its Application in Safety Drug Monitoring

The Clinical Research & Compliance Section (CRCS), NPCB had collaborated with the International Conference on Harmonization (ICH)-Global Corporation Group (GCG) - ASEAN Collaboration to organise “The ASEAN Workshop on MedDRA and Its Application in Safety Drug Monitoring” on 17-19 March 2010 at Le Meridien Hotel, Kuala Lumpur. There were 50 participants from ASEAN regulatory bodies and local industry who participated in this workshop. It was aimed to provide guidance on international standardization of terminology used in pharmacovigilance and safety monitoring in clinical trial.

National Committee for Clinical Research (NCCR)

In 2010, the CRCS served as the secretariat to the NCCR. The committee is chaired by the Director General of Health Malaysia, Y. Bhg. Tan Sri Dato’ Seri Dr. Hj. Mohd. Ismail Merican. Two meetings were held in the year 2010, which are on the 16th August 2010 and 29th November 2010.

In addition, CRCS had also acted as the secretariat to the Malaysian Guidelines for Good Clinical Practice Committee. A meeting was held by the committee on 1st October 2010 to update the second edition of the Malaysian Guidelines for Good Clinical according to current needs. The third edition of this guidelines is expected to be published in 2011.

Good Clinical Practice (GCP) Courses

A total of 23 courses were organised by Clinical Research Centre (CRC), Ministry of Health Malaysia and Universities in all over the country for the year 2010 where the Clinical Research and Compliance Section played important roles in giving lecture and invigilating the GCP examination. These courses were organised to provide exposures and training on the GCP aspects to all researchers and staffs who were involved in clinical trials.

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Laporan Suspected Unexpected Serious Adverse Reaction (SUSAR)

Sebanyak 2,885 laporan SUSAR telah diterima sepanjang tahun 2010. Laporan ini merangkumi penyelidikan klinikal yang mempunyai Lesen Import Percubaan Klinikal dan dihantar masanya berdasarkan Malaysian Guideline for GCP.

Guideline for GCP Inspection

Guidelines for GCP Inspection edisi pertama telah berjaya diterbitkan dan dimuatnaik ke laman web BPFK pada bulan Oktober 2010. Garispanduan tersebut merupakan hasil daripada Mesyuarat Jawatankuasa GCP Inspection Programme yang diadakan bersama-sama dengan sponsor, Contract Research Organisation (CRO), penyelidik dan Persatuan Farmaseutikal Malaysia pada 8 Julai 2010. Sehubungan dengan itu, PBKD telah meluluskan garispanduan ini dalam Mesyuarat PBKD yang ke-230 pada 29 Julai 2011.

Pengurangan Tempoh Kelulusan CTIL/CTX

Tempoh penilaian permohonan Lesen Import Percubaan Klinikal (CTIL) dan Permit Mengilang (CTX) kecuali permohonan yang melibatkan produk biologikal, produk advanced therapy dan penyelidikan klinikal First-in-human telah berjaya disingkatkan dari dua bulan hingga ke tidak lebih 30 hari bekerja mulai 1 Julai 2010.

Suspected Unexpected Serious Adverse Reaction (SUSAR) Report

As many as 2,885 SUSAR reports were received by NPCB in year 2010. These reports involved clinical trials that had CTIL and were submitted according to the Malaysian Guideline for GCP.

Guideline for GCP Inspection

The first edition of Guidelines for GCP Inspection had been successfully launched and uploaded in the official NPCB website in October 2010. This guideline was the outcome of the GCP Programme Committee Meeting involving sponsors, Contract Research Organisation (CRO), investigators and Pharmaceutical Association of Malaysia which was held on 8th July 2010. The Drug Control Authority (DCA) had approved the guideline in its 230th meeting on 29th July 2010.

Shortening of The Approval Timelines for CTIL/CTX

The timelines for processing Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) application except for clinical trial involving biological, biotechnology product, advanced therapy product and First-in human clinical trial had been successfully shortened from 2 months to less than 30 working days. This was effective from 1st July 2010.

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2.3 CABARAN

Contract Research Malaysia (CRM) adalah salah satu Entry Point Project (EPP) daripada 6 EPPs yang dikenalpasti dalam National Key Economic Area (NKEA). Antara sasaran yang ditetapkan adalah peningkatan bilangan penyelidikan klinikal di Malaysia ke 800 kajian klinikal menjelang tahun 2020. Dengan sasaran tersebut, pegawai-pegawai penilai di seksyen ini akan mendapati peningkatan permintaan daripada pihak sponsor, Contract Research Organisation (CRO) dan penyelidik untuk menjalankan penyelidikan klinikal dalam bidang-bidang berikut di Malaysia:

a. First In-Human trial atau penyelidikan klinikal fasa 1b. Advanced Therapy Product (ATP)

Kedua-dua fasa ini mencabar kompetensi serta kepakaran pegawai penilai dalam menilai data-data yang dikemukakan. Maka, pegawai penilai hendaklah diberi latihan dalam bidang-bidang yang kompleks tersebut bagi memastikan jaminan kualiti dan keselamatan produk. Kemahiran penilaian seseorang pegawai boleh dimantapkan melalui latihan dengan badan-badan regulatori yang berpengalaman seperti EMEA, USFDA, Australian TGA dan sebagainya. Dengan ini, Malaysia dapat menarik lebih banyak pelaburan dari sponsor untuk menjalankan kajian percubaan klinikal di samping merealisasikan Malaysia sebagai hub kajian klinikal di rantau ini.

Cabaran yang dihadapi oleh BPFK adalah untuk membantu Malaysia mencapai status pematuhan penuh kepada Sistem Mutual Acceptance of Data (MAD) menjelang akhir tahun 2011. Untuk menjadi non-OECD member adhering to MAD system, BPFK perlu dinilai oleh pasukan OECD GLP semasa pemeriksaan Mutual Joint Visit (MJV). Pemeriksaan ini melibatkan penilaian Program Pemantauan Pematuhan GLP BPFK dan pemerhatian ke atas pemeriksaan Fasiliti Kajian yang dijalankan oleh inspektor-inspektor BPFK. BPFK menghadapi cabaran untuk memastikan Program Pemantauan Pematuhan GLP BPFK memenuhi keperluan OECD GLP dan memastikan Fasiliti Kajian di Malaysia mematuhi keperluan GLP.

2.3 CHALLENGES

The Contract Research Malaysia (CRM) had been identified as one of the 6 Entry Point Projects (EPPs) in the National Key Economy Area (NKEA). Among the targets set by CRM is to have 800 clinical researches conducted in Malaysia by 2020. With the target, evaluators from CRCS will be facing higher demands and growing interest from sponsors, the Contract Research Organisation (CRO) and investigators to conduct clinical research especially in the following fields in Malaysia:

a. First-in-human trial or commonly known the phase I clinical trial

b. Advance Therapy Product (ATP)

Evaluating the clinical trials mentioned above is very challenging. Thus, evaluators should undergo specialised training in evaluating the quality, safety and efficacy of the innovative products. The manpower capacity building could be attained through attachments with other experienced regulatory authorities such as EMEA, USFDA, Australian TGA and etc. With a more competent regulatory platform, Malaysia will undoubtedly attract more investment in conducting clinical trials; which is integral in the realisation of Malaysia as the regional Clinical Trial hub.

The challenge faced by the NPCB is to assist Malaysia in achieving the status of full adherence to the Mutual Acceptance of Data (MAD) System by the end of 2011. In order to become a non-OECD member adhering to MAD system, the NPCB is subjected for a Mutual Joint Visit (MJV) Inspection by the OECD GLP inspection team. The inspection involves review of the NPCB GLP Compliance Monitoring Programme as well as observation on the Test Facility Inspection by NPCB inspectors. The NPCB is facing a challenge to ensure that its Compliance Monitoring Programme fulfilled the OECD GLP requirements and Test Facilities are compliant with OECD Principles of GLP.

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2.4 HALATUJU

Memandangkan aktiviti-aktiviti yang dijalankan oleh Seksyen Penyelidikan Klinikal dan Komplians semakin berkembang seperti:

a. Penilaian produk kajian bagi produk-produk farmaseutikal, bioteknologi, advanced therapy products, herbal, suplemen kesihatan dan lain-lain.

b. Pemonitoran keselamatan produk kajian yang merangkumi kesemua penyelidikan klinikal yang mempunyai Lesen Import Percubaan Klinikal.

c. Menjalankan pemeriksaan GCP dan GLP ke atas pusat kajian bioekuivalens.

d. Menjalankan pemeriksaan GCP ke atas tapak klinikal, sponsor, Clinical Research Organisation (CRO) dan jawatankuasa etika.

e. Menjalankan pemeriksaan GLP ke atas Fasiliti Kajian bukan klinikal

Oleh yang demikian, Seksyen Penyelidkan dan Komplians akan dinaik taraf menjadi sebuah pusat yang diketuai oleh seorang Timbalan Pengarah pada tahun 2011.

Seksyen Penyelidikan Klinikal dan Komplians berusaha bersungguh-sungguh agar Malaysia mendapatkan status pematuhan penuh terhadap Sistem Mutual Acceptance of Data (MAD) bagi OECD Principles of GLP. Dengan menjadi non-OECD memberadhering to MAD, semua data bukan klinikal yang dijalankan di Malaysia akan diterima pakai oleh negara ahli OECD yang lain. Ini sekaligus menjana perkembangan Malaysia sebagai salah satu pusat kajian bukan klinikal di rantau Asia Tenggara.

Selaras dengan arahan di bawah Peraturan 29, Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984, Bilangan 1 Tahun 2011: Akreditasi pusat-pusat kajian Bioekuivalens (BE) dalam negara dari segi pematuhan terhadap prinsip GCP dan GLP akan mula berkuatkuasa sepenuhnya pada tahun 2012. Lima pusat kajian BE tempatan telah dikenalpasti untuk diperiksa oleh seksyen ini pada tahun 2011. Pusat kajian BE luar negara pula akan mula diperiksa pada tahun 2012.

2.4 THE WAY FORWARD

In consideration of the development and expansion of activities carried out by CRCS in several areas such as:

a. Investigational product evaluation which includes pharmaceutical products, biotechnology products, advanced therapy products, herbal products, health supplements and others.

b. Investigational product safety monitoring which involved all clinical trials that have the Clinical Trial Import License.

c. GCP and GLP inspection on Bioequivalence Study Centers.

d. GCP inspection on clinical sites, sponsors, clinical research organisation (CRO) and ethics committee.

e. GLP inspection on non-clinical Test Facilities

As a result, CRCS will be promoted into a centre led by a Deputy Director in 2011.

NPCB is committed to achieve full adherence to the Mutual Acceptance of Data (MAD) System of OECD GLP. By being a non-OECD member adhering to the MAD, all non-clinical data produced in Malaysia will be accepted in other member countries. This will eventually boost up Malaysia as one of the non-clinical studies hubs in Southeast Asia.

A directive has been issued under Regulation 29, The Regulation for Control of Drug and Cosmetic 1984, Number 1 2011: Accreditation for local bioequivalence (BE) centres in terms of compliance with GCP and GLP will be fully enforced in 2012. Five local BE centers have been identified for BE inspection by this section in 2011. The inspection for foreign BE centers will commence in 2012.


PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT


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1.0 PENGENALAN

Menyedari kepentingan komunikasi dalaman dan luaran, BPFK meneruskan usaha dan kerjasama yang erat dengan industri tempatan, persatuan industri, pakar perubatan, anggota akademik, pengguna serta beberapa pihak lain yang berkaitan untuk memantapkan lagi keberkesanan sistem regulatori di Malaysia.

2.0 OBJEKTIF

• Sebagai sumber maklumat ubat-ubatan/produk kepada pegawai yang terlibat dalam penilaian ubat-ubatan/produk dan juga kepada anggota yang terlibat dalam penjagaan kesihatan pesakit untuk penambahbaikan mutu perkhidmatan kesihatan dalam negara.

• Memastikan maklumat yang dipaparkan di laman web BPFK adalah terkni.

• Memantau sistem rangkaian komputer BPFK dan memastikan sistem pendaftaran secara online (QUEST 3) berjalan dengan lancar.

• Memberi penerangan mengenai kaedah pendaftaran produk dan lain-lain yang berkaitan dengannya seperti status pendaftaran (untuk produk farmaseutikal, traditional & kosmetik) serta lain-lain maklumat sepertimana dikehendaki oleh pelanggan.

• Menganjurkan program pendidikan kepada pegawai profesional dan orang awam melalui aktiviti pameran.

• Menyelaras latihan untuk pegawai-pegawai BPFK.• Menjaga dan menyelaras dokumentasi serta

aktiviti yang berkaitan dengan ISO.


• Pengurusan sistem teknologi maklumat• Pengurusan laman web BPFK• Pengurusan pertanyaan• Penerbitan majalah mengenai polisi PBKD (Berita

Ubat-ubatan) dan Laporan Tahunan BPFK. • Pengurusan sesi dialog dengan pihak industri • Kursus dan latihan• Pengurusan lawatan pelawat tempatan dan

antarabangsa

1.0 INTRODUCTION

Noting the importance of both internal and external communications, NPCB continues to work closely and collaborate with local industry, industry associations, health professionals, academia, consumers as well as other stakeholders. This is mainly with the aim to further enhance the overall effectiveness of the regulatory system in Malaysia.

2.0 OBJECTIVES

• Responsible in providing product/drug information to officers involved in product evaluation and also to those who are involved in patient care to provide the best service to the public.

• Ensure only updated information is found on the NPCB website.

• Monitor NPCB’S computer system and to ensure that the online registration system (QUEST 3) functions smoothly.

• Responsible in providing information on product registration procedures and other relevent matters such as registration status (for pharmaceutical, traditional, and cosmetic products) and other information which is required by the public.

• Organise education programes for professionals and public through exhibition activity.

• Coordinate training for the officers.• Coordinate documentation and activity related to

ISO.


• Management of the Information Technology (IT) System

• Maintenance of NPCB website• Handling of enquiries • Publications of magazine related to DCA policies

(Berita Ubat-ubatan) and the NPCB Annual Report• Co-ordinating dialogues with the relevant industry

associations • Trainings and Courses• Handling local and international visitors

PUSAT PEMBANGUNAN ORGANISASICENTRE FOR ORGANISATIONAL DEVELOPMENT

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4.0 PENCAPAIAN

Pengurusan Sistem Teknologi Maklumat

Seksyen Teknologi Maklumat telah berusaha secara berterusan untuk memastikan kelancaran Sistem QUEST 3. Langkah-langkah yang diambil untuk mencapai kelancaran tersebut termasuk meletakkan Unit IT di PPO yang berfungsi untuk memantau system komputer serta ‘Help-Desk’ yang diselia oleh BPFK sendiri. Ini membolehkan penyelesaian masalah dibuat dengan lebih sempurna dari segi penyampaian masalah yang dihadapi pengguna dan penyelenggaraan system oleh pihak vendor.

Pengurusan Laman Web BPFK

Sebarang pembaharuan dan maklumat terkini untuk memudahkan kerja regulatori seperti garispanduan sentiasa disemak semula. Dokumen ini dipaparkan dan sedia dimuat turun dari laman web rasmi BPFK (www.bpfk.gov.my).

Pengurusan Pertanyaan

PPO memainkan peranan yang penting dalam memberi maklumat am kepada pengguna dan industry. Sebanyak 3,062 Pertanyaan telah diterima oleh PPO pada tahun 2010 di mana terdapat peningkatan sebanyak 15% berbanding tahun sebelumnya (Rajah 43). Peningkatan ini disebabkan oleh pengenalan sistem QUEST 3 di dalam sistem pendaftaran produk.

4.0 ACHIEVEMENTS

Management of the Information Technology (IT) System

The ICT Section had put in relentless efforts to ensure the smooth running of the QUEST 3 System. This included the establishment of a dedicated IT Unit within NPCB which oversees the computer system as well as a Helpdesk within NPCB (to ensure better monitoring of problems encountered by customers), outsourcing of maintenance and troubleshooting.

Maintenance of the NPCB Website

Several new/updated articles such as guidelines to facilitate regulatory matters were revised and developed. The adopted documents are downloadable from the official NPCB website (www.bpfk.gov.my).

Handling of Enqueries

Centre for Organisational Development plays an important role in supplying general information to consumers and industries. A total of 3,062 enquiries had been received by the centre in 2010. An increase of 15% (Figure 43) was seen compared to 2009 which could be attributed to the introduction of QUEST 3 system in product registration.

Rajah 43: Bilangan Pertanyaan Diterima (2006-2010)Figure 43: Number of Enquiries Received (2006-2010)

4,000

3,500

3,000

2,500

2,000

1,500

1,000

500

0

2006 2007 2008 2009 2010

3,663

1,731

2,322

2,607

3,062

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^^ Bilangan pertanyaan bagi kategori selain walk-in tidak dapat dikemukakan kerana data tidak dapat diasingkan daripada jumlah pertanyaan

Penerbitan

Pada tahun 2010, 4 edisi Berita Ubat-ubatan yang mengandungi berita dan polisi terkini PBKD dan 1 naskah Laporan Tahunan BPFK telah diterbitkan untuk edaran.

Pengurusan Sesi Dialog dengan Pihak Industri

BPFK bekerjasama erat dengan pihak industri tempatan, persatuan industri, pakar perubatan, golongan akademik, pengguna dan pihak-pihak yang berkaitan bagi memastikan keberkesanan sistem regulatori yang digunapakai. Sehubungan dengan itu, pihak BPFK kerap menganjurkan mesyuarat kumpulan kerja teknikal (technical working group, TWG) dan dialog dengan pihak industri yang mengikut keperluan. Sebanyak 8 sesi dialog telah berjaya dianjurkan sepanjang tahun 2010 iaitu dialog dengan Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI), Cosmetic, Toiletry and Fragrance Association Malaysia (CFTA), Persatuan Edaran Terus Malaysia, Majlis Perubatan Homeopathy Malaysia (MPHM), Malaysia Dietary Supplement Association (MADSA), Penguatkuasa Farmasi (BPF) dan Malaysian Development Institute (MDI).

Kursus dan Latihan

PPO sering menganjurkan pelbagai ceramah, bengkel dan seminar untuk anggota BPFK. Program Continuous Professional Development (CPD) dianjurkan bagi pegawai farmasi dan pembantu farmasi sebagai sebahagian daripada program latihan yang dikendalikan oleh PPO.

^^ The number of queries for other categories (besides walk-ins) could not be presented as the data was not listed separately from the total number of queries

Publication

In 2010, 4 editions of the Drug Control Authority (DCA) bulletin i.e Berita Ubat-ubatan (containing news and updated policies of the DCA) and 1 edition of NPCB Annual Report were published.

Coordinating Dialogues with the Relevant Industry Associations

The NPCB works closely and collaborates with the local industry, industry associations, health professionals, academia, consumers and other stakeholders to further enhance the effectiveness of the comprehensive regulatory system currently in place. In line with this, NPCB frequently plans and organises meetings, technical working groups (TWG) and dialogues with the relevant industries when necessary. A total of 8 dialogue sessions were held in the year 2010 including dialogues with Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI), Cosmetic, Toiletry and Fragrance Association Malaysia (CFTA), Malaysia Direct Distribution Association (MDDA), Malaysian Homeopathic Medical Council, Malaysia Dietary Supplement Association (MADSA), Penguatkuasa Farmasi (BPF) and Malaysian Development Institute (MDI).

Training and Courses

The Continuous Professional Development (CPD) Programme for pharmacist and assistant pharmacists is part of the training programme under the purview of this centre. In 2010, NPCB organised a total of 103 CPD sessions which encompassed educational talks, workshops, Journal Club Sessions as well

Tahun/ YearJenis pertanyaan/ Type of Queries

2006^^ 2007^^ 2008^^ 2009 2010

Telefon/ Phone - - - 1,273 1,696

E-mel/ Email - - - 1,183 1,228

Pertanyaan walk-in/ Walk-in 636 267 337 151 134

Faks & surat/ Fax & Letter - - - 0 4

JUMLAH/ TOTAL 3,663 1,731 2,322 2,607 3,062

Jadual 5: Bilangan dan Kategori Pertanyaan yang Diterima (2006-2010)Table 5: Number and Types of Enquiries Received (2006-2010)

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Pada tahun 2010, BPFK telah menganjurkan sebanyak 103 sesi CPD yang terdiri daripada ceramah, bengkel, kelab jurnal dan seminar. BPFK juga turut menghantar anggotanya menghadiri kursus yang berkaitan di bawah anjuran pihak kementerian serta pihak luar.

Lawatan Pelawat Tempatan dan Antarabangsa

Sebagai satu-satunya badan regulatori di Malaysia yang merupakan WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, BPFK sering menyediakan latihan berkaitan kawalan kualiti farmaseutikal dan system regulatori kepada pelawat. Sepanjang tahun 2010, pihak BPFK telah menerima kunjungan 136 pelawat tempatan dan 23 kunjungan pelawat dari luar negara, antaranya dari Singapura, Maldives, India, Taiwan, Hong Kong, Ireland, Botswana, Tanzania dan Nigeria.

Kursus-kursus yang disediakan diatur secara spesifik untuk memenuhi keperluan pelawat luar Negara dan bidang yang ingin dipelajari pelawat berkenaan. Latihan-latihan lain yang jalankan termasuk latihan dalam analisis, pendaftaran produk generik, farmakovigilans, surveilans, amalan perkilangan baik dan pelesenan.

^: Bagi tahun 2006 aduan QUEST 2 dipantau dalam kategori Pertanyaan #: Unit Pameran diwujudkan pada tahun 2007

as seminars. Many NPCB staffs were also sent for relevant training sessions organised by other parties/ organisations/agencies.

Visits by Local and International Visitors

As the only WHO Collaborating Centre for Regulatory Control of Pharmaceuticals in Malaysia, the NPCB continues to provide training in pharmaceutical quality assurance and regulatory affairs. In 2010, the NPCB had received 136 local visitors and 23 international visitors from countries such as Singapore, Maldives, India, Taiwan, Hong Kong, Ireland, Botswana, Tanzania and Nigeria.

The courses provided were designed specifically to fulfil the needs of the individual fellows. For example, training in pharmaceutical analysis, product registration, pharmacovigilance, surveillance, good manufacturing practice and licensing system.

^: In 2006, the Complaints for QUEST 2 were monitored under Queries#: The Exhibition Unit was formed in 2007

Tahun/YearAktiviti/Activities 2006 2007 2008 2009 2010

Pembangunan QUEST 3QUEST 3 Development

- - √ √ √

Penyelesaian Aduan QUEST 2^Handling of Complaints for QUEST 2^

- 1,204 1,825 1,715 2,091

Pelawat Dalam NegaraLocal Visitors

195 228 66 170 132

Pelawat Luar NegaraInternational Visitors

68 65 24 114 23

Pengendalian LatihanTraining (CPD)

51 57 71 92 103

PenerbitanPublication

4 4 4 4 4

DialogDialogue

5 6 5 6 8

Pameran#

Exhibition# - - 3 4 2

Jadual 6: Aktiviti Pusat Pembangunan Organisasi (2006-2010)Table 6: Activities of the Centre of Organisational Development (2006-2010)

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5.0 CABARAN

Pelaksanaan sistem QUEST3 untuk menggantikan sistem QUEST2 menandakan peningkatan dalam tatacara pengurusan. Hasilnya, beberapa cabaran telah wujud selaras dengan pelaksanaan QUEST3. Misalnya, orang ramai dikehendaki menyesuaikan diri dengan sistem baru dan perlu dilatih serta dididik tentang cara penggunaan QUEST3. Selain itu, sistem QUEST3 masih belum lagi berfungsi dengan sepenuhnya atas sebab proses penghijrahan data yang mengambil masa. Di samping itu, sistem tersebut belum lagi stabil dari segi teknikal.

PPO juga menghadapi cabaran dalam mengemaskini laman web rasmi BPFK. Kemaskini laman web tersebut memerlukan usaha berterusan seperti status terkini QUEST3, berita dan pengumuman penting. Selain itu, PPO perlu memastikan bahawa ciri-ciri laman web seperti link dan search engine dapat berfungsi dengan sepenuhnya.

Akhir sekali, kebanyakan kakitangan di pusat agak baru dan muda. Oleh itu, kekurangan pendedahan dan pengalaman kerja akan menjadi satu cabaran kepada pusat dalam mengatasi tugasnya.

6.0 HALA TUJU

PPO akan terus berusaha untuk menstabilkan sistem QUEST3 pada tahun 2011. Sebagai contohnya, usaha akan dibuat dengan vendor QUEST3 dalam menghasilkan patches yang dapat dimuat turun dari laman web BPFK. Patches tersebut akan mengelakkan gangguan terhadap penggunaan QUEST3. Secara keseluruhannya, kecekapan sistem tersebut akan ditingkatkan.

Pelbagai bengkel dan latihan yang lebih teratur harus diadakan untuk kakitangan di PPO supaya mereka menjadi lebih mantap dan mendapat lebih banyak pendedahan. Selain itu, penambahan bilangan pegawai kanan amat dialu-alukan bagi membantu dalam pembangunan PPO.

5.0 CHALLENGES

The implementation of QUEST 3 system to replace QUEST 2 system signified an improvement in administration procedure. As a result, few challenges have evolved with the implementation of QUEST3. For instance, the public has to adapt to a new system and has to be trained and educated on how to use the functions in QUEST3. Besides, the new system of QUEST 3 has yet to mature as the function is not fully operational due to the migration of data that takes time to be done. In addition, the system has yet to stabilize technically.

The centre is facing another challenge of updating the official NPCB website. It requires continuous efforts to update the website regularly such as the latest status of QUEST 3, news and important announcements. Moreover, the centre has to ensure that the website is fully functional in areas such as links as well as search engines.

Last but not least, most of the staff at the centre are relatively junior. Thus, the lack of exposure and working experience would prove to be a challenge to the centre in overcoming its tasks.

6.0 THE WAY FORWARD

The centre will strive to stabilize QUEST 3 system in 2011. For instance, efforts will be made with the vendor of QUEST 3 in releasing downloadable patches that will stabilize and avoid interuption of usage of QUEST 3. As a whole, these will increase efficiency of the system.

In order to ensure that the staff at the centre are better equipped and gain more exposure, more structured trainings and workshops should be provided to them. Furthermore, the addition of more senior staff is very much welcomed for their experience are vital to the centre.


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1.0 PENGENALAN

Semua hal berhubung dengan pengurusan kewangan dikendalikan oleh Pusat Pentadbiran yang juga bertanggungjawab dalam pentadbiran am dan tugas-tugas lain yang bukan bidang professional. Pusat Pentadbiran memastikan bahawa semua anggota menikmati upahan gaji bulanan, tuntutan-tuntutan rasmi dibayar dalam tempoh yang ditetapkan dan mengawal peruntukan kewangan supaya sentiasa mencukupi bagi menjamin setiap aktiviti yang dirancang boleh mencapai objektif keseluruhannya.

Tanggungjawab lain untuk Pusat Pentadbiran termasuk:

• Pengawalan aset• Pengawalan keselamatan• Perkhidmatan sumber manusia

2.0 PEMBANGUNAN

Pada tahun 2010, beberapa projek pembangunan dan kerja pengubahsuaian telah dijalankan di BPFK untuk mewujudkan persekitaran kerja yang lebih kondusif.

1.0 INTRODUCTION

All matters pertaining to financial management are conducted by the Centre for Administration which is also responsible for general administration and other non-professional matters. This centre ensures that all emoluments and claims are paid within the stipulated time and oversees if the financial allocations are sufficient to ensure all planned activities achieve their objectives.

Other responsibilities of the Centre for Administration include:

• Asset management• Security matters• Service matters (human resource)

2.0 DEVELOPMENT

In 2010, a number of development projects and renovations were carried out in order to provide a more conducive work environment.

BIL/NO NAMA PROJEK/ PROJECT NAME

1. Pusat Pembangunan Organisasi (PPO)• Mereka bentuk, membekal, memasang, mengujilari dan mentauliah Bilik Latihan ICTCentre of Organisational Development (PPO)• Design, supply, installation, maintenance of ICT Training Room

2. Pusat Kawalan Kualiti (PKK)• Naiktaraf Unit Penyelidikan dan Pembangunan• Naiktaraf Bilik Mesyuarat Bunga RayaCentre of Quality Control (PKK)• Upgrading Research& Development Unit• Bunga Raya Room Upgrade

3. Pusat Pendaftaran Produk (PPP)• Kerja-kerja relocation and modification iaitu pemasangan work station• Naiktaraf/pengubahsuaian Bilik Mesyuarat TerataiCentre of Product Registration (PPP)• Relocation and modification work which included the installation of workstations• Upgrading/renovation of Teratai Room

4. Pusat Pembangunan Organisasi (PPO)• Pengubahsuaian/naiktaraf bilik pejabat di tingkat bawah PPOCentre of Organisational Development (PPO)• Renovation/upgrading of office rooms at Ground Floor,PPO

5. Pusat Komplians Dan Pelesenan (PKP)• Naik taraf bilik latihanCentre of Compliance and Licensing (PKP)• Training room upgrade

6. Pusat Pasca Pendaftaran Produk (PASCA)• Membina ruang pejabat baru bagi Seksyen Farmakovigilans dan Seksyen VariasiCentre of Post Product Registration (PASCA)• New office spacefor Pharmacovigilance Section and Variation Section

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3.0 PERUNTUKAN

Sepanjang tahun 2010, BPFK telah menerima peruntukan sebanyak RM 23,891,870 untuk perbelanjaan Mengurus manakala RM 3,180,895 untuk projek Pembangunan. Pecahan bagi peruntukan tersebut seperti jadual di bawah:

3.0 FINANCIAL STATEMENT

In 2010, NPCB had received an allocation of RM 23,891,870 for Operating Expenditure and RM 3,180,895 for Development Expenditure. The breakdown of the allocation is as follows :

Peruntukan dan Perbelanjaan Mengurus BPFK bagi Tahun 2010NPCB Operating Allocation and Expenditure 2010

Kod Objek/Object Code

Jenis Perbelanjaan/

Expenditure

Peruntukan (RM)/Allocation (RM)

Perbelanjaan (RM)/Expenditure (RM)

Baki/Balance

Asal/Original

Dipinda/Amended

Perbelanjaan Bersih (RM)/

Actual Expenditure (RM)

% (RM) %

10000 EmolumenEmolument

4,637,990 15,475,980 16,637,114.09 107.5 (1,161,134.09) (7.50)

20000 Perkhidmatan & Bekalan

Services & Supply

4,834,555 8,398,890 8,281,013.88 98.6 117,876.12 1.40

30000 Aset (Harta Modal)Asset (Property)

17,000 16,310 16,309.60 100 0.40 -

JumlahTotal

- 9,489,545 23,891,180 24,937,437.57 - (1,043,257.57) -

Peruntukan dan Perbelanjaan Pembangunan BPFK bagi Tahun 2010NPCB Developmen Allocation and Expenditure 2010

Kod Projek/Project Code

Jenis Perbelanjaan/Expenditure

Peruntukan (RM)/Allocation (RM)

Perbelanjaan (RM)/Expenditure (RM)

Baki /Balance

Asal/Original

Dipinda/Amended

Perbelanjaan Bersih (RM)/Actual Expenditure (RM) % (RM) %

00105RMK-9

Latihan & Modal InsanTraining & Human

Resouces15,000 50,000 49,790.00 99.58 210 0.42

00300Radicare

Perkhidmatan Sokongan Hospital

Hospitality Support Service

1,134,834 1,134,834 1,124,748.96 99.11 10,085.04 0.89

00600Farmasi

Pharmacy

Aset (Harta Modal)Asset (Property) 535,482 535,482 528,438.50 98.68 7,043.50 1.32

00800PembaikanMaintenance

Peralatan ICT/ Pembaikan

ICT Property / Maintenance

1,687,076 1,180,580 1,180,579.51 100 0.49 -

01100Peralatan PerubatanPharmacy Property

Aset (Harta Modal)Asset (Property) 20,000 20,000 20,000 100 - -

100



Kutipan hasil BPFK diterima melalui pelbagai bayaran untuk pendaftaran produk, notifikasi kosmetik, perlesenan, perkhidmatan makmal dan bayaran-bayaran yang lain.

NPCB obtained its revenue from various payments for product registrations, cosmetic notifications, licenses, laboratory tests as well as other payments.

Pengkelasan Hasil 2010/ Classes of Revenue 2010Jumlah/ TotalCod/

Code Perkara/ Item

73199 Jualan Bahan CetakSelling of Printed Materials 3,915.00

72499 Proses Perkhidmatan MakmalLaboratory Test 44,800.00

Amalan Perkilangan BaikGood Manufacturing Practice 513,555.00

Lesen BorongWholesale License 436,500.00

71499 Lesen ImportImport License 183,000.00

Lesen Import KlinikalClinical Trial License 120,000.00

Lesen KilangFactory License 253,000.00

Daftar UbatProduct Registration 8,041,200.00

72199

Perakuan PenjualanFree Sale Certificate 239,800.00

Tukar PemegangChange of Holder 331,000.00

Pertukaran Tapak KilangChange of Site 79,000.00

Daftar Ubat EksportExport Product Registration 13,000.00

71999 Bayaran-bayaran LainOther payments 323.42

73999 Jualan-Jualan LainOther sales 36,733.98

74299 Sewa Bangunan (kantin)Rental (canteen) 4,800.00

JUMLAH/ TOTAL 10,300,627.40

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4.0 HALATUJU

Pusat Pentadbiran sentiasa berusaha memberikan perkhidmatan yang terbaik kepada anggota BPFK dan orang ramai selaras dengan garis panduan dan arahan perkhidmatan dan perbendaharaan yang berkuat kuasa.

Di Unit Kewangan misalnya, penambahbaikan dalam urusan pembelian barang-barang dan perkhidmatan dibuat melalui sub modul Pembelian secara Sebut harga dan Tender dalam sistem e-Perolehan. Pengenalan dalam sub modul ini memberi peluang kepada pembekal dan kontraktor untuk memperkenalkan barangan dan perkhidmatan mereka secara atas talian. Sub modul ini juga memudahkan pihak BPFK untuk mengiklankan sesuatu projek pembangunan untuk dilaksanakan di BPFK mengikut spesifikasi yang ditentukan.

Di samping itu, memandangkan bilangan kenderaan pejabat BPFK yang terhad, pembelian kenderaan pejabat juga akan dibuat pada 2011.

4.0 THE WAY FORWARD

The Centre for Administration always seeks to explore the possibilty of improving quality of service rendered to the staff of NPCB and stakeholders in accordance with the guidelines and directives.

For instance, improvement at the Finance Unit in the purchasing of goods and services is done through a new purchasing sub-module known as e-Perolehan. This sub-module is recognized to enable all the suppliers and contractors to present their goods and services online. Besides, it helps the NPCB in promoting new development projects with the specifications needed.

In addition, the lack of official vehicles at NPCB has prompted the plan to purchase more vehicles in 2011.



GALERIGALLERY

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GALERIGALLERYLA

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MIN

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Pharmaceutical Inspection C

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Pharmaceutical Inspection C

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ASEA

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ASEA

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Launching of 5S

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Other V

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AKTIVITI SOSIALSOCIAL ACTIVITIES

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PERSATUAN SURI DAN ANGGOTA WANITA PERKHIDMATAN AWAM MALAYSIA (PUSPANITA)

Pada tahun 2010, En. Selvaraja Seerangam terus menjadi penasihat kepada PUSPANITA cawangan kecil BPFK. Berikutan sokongan padu beliau dan usaha gigih dari pengerusi PUSPANITA cawangan kecil BPFK, Pn. Siti Aida bt Abdullah, persatuan ini terus melangkah maju dalam menjayakan pelbagai aktiviti untuk ahli serta kakitangan BPFK. Sambutan yang hangat telah diterima oleh aktiviti-aktiviti tersebut. Sehingga akhir tahun 2010, bilangan ahli PUSPANITA Cawangan Kecil BPFK adalah seramai 199 orang.

ASSOCIATION OF WIVES AND LADIES OF MALAYSIAN CIVIL SERVICE (PUSPANITA)

Mr. Selvaraja Seerangam continued as the advisor for NPCB PUSPANITA in 2010. With his full support as well as the dedicated commitment from the president of NPCB PUSPANITA, Mdm Siti Aida bt Abdullah, various activities were successfully organised and carried out for its members as well as other NPCB staffs. The responses to these activities were overwhelming. As of December 2010, there were a total of 199 members.

PENGERUSI/PRESIDENT : Mdm. Siti Aida bt Abdullah

TIMBALAN PENGERUSI/DEPUTY PRESIDENT : Mdm. Noorul Akmar bt Mohd Noor

SETIAUSAHA/SECRETARY : Mdm. Narqes bt Mohd Raimi

PENOLONG SETIAUSAHA/ASSISTANT SECRETARY : Mdm. Atikah bt Shaharudin

BENDAHARI/TREASURER : Mdm. Junainah bt Omar

PENOLONG BENDAHARI/ASSISTANT TREASURER : Mdm. Maslinda bt Mahat

AHLI JAWATANKUASA/COMMITTEE MEMBERS : Ms. Khirul Falisa bt Mustafa Ms. Siti Nor Rahizah bt Abd Razak Mdm. Hasniza bt Zaidan Ms. Siti Norehan bt Jaafar Mdm. Fadhilah bt Hasbullah Mdm. Zuraidah bt Zainuddin Ms. Nur Hayati Sakinah bt Che Mazelan Mdm. Lahung Mering Ms. Noni Suliatikah bt Che Yusoff Ms. Jeannie Lee Jing Yi Mdm. Normah bt Ali Mdm. Aminah bt Jaafar Mdm. Maznin bt Abdul Majid

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Tarikh/ Date Aktiviti Tahun 2010/ Activities in 2010

26 January 2010Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 01/10

PUSPANITA NPCB Committee Meeting 01/10

11 February 2010Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 02/10


1 April 2010Mesyuarat Agung Tahunan PUSPANITA Cawangan Kecil BPFK Kali ke-22

22nd Annual General Meeting of PUSPANITA NPCB

7 May 2010Kelas Fardhu Ain Sesi 1/2010

Session 1/2010 of Fardhu Ain Class

21 May 2010Kelas Fardhu Ain Sesi 2/2010

Session 2/2010 of Fardhu Ain Class

26 May 2010Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 03/10


4 June 2010Kelas Memasak 1

Cooking class 1

9 July 2010Kelas Memasak 2

Cooking class 2

16 July 2010Kelas Memasak 3

Cooking class 3

30 July 2010Pasaria PUSPANITA

PUSAPANITA Fair11 August 2010 -

2 September 2010

Tadarus Al-Quran telah diadakan sepanjang bulan Ramadhan

Tadarus Al-Quran during the month of Ramadhan

26 August 2010Ceramah agama bertajuk ‘Uniknya Ramadhan’ oleh Ustaz Hj Azman b Halim

Religious Talk entitled Uniknya Ramadhan by Ustaz Hj Azman b Halim

3 September 2010Majlis Khatam Al-Quran dan Ceramah Agama

Majlis Khatam Al-Quran and Religious Talk

19 October 2010Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 04/10


12 November 2010Ceramah Beauty and Grooming

Beauty and Grooming Talk

2 December 2010Ceramah Gaya Hidup Sihat Melalui Teknik Hidroterapi

Healthy Lifestyle via Hydrotherapy Technique Talk

21 December 2010Mesyuarat Jawatankuasa PUSPANITA Cawangan Kecil BPFK 05/10


116


Badan Kebajikan Kakitangan Islam BPFK (BAKKI)

BAKKI merupakan badan yang ditubuhkan untuk tujuan menjalankan aktiviti kebajikan, pendidikan dan keagamaan untuk anggota beragama Islam di organisasi ini. Badan ini memainkan peranan yang penting dalam memberi ilmu pengetahuan agama kepada kakitangan beragama Islam. Selain itu, BAKKI juga menguruskan tabung kebajikan bagi memberi bantuan kepada ahli yang memerlukannya.

NPCB Muslims Staff Welfare Association (BAKKI)

BAKKI is an association formed to organise various activities related to welfare, education and religion for its members at NPCB. It plays an important role in providing religious knowledge to members. Moreover, BAKKI also manages the welfare fund for its members.


Penyertaan Dalam Aktiviti Antarabangsa & Tempatan Participation in International & Local Events

118



Penyertaan BPFK dalam Aktiviti Antarabangsa 2010/ Participation of NPCB in International Events 2010

Aktiviti/Activity Tarikh/Date Tempat/Venue

Mesyuarat ASEAN untuk Mempromosikan Akses kepada Ubat-ubatan Antivirus dan Vaksin Influenza PandemikASEAN Meeting on Promoting Access to Antiviral Drugs and Pandemic Influenza Vaccines

27-29 January 2010 Singapore

Latihan kakitangan untuk Upgrading of National Health Laboratory(NHL), Pihak Berkuasa Makanan & Dadah MaldivesStaff Training for the Upgrading of National Health Laboratory (NHL), Maldives Food and Drug Authority, Republic of Maldives

20 February – 8 March 2010 Republic of Maldives

Mesyuarat International Regulatory Co-operation for Herbal (IRCH) Working Group – Evidence for Health ClaimsInternational Regulatory Co-operation for Herbal Medicines (IRCH) Workshop – Evidence for Health Claims

8-11 March 2010 Sydney, Australia

Kursus Pemeriksaan Amalan Klinikal BaikGood Clinical Practice Inspection Course 22-26 March 2010 Jakarta, Indonesia

Pemeriksaan Amalan Perkilangan Baik (APB) Premis Pengilang Produk SterilGood Manufacturing Practice (GMP) Inspection on Sterile Products Manufacturing Premises

20-27 April 2010 India

Pemeriksaan Amalan Perkilangan Baik (APB) Premis Pengilang Produk SterilGood Manufacturing Practice (GMP) Inspection on Sterile Products Manufacturing Premises

25-29 April 2010 Shijiazhuang, China

Latihan untuk Pemeriksaan BioekuivalensTraining on Bioequivalence Trial Inspection 5-7 May 2010 Singapore

Bengkel AHC 2010 – Globalisasi dalam Rangkaian Bekalan FarmaseutikalAHC 2010 Workshop – Globalization in the Pharmaceutical Supply Chain

12-14 May 2010 Seoul, Korea

Mesyuarat Jawatankuasa Pharmaceutical Inspection Cooperation Scheme (PIC/s)Pharmaceutical Inspection Cooperation Scheme (PIC/s) Committee Meeting

17-20 May 2010 Geneva, Switzerland

Forum Pakar Hati dan Ginjal Serantau Ke-55th Regional Expert Forum on Liver and Kidney 20-23 May 2010 Phnom Penh, Cambodia

WHO-Uppsala Monitoring Centre (UMC)-Pihak Berkuasa Sains Kesihatan-Kursus Latihan FarmakovigilansWHO-Uppsala Monitoring Centre (UMC)-Health Sciences Authority (HSA)-Basic Pharmacovigilance Training Course

31 May – 4 June 2010 Singapore

Mesyuarat Tahunan International Regulatory Co-operation for Herbal Medicines (IRCH) Ke-44th Annual Meeting of International Regulatory Co-operation for Herbal Medicines (IRCH)

8-10 June 2010 Dubai, United Arab Emirates

Mesyuarat ASEAN Cosmetic Committee (ACC) ke-14 dan Mesyuarat ASEAN Cosmetic Scientific Body (ACSB) ke-1314th ASEAN Cosmetic Committee (ACC) & 13th ASEAN Cosmetic Scientific Body (ACSB) Meetings

8 - 11 June2010 Jakarta, Indonesia

Penyertaan Dalam Aktiviti Antarabangsa & TempatanParticipation in International & Local Events

119



Mesyuarat Koordinasi untuk Projek RAS Serantau 2013: Amalan Radiofarmasi Baik dan APBFinal Coordination Meeting of the Regional Project RAS 2013: Good Radiopharmacy Practice and GMP

5-9 July 2010 Jakarta, Indonesia

Mesyuarat ke-17 ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG)The 17th ASEAN Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG) Meeting

20–23 July 2010 Yogyakarta, Indonesia

Mesyuarat ke-13 Traditional Medicines and Health Supplements Product Working Group13th Traditional Medicines and Health Supplements (TMHS) Product Working Group Meeting

26-30 July 2010 Hanoi, Vietnam

Kursus Latihan untuk Penilaian Laporan Kajian Bioavailability/ Bioequivalence dalam Aplikasi UbatTraining Course on Evaluation of Bioavailability/ Bioequivalence Study Report in a Drug Application

29-30 July 2010 Hanoi, Vietnam

Persidangan Annual Open Forum on Key Issues in Tuberculosis Drug DevelopmentKe-44th Annual Open Forum on Key Issues in Tuberculosis Drug Development

18-19 August 2010 Addis Ababa, Ethiopia

Bengkel WHO/Pihak Berkuasa Makanan dan Dadah Korea (KFDA): Implementasi Garispanduan WHOWHO/Korea Food and Drug Administration (KFDA) Workshop: Implementing WHO Guidelines

24-26 August 2010 Seoul, Korea

Program Adverse Experience Reportinguntuk Produk VeterinarAdverse Experience Reporting Program for Veterinary Products 19-27 August 2010

Australian Pesticides & Veterinary Medicines Authority, Australia

Bengkel Kajian Klinikal Multi-Regional Seoul 20102010 Multi-Regional Clinical Trials Seoul Workshop 13-15 September 2010 Seoul, Korea

The World Pharma Trials Asia 2010 13-16 September 2010 Shanghai, ChinaBengkel GHS Stocktaking untuk Asia Tenggara, Asia Timur & Asia TengahGHS Stocktaking Workshop For Southeast, East & Central Asia 15 – 17 September 2010 Beijing, China

17th PIC/S Expert Circle on Human and Blood Tissue 28 September 2010 Saint-Denis, FranceLatihan APB untuk Pengeluar Vaksin – Keperluan Regulatori Semasa & ImplementasiTraining on GMP for Vaccine Manufacturers – Current Regulatory Requirements & Practical Implementation

13-15 October 2010 Heidelberg, Germany

Expo Perubatan Tradisional 2010Traditional Medicine Expo 2010 15 October 2010 Singapore

WHO Qualified and Biopharmaceutical Facility 18-22 October 2010 Goa, IndiaPersidangan Farmakovigilans Asia 2010Pharmacovigilance Asia Conference 2010 26-27 October 2010 Singapore

Persidangan Ubat Tradisional ASEAN Ke-22nd ASEAN Conference on Traditional Medicines

31 October – 2 November 2010 Hanoi, Vietnam

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Kursus Latihan untuk Production of ASEAN Reference Substance: Microbiology AssayTraining Course on the Production of ASEAN Reference Substance: Microbiology Assay

8 & 12 November 2010 Thailand

Program Latihan Berkumpulan - Pengurusan Berkualiti untuk Essential Medicines - APB dan PemeriksaanGroup Training Program - Quality Management Of Essential Medicines - GMP And Inspection

14 November 2010 – 9 December 2010 Tokyo, Japan

Mesyuarat ASEAN Cosmetic Committee (ACC) ke-15 dan Mesyuarat ASEAN Cosmetic Scientific Body (ACSB) ke-1415th ASEAN Cosmetic Committee (ACC) & 14th ASEAN Cosmetic Scientific Body (ACSB) Meetings

16 - 18 November 2010 Hanoi, Vietnam

Mesyuarat ASEAN Consultative Committee for Standards and Quality (ACCSQ) Product Working Group on Traditional Medicines and Health Supplements (TMHS-PWG) Ke-1414th Meeting of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Product Working Group on Traditional Medicines and Health Supplements (TMHS-PWG)

22-25 November 2010 Vientiane Capital, Lao PDR

Cabaran dalam Penilaian Produk Bioterapeutik SerupaChallenges in Evaluating Similar Biotherapeutic Products 27 November 2010 Singapore

Persidangan Antarabangsa Badan Regulatori Ubat Ke-1414th International Conference of Drug Regulatory Authorities

30 November 2010-3 December 2010 Singapore

Seminar Sistem Pendaftaran Ubat 2010 – Asia Tenggara & JepunSouth East Asia & Japan – Medicine Registration System Seminar 2010 9-10 December 2010 Seoul, Korea

Latihan Advanced Therapy Medicinal Products (ATMP)Attachment Training on Advanced Therapy Medicinal Products (ATMPs)

20 September -1 October 2010

Swissmedic, Switzerland

Enhancement of Laboratory Skills in Analysing Chemicals Related to the Chemical Weapons Convention (CW-LSE) 10-21 Mei 2010 Helsinki, Finland

Seminar Latihan PMDAThe PMDA Training Seminar

29 November – 3 December 2010 Tokyo, Japan

121


Penyertaan BPFK dalam Aktiviti Tempatan 2010 / Participation of NPCB in Local Events 2010Persidangan dan Simposium / Conference and Symposium


MesyuaratNational Institues of Health(NIH) Ke-13 & Persidangan Penyelidikan Klinikal Kebangsaan Ke-4 201013th National Institues of Health (NIH) Scientific Meeting & 4th National Conference for Clinical Research 2010

2-4 June 2010

The Royal Chulan, Kuala Lumpur

Persidangan Penyelidikan & Pembangunan Farmasi Kebangsaan Ke-6: Translating Research into Practice and Policy – The Way Forward6th National Pharmacy R&D Conference: “Translating Research into Practice and Policy – The Way Forward”

14-16 June 2010 Penang

Persidangan Bio-Funding 2010Bio-Funding Conference 2010 21 July 2010 Le Meridien, Kuala

LumpurPersidangan Kesihatan Awam (Farmasi) Negeri (Selangor)State Public Health Pharmacy Conference (Selangor)

31 July 2010 - 1 August 2010 Prescott Hotel, Klang

Persidangan Bioavailability/Bioekuivalens (BA/BE) 2010Bioavailability / Bioequivalence (BA/BE) Conference 2010 5 August 2010

Royale Bintang Damansara Hotel,

SelangorPersidangan Saintifik Amalan Farmasi 2010Pharmacy Practice Scientific Conference 2010 15-16 October 2010 Hotel Grand Dorsett,

Subang, SelangorMesyuarat Farmasi OnkologiOncology Pharmacy Meeting 29-31 October 2010 The Westin, Langkawi

Persidangan Pharmaceutical Inspection Co-operation Scheme (PIC/S)Pharmaceutical Inspection Co-operation Scheme (PIC/S) Conference

10-12 November 2010

Le Meridien Hotel, Kuala Lumpur

Kursus/ Courses


ProgramKajian SokonganuntukPenyelidikMudaResearch Support Programme for Young Researchers

20-21 January 2010 UiTM, Shah Alam, Selangor

Kursus Better Spoken English 1/2010Better Spoken English Course Series 1/2010 8-12 February 2010 National Institute of Public

Administration (INTAN)Forum Asma/ Chronic Obstructive Pulmonary Disease (COPD)Asthma/ Chronic Obstructive Pulmonary Disease (COPD) Forum 27 February 2010 JW Marriot Hotel,

PutrajayaKeperluan Kawalan Kualiti untuk Perkilangan BiosimilarQuality Control Requirements for Biosimilar Manufacturing 3-5 May 2010 Le Meridien Kuala Lumpur

Kepimpinan dan Pengurusan Organisasi untuk Pegawai KananLeadership and Management of Organisation for Senior Officers 4-6 May 2010 Concorde Inn, Sepang

Kepimpinan dan Pengurusan Organisasi untuk Pegawai FarmasiLeadership and Organisation Management for Pharmacists

31 October 2010- 3 November 2010

Education Technology Department, Kelantan

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Seminar/ Seminars


Seminar The Insights of Pharmacopeia Tomorrow‘The Insights of Pharmacopeia Tomorrow’ Seminar 10 February 2010 The Saujana Hotel, Shah

AlamSeminar Kesedaran Halal Ke-2 CCM 2010CCM 2nd Halal Awareness Seminar 2010 2 March 2010 Shah Alam Convention

Centre, SelangorSeminar Malaysian Pharmaceutical Society (MPS) (Kemaskini dalam Farmasi Pediatrik)Malaysian Pharmaceutical Society (MPS) Seminar (Updates in Pediatric Pharmacy)

19 – 21 March 2010 Berjaya Times Square Hotel, Kuala Lumpur

Seminar dan Bengkel UsahawanEntrepreneur Seminar and Workshop 31 March 2010 Puspanita, Kuala Lumpur

Seminar Amalan Pengedaran Baik 2010Good Distribution Practice (GDP) Seminar 2010 12-13 April 2010 Technology Park

Malaysia, Bukit JalilForum Pegawai Farmasi untuk Specialty Care UpdatesPharmacists Forum “Specialty Care Updates” 26-27 June 2010 Thistle Hotel, Port Dickson

Seminar MPS-MMA: Doctors & Pharmacists as Partners in HealthcareMPS-MMA Seminar: Doctors & Pharmacists as Partners in Healthcare

11 July 2010 Malaysian Medical Academy, Kuala Lumpur

Seminar Research Updatesdalam Amalan Farmasi, Etika, Undang-undang dan GlobalisasiSeminar on Research Updates in Pharmacy Practice, Ethics, Legislation & Globalization

24 August 2010 Universiti Teknologi MARA(UiTM), Selangor

Seminar National Pharmacy Professional EnrichmentNational Pharmacy Professional Enrichment Seminar 5-7 November 2010 Grand Riverview Hotel

Kelantan.Seminar Antarabangsa Union International Architects (UIA) untuk Kumpulan Kesihatan Awam Ke-3030th International Seminar for Public Health Group (PHG) of the Union International Architects (UIA) 2010

29 November 2010 –

1 December 2010

Kuala Lumpur Convention Centre

Ceramah/ Talks


Safety Labeling Technology: Hologram, DNA Smartmarks, Radio-frequency identification (RFID) & Anti-forgery chops 14 July 2010 Pharmaceutical Services

Division, SelangorCeramah Kerjaya GuardianGuardian Career Talk 30 October 2010 Hilton Hotel, Petaling

Jaya

123


Latihan/ Training


Latihan Site Acceptance Test (SAT) of Freeze DryerTraining on Site Acceptance Test (SAT) of Freeze Dryer 1-5 March 2010 Duopharma (M) Sdn Bhd,

KlangLatihan Amalan Perkilangan Baik (APB) Malaysian of Pharmaceutical Industries (MOPI): International GMP Quality Management Systems and GMP for Pharmaceutical OperationsMalaysian of Pharmaceutical Industries (MOPI) Good Manufacturing Practice (GMP) Training: International GMP Quality Management Systems and GMP for Pharmaceutical Operations

8-10 March 2010 Eastin Hotel, Petaling Jaya

Latihan APB MOPI: Validation Principles and PracticesMOPI GMP Training: Validation Principles and Practices 12-14 April 2010 Eastin Hotel, Petaling

JayaLatihan APB MOPI: Introduction to Computer System Validation: Principle and PracticesMOPI GMP Training: Introduction to Computer System Validation: Principle and Practices

4-6 May 2010 Eastin Hotel, Petaling Jaya

Latihan APB MOPI:Contamination ControlMOPI GMP Training: Contamination Control 17-19 May 2010 Boulevard Hotel, Kuala

LumpurLatihan APB MOPI: Risk Management in Pharmaceutical OperationsMOPI GMP Training: Risk Management in Pharmaceutical Operations

21-23 June 2010 Boulevard Hotel, Kuala Lumpur

Pengenalan Adverse Events Following Immunization(AEFI)Introduction to Adverse Events Following Immunization (AEFI) 25-26 June 2010 Crystal Crown Hotel,

Kuala LumpurKajian Kes cGMP: Kaedah Analitikal, Pemindahan, ValidasicGMP Case Study 3: Analytical Methods, Transfer, Validation 12-13 July 2010 Boulevard Hotel, Kuala

LumpurAmalan Makmal Kawalan Kualiti BaikGood Quality Control Laboratories Practices 19-21 July 2010 Boulevard Hotel, Kuala

LumpurKursus Polisi Ubat Kebangsaan – Zon TimurNational Medicines Policy Course – East Zone 27-29 July 2010 Felda Residence Hotel,

Terengganu

Millipore Best Practices in Filtration for Bio-manufacturing 20 September 2010 Hilton Hotel, Petaling Jaya

Latihan APB MOPI: Compliance with GMP for the Pharmaceutical EngineerMOPI GMP Training: Compliance with GMP for the Pharmaceutical Engineer

21-23 September 2010

Boulevard Hotel, Kuala Lumpur

Latihan APBMOPI: Liquid and Cream Manufacture Principles and PracticesMOPI GMP Training: Liquid and Cream Manufacture Principles and Practices

22-24 November 2010


Amalan APB dan Audit BerkualitiGMP and Quality Auditing Practices

13-15 December 2010


124



Bengkel/ Workshops


Bengkel Komuniti Third Industrial Master Plan (IMP3) (2006-2020)Third Industrial Master Plan (IMP3) (2006-2020) Community Workshop

26 January 2010Ministry of International

Trade and Industry (MITI), Kuala Lumpur

Bengkel Penghantaran Dossier Produk untuk Produk Semulajadi di Amerika SyarikatWorkshop On Product Dossier Submission For Natural Products In The USA

8-12 February 2010 Le Meridien Hotel, Kuala Lumpur

Bengkel Asian Network for Consumer (ANCO)Participation in Standardisation Ke-4 –Meningkatkan KeselamatanProdukmelaluiPenglibatan Pengguna dalamPenyeragaman4th Asian Network for Consumer (ANCO) participation in Standardisation Workshop – Improving Product Safety Through Consumer Participation in Standardisation

1-2 March 2010 Pearl International Hotel, Kuala Lumpur

Bengkel ASEAN untuk MedDRA dan aplikasi dalam Pemantauan Keselamatan UbatASEAN Workshop on MedDRA and its application in Drug Safety Monitoring

17-19 March 2010 Le Meridien, Kuala Lumpur

Bengkel untuk Penyakit Jangkitan/ Osteoporosis/ Penyakit ParkinsonInfectious Disease/ Osteoporosis/ Parkinson’s Disease Workshop

9-11 April 2010Le Meritus Pelangi,

Langkawi

Bengkel Organisasi PelesenanLicensing Organization Workshop 13-16 April 2010 JW Marriot Hotel, Kuala

LumpurBengkel Blueprint Development on 1Care for 1MalaysiaWorkshop for planning the Blueprint Development on 1Care for 1Malaysia

18-21 May 2010 Avillion Admiral Cove, Port Dickson

Bengkel Kesedaran Produk PalsuWorkshop on Awareness of Counterfeit Products 24 June 2010 Sime Darby Convention

CentreBengkel Amalan Regulatori Baik (GRP)Workshop on Understanding Good Regulatory Practice (GRP) 1 July 2010 Department of Standards

Malaysia, CyberjayaBengkel Regulatori untuk Pendekatan Pembangunan Ubat yang InovatifRegulatory Workshop on Innovative Drug Development Approaches

8-9 July 2010

Malaysian Science University (USM), Penang

Bengkel Ophthalmology untuk Pegawai FarmasiThe Pharmacists’ Workshop on Ophthalmology 28 November 2010 The Saujana Hotel, KL

Bengkel untuk Penggunaan Laman Web Modul MS ISO 9001 & Kemaskini DataWorkshop on Usage of Website Module MS ISO 9001 & Data Updating

27 December 2010 Medical Development Division, Putrajaya

125


Persatuan / IndustriAssociation / Industry

Tarikh / Date

Malaysian Homeopathic Medical Council 12 April 2010

Malaysian Direct Distribution Association (MDDA) 19 April 2010

Cosmetic, Toiletry and Fragrance Association (CTFA) 3 May 2010

Malaysian Dietary Supplement Association (MADSA) 17 May 2010

Malaysian Organisation of Pharmaceutical Industries (MOPI) 25 August 2010

Pharmaceutical Association of Malaysia (PhAMA) 13 October 2010

Malaysian Organisation of Pharmaceutical Industries (MOPI) 22 October 2010

Kolaborasi Dengan Industri Tempatan

BPFK kerap menganjurkan mesyuarat dan dialog dengan pihak industri tempatan, persatuan industri, pakar perubatan, gologan akademik, pengguna dan pihak-pihak lain untuk memastikan pelanggan mendapat manfaat yang sepenuhnya dari sistem regulatori BPFK. Sebanyak tujuh sesi dialog telah dianjurkan sepanjang tahun 2010:

Collaboration With Local Industries

The NPCB is actively involved in organising meetings and dialogues with local industry, associations, health professionals, academia, consumers as well as other stakeholders to ensure that all relevant parties could benefit from NPCB’s regulatory system. A total of seven dialogue sessions were conducted in 2010:



PELAWAT ANTARABANGSA & TEMPATAN INTERNATIONAL & LOCAL VISITORS

128



Pelawat Antarabangsa / International VisitorsOrganisasi/Organisation

Bil. Pelawat/No. of Visitors

Negara/Country

Tarikh/Date

Pihak Berkuasa Sains Kesihatan SingapuraHealth Sciences Authority, Singapore 2 Singapore 17 March 2010

Pihak Berkuasa Makanan & Dadah MaldivesMaldives Food & Drug Authority 2 Maldives 26 April - 7 May 2010

Institusi Perdagangan Asing IndiaIndian Institute of Foreign Trade 1 India 15 June 2010

Pusat Teknologi dan Pembangunan Industri FarmaseutikalPharmaceutical Industry Technology and Development Center (PITDC)

7 Taiwan 22 September 2010

Kementerian Kesihatan Hong KongHong Kong Department of Health 5 Hong Kong 9 November 2010

Wakil dari ASEAN-EUProgramme for Regional Integration Support (APRIS)Moderator from ASEAN-EU Programme for Regional Integration Support (APRIS)

1 Ireland 22-25 November 2010

Unit Regulatori Dadah, Kementerian Kesihatan Gaborone, BotswanaDrug Regulatory Unit, Ministry of Health Gaborone, Botswana

2 Botswana 22 November - 3 December 2010

Pihak Berkuasa Makanan & Dadah TanzaniaTanzania Food and Drug Authority 1 Tanzania 6-10 December 2010

Agensi Pengawalan Dadah dan Makanan Kebangsaan (NAFDAC) NigeriaNational Agency for Food and Drug Administration and Control (NAFDAC) Nigeria

1 Nigeria 13-24 December 2010

Pelawat Antarabangsa & TempatanInternational & Local Visitors

129


Pelawat Tempatan/Local VisitorsInstitusi/Institution

Bil. Pelawat/No. of Visitors

Delegasi/Delegates

Tarikh/ Date

Kolej Universiti Taylor’sTaylor’s University College 41 40 Pelajar dan 1 Pensyarah/

40 Students and 1 Lecturer4 January 2010

Hospital Raja Permaisuri Bainun, Ipoh, PerakRaja Permaisuri Bainun Hospital, Ipoh, Perak

40

40 peserta dari Jabatan Farmasi (Kelab Farmasi)/40 visitors from Pharmacy

Department (Pharmacy Club)

19 April 2010

Bahagian Pembangunan Kesihatan Keluarga (BPKK), Jabatan Kesihatan AwamDivision of Family Health Development,Public Health Department

7 Pengarah dan 6 Pegawai/Director and 6 Officers 29 April 2010

PersatuanPerubatanTradisionalIndia, MalaysiaMalaysian Association of Traditional Indian Medicine

1Presiden/President 15 June 2010

Kementerian Kesihatan MalaysiaMinistry of Health, Malaysia 1

Menteri Kesihatan, Dato’ Seri Dr. Liow Tiong Lai

Dato’ Seri Dr. Liow Tiong Lai, Health Minister

5 August 2010

Universiti Perubatan AntarabangsaInternational Medical University (IMU) 14 12 Pelajar dan 2 Pensyarah/

12 Students and 2 Lecturers24 September

2010Kolej Universiti Sains Perubatan CyberjayaCyberjaya University College of Medical Sciences (CUCMS)

31 29 Pelajar dan 2 Pensyarah/Students and 2 Lecturers

12 November 2010


Terima Kasih.Thank you.

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