National Pharmaceutical Control BureauMinistry Of Health MalaysiaLot 36, Jalan Universiti46200 Petaling JayaMALAYSIATel : 603-7883 5400 Fax : 603-7958 1312Website : www.bpfk.gov.my

Ministry Of Health

MS ISO 9001:2008 Certified

Member of PharmaceuticalInspection Cooperation

Scheme

WHO CollaboratingCentre

For Regulatory Control ofPharmaceuticals

1

CONTENTS

IntroductionLegislationOverview of Regulatory ControlCategories of ProductApplication FormalitiesHow To Apply and Fees Process of Product Registration Data Requirements Maintenance of Registration

2Overview of Product Registration

Pharmaceutical Services Of MalaysiaDIRECTOR

PharmaceuticalProgramme

DIRECTOR(Pharmaceutical

Care Management)

DIRECTOR(Licensing &Enforcement)

DIRECTOR OF NPCB(Quality Assuranceof Pharmaceuticals)

NATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH MALAYSIA

Objective:To ensure that therapeutic substances approved for the local

market areand of

2

LEGISLATIONS

Other legislations that allow controls and regulations onpharmaceutical sector, include but not limited to thefollowing:

Registration of Pharmacists Act 1951, revised 1989 Poisons Act 1952 (revised 1989) Sale of Drugs Act 1952 (revised 1989) Dangerous Drug Act 1952 (revised 1980) Medicines (Advertisement and Sale) Act 1956 (revised

1983) Patents Act 1983

LEGISLATIONSControl of Drugs and Cosmetics Regulations

(CDCR) 1984

Regulation 7(1)No person shall manufacture, sell, supply, import,

possess or administer any productunless:

(a) the product is a registered product,and

(b) the person holds the appropriate licenserequired & issued under these Regulations.

5Overview of Product Registration

Imported Product

Regulation 12 of CDCR 1984: Licenses a manufacturer's licence, authorising the licensee to manufacture

the registered products in the premises specified in the licence andto sell by wholesale or supply the products;

a wholesaler's licence, authorising the licensee to sell by wholesaleor supply the registered products from the address of the businesspremises specified in the licence;

an import licence, authorising the licensee to import and sell bywholesale or supply the registered products from the address of thepremises specified in the licence. - therefore, imported product suchas from Japan can be imported into Malaysia by an importer whoholds the import license.

Overview of Product Registration 6

Overview of Regulatory ControlRegulatory Components

Registration

Pharmacovigilance

SurveillanceAnalysis

Licensing

7National Pharmaceutical Control Bureau MOH Malaysia

Registration Phases

Overview of Product Registration8

1st January 2008 – Registration of Cosmetics replaced by NOTIFICATION

Surveillance1990

Surveillance1995

Surveillance(to be

announced)

* 1st July 2012:All manufacturers shall be certified for GMP as directed via Directive Arahan di Bawah Peraturan 29,Peraturan-peraturan Kawalan Dadah dan Kosmetik 1984 Bil. 1 Tahun 2012

Phase 1 Phase 2 Phase 3 Phase 4 Phase 5

BIOTECHNOLOGY

VETERINARYMEDICINE

LicensingMay 1987LicensingMay 1987

NEW PRODUCTS

Registration1988(OTC)

Registration1988(OTC)

RegistrationJan 1992

(TraditionalMedicine)

RegistrationJan 1992

(TraditionalMedicine)

RegistrationFeb 2002

(Cosmetics)

RegistrationFeb 2002

(Cosmetics)

RegistrationAug 2007

(Veterinary)

RegistrationAug 2007

(Veterinary)

Licensing1992

Licensing1992

LicensingManufacturer

ImportersJan 1999

LicensingManufacturer

ImportersJan 1999

LicensingJan 2004LicensingJan 2004

Licensing1 July 2012*Licensing

1 July 2012*

LicensingWholesalers

July 2002Surveillance

2000

Surveillance2005

ACTIVEPHARMACEUTICAL

INGREDIENTS

Phase 6

No licensingRequirementsas registration

of API islinked toproducts

No licensingRequirementsas registration

of API islinked toproducts

Regulatorycontrol of

ActivePharmaceutical Ingredient

(API)**

Regulatorycontrol of

ActivePharmaceutical Ingredient

(API)**

Surveillance(to be

announced)

Surveillance(to be

announced)

** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP), followedby mandatory registration of API for NDP which were implemented in January 2012. As for Generics, themandatory registration of API will be announced at a later date.

** Voluntary registration of API commenced in April 2011, started with New Drug Products (NDP), followedby mandatory registration of API for NDP which were implemented in January 2012. As for Generics, themandatory registration of API will be announced at a later date.

Surveillance1995

Surveillance1990

RegistrationAug 1985

(PrescriptionDrugs)

RegistrationAug 1985

(PrescriptionDrugs)

Functions of Center for ProductRegistration

Overview of Product Registration 9

Evaluation of product dossiers. Manual & On-line registration (QUEST 2--> QUEST 3) Product Classification Issuance of Product Registration Certificate Additional Indication of New Chemical Entities (NCEs) &

Biotech Products Certificate of Pharmaceutical Product (CPP) , Certificate

of Free Sale (CFS)

DRGD serves as a referenceguide for both pharmaceuticalproducts for human use andnatural products.(List of Prohibited & RestrictedIngredient – Appendix 8)

A separate guideline is availablefor Cosmetic Notification andregistration of Veterinaryproducts.

10Overview of Product Registration

DRUG REGISTRATION GUIDANCEDOCUMENT (DRGD)

Application Formalities The applicant for product registration (Product

Registration Holder, PRH) must be a locallyincorporated company, corporate or legal entityin the field of pharmaceuticals, with permanentaddress and registered with CompaniesCommissioner of Malaysia with the scope ofbusiness related to the health/ pharmaceuticalproduct.

11Overview of Product Registration

Responsibility ofProduct Registration Holder Responsible for all information pertaining to quality,

safety and efficacy in support of the product registrationapplication; and shall inform the Authority in a timelymanner any change in product information during courseof evaluation. Under the CDCR 1984, Regulation 8(9): Any person who

knowingly supplies any false or misleading informationto the Authority with his application for the registration ofa product commits an offence.

12Overview of Product Registration

Responsibility ofProduct Registration Holder Responsible for all matters pertaining to quality, safety

and efficacy of the registered product, including:- Data updates on product quality, safety and efficacy or

current Good Manufacturing Practice (cGMP) complianceof the manufacturers (and repackers, where applicable).

- Under the CDCR 1984, Regulation 8(5): Any change inany document, item, sample, particulars or informationwhich shall be notified in writing by the applicant to theAuthority within fourteen (14) days from the date of suchchange.

- Any decision to withdraw the registration of the productwith reasons.

Overview of Product Registration 13

Responsibility ofProduct Registration Holder To notify the Authority of any change in correspondence

details, including the name, address, contact person,telephone number, fax number and email;

To notify the Authority immediately upon cessation of theapplicant as the product registration holder;

Overview of Product Registration 14

HOW TO APPLY& FEES

15Overview of Product Registration

Application Procedure

Registration of products shall be done via a web-basedQUEST online system at http://www.bpfk.gov.my

Applicant must first register a membership for QUESTsystem with NPCB and purchase a USB Token thatcontains a User Digital Certificate from Digicert Sdn. Bhd.

NPCB reserves the rights to approve or reject anyapplication for the QUEST membership.

16Overview of Product Registration

17Overview of Product Registration

18Overview of Product Registration

19Overview of Product Registration

Fees(effective as of January 2007)

No ProductCategories

ProcessingFees (RM) Analysis Fees (RM) Total Fees (RM)

1

Pharmaceutical(New DrugProducts &Biologics)

1,000.00

Single active ingredient :3,000.00

4,000.00

Two or more activeingredients : 4,000.00

5,000.00

2

Pharmaceutical(Generics and

HealthSupplements)

1,000.00

Single active ingredient :1,200.00

2,200.00

Two or more activeingredients: 2,000.00

3,000.00

3 NaturalProducts 500.00 700.00 1,200.00

The processing fee is NOT REFUNDABLE [CDCR Reg. 8(4)]20

FEES FOR VETERINARY PRODUCTSProcessing fee + analysis fee: For Scheduled Poison, Non-Scheduled Poison &

Health/ Dietary Supplement products : RM1,500 For Herbal/Natural products : RM1,200 For Export Only-Scheduled Poison : RM 500 For Export Only-Notification for Other than

Scheduled Poison : RM 100

21Overview of Product Registration

Organization of Application Dossier

* Upon Request

Part ITable of

Contents,Common

Administrative Data& Product Information

Part II(Quality)

Overall Summary& Reports

Part IIINon-clinical

(Safety)

Overview,Summary & Study

Reports*

Part IVClinical( Efficacy)Overview,Summary,Assessment Reports,& Study Reports*

Country-specificadministrative data.Not part of ACTD

ACTD

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Overview of Product Registration ProcessPre-Submission of Registration

Application

Submission of RegistrationApplication and Screening

Process

Data Evaluation ** Sample testing** Sample testing

* GMP Inspection* GMP Inspection

Meeting of the Drug Evaluation Committee (twicemonthly)

Meeting of the Drug Control Authority(monthly)

*** Licensing*** Licensing

ApprovalApproval

Post-RegistrationPost-Registration

RejectionRejection AppealAppeal

* Good Manufacturing Practice (GMP) Certification** For natural products only*** Application for Import and/or Wholesale License

Regulation 18, CDCR 1984

Assigning a registration number(MAL no.) & Issuance of

certificate

Surveillance &Pharmacovigilance,

Amendments/Variation

Products Particulars ProductFormulation

LabelingRequirement

Interchangeability

Manufacturer- GMP- CPP- CFS

Registration Criteria(Quality, Safety, Efficacy)

CompulsorylabelingrequirementAdditionalWarning/Precaution

Product NameProductDescriptionPack sizeType of container

Bioequivalence/Bioavailability

Studies

BannedingredientLimitsProduct testingFPQC, Stability

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REGISTRATION PROCESS

Evaluation of application dossier

Product EvaluationCommittee (within NPCB)

Drug Control Authority(decision making body

– meets monthly)

Application rejected

Registered

Applicant can appeal through Minister ofHealth for review of DCA’s decision

Verification of GMP status (approval from recognizedauthority of the country of origin), CPP and CFSProtocol Evaluation and TestingNCE/Biotechnology – send to panel of experts for comments

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Timeline

26Overview of Product Registration

No. Product Category * Duration(Inclusive screening

process)(A) Full Evaluation

1. New Drug Products 245 working days

2. Biologics 245 working days

3. Generics (Scheduled Poison) 210 working days

4. Generics (Non-Scheduled Poison) 210 working days

* Upon receipt of complete application.

Timeline

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No. Product Category *Duration(Inclusive screening

process)(B) Abridged Evaluation

5.Generics (Non-Scheduled Poison)(Product categories as stated in Table V above)

80 working days

6.Natural Productsa) Single active ingredientb) Two (2) or more active ingredients

a) 116 working daysb) 136 working days

7.Health Supplementsa) ** Single active ingredientb) ** Two (2) or more active ingredients** Applicable for:i) General or Nutritional Claims; andii) Functional Claims (Medium Claims)

c) Disease Risk Reduction Claims(High Claims)

a) 116 working daysb) 136 working days

c) 245 working days

* Upon receipt of complete application.

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http://www. bpfk.gov.my

Biologics include a wide range of products such as: Vaccines; Blood products; Monoclonal antibodies (therapeutics); Recombinant proteins: Hormones Erythropoetins and other hematopoietic factors Cytokines: Interferons, interleukins, colony-

stimulating factors, tumour necrosis factors. Cell and tissue-based therapy products Gene therapy products

29Overview of Product Registration