Pharmacovigilance in the Republic of KazakhstanPeculiarities Biological medicinal products safety monitoring

The National Center for Drug Expertise, Medical items and EquipmentMinistry of Public HealthRepublic of Kazakhstan

Sh. BaidullayevaHead of Department for Pharmacological Assessment

15-16 мая 2013, МоскваБиотерапевтические препараты. Современные вызовы и регуляторные практики. Подходы к

гармонизации.

Kazakhstan Pharmacovigilance legislation

the Kazakhstan Health Code (18.09.2009)

the MoH Orders under №735 (18.11.2009)

the MoH Orders under №647 (03.11.2009) “Relating to the ADRs monitoring”

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MPhACC*

Department for Pharmacological

assessment

ADRs monitoring group

Ministry of Healthcare

National Centre for Drug expertise

The structure of Pharmacovigilance in Kazakhstan

*MPhACC - the Medical and Pharmaceutical activity control Committee

MPhACC’s** as a regulatory body Kazakhstan Ministry of Public health

The National Center for Drug Expertise, Medical items and Equipment’s on expert body in medicinal products regulation

Local ADRs reports, CIOMS reports, PSURs, pharmacovigilance data from other countries

Ministry of Public Health

Pharmacovigilance data assessment to make recommendations for taking regulatory measures

Regulatory measures to Suspend MA, Withdraw MA or Variations

for MA based on recommendation NCDE*

*NCDE - The National center for drug expertise, medical items and equipment

**MPhACC - the Medical and Pharmaceutical activity control Committee

The structure of Pharmacovigilance in Kazakhstan

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Medical workersMedical workers

Pharmaceutical Pharmaceutical workersworkers

CustomersCustomers

Territorial branches of Territorial branches of MPhACC and NCDE and NCDE, ,

Departments of Public Departments of Public Health servicesHealth services

MPhACCMPhACC

NCDENCDE

Granting the information

Informationcollection

Information analysis and

decision-making

Information accumulation

InformationDistribution

Info

rmat

ion

abou

t adv

erse

eff

ects

Informing system of drug adverse reactions

WEB -SITEWEB -SITE

CDCD

Data baseData base

Printing Printing publicationspublications

Pharmaceutical Pharmaceutical manufacturersmanufacturers

NCDENCDE

ADRs monitoring groupADRs monitoring group

Uppsala WHO Uppsala WHO VigiFlowVigiFlow

• “Yellow card-message” is the main instrument to monitor ADRs

• In case of any ADRs or the lack of effect the medical professionals, pharmaceutical companies, patients and pharmacists will fill in this card-message

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• It is required to report to the NCDE on emergency basis on all suspected serious anticipated and unexpected ADRs within 24 hours

• The reporting term for non-serious ADRs is 15 calendar days, or they can be included into next PSUR.

Reporting terms

Order of the ADRs monitoring rules

• The MAH needs to report CIOMS I concerning serious ADRs that have been detected outside Kazakhstan and which have not been listed in SmPC or another company Core Data Safety

CIOMS I

Order of the ADRS monitoring rules

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Terms for PSUR submitting

• For new registered products PSUR will be submitted every 6 months over the first 2 years and once a year over 3 years

• For reregistered products PSUR will be submitted over re-registration process ever 5 years

Order of the ADRS monitoring rules

PSURs form in Kazakhstan

• has been approved for execution on the territory of Kazakhstan by the State Pharmaceutical Control Committee Order №170/2008

Order of the ADRS monitoring rules

RISK MANAGEMENT PLAN

1) Applying for marketing authorization:

New active substance medicinal product; Biosimilar, and also biological product manufacturing variation; Original medicinal product’s new form, administration, indication

extending, including variations for indication in pediatry and major changes for indications ;

Generic product with additional risk minimization measures in case information about risks related to original product;

2) At MPhACC or NSDE’s requests during or after registration procedure

ADRs monitoring over 2005 to 2012: total 3938 reports

Name Year Decision

Polyvinylpyrrolidone with a molecular weight of 12600 2007 Banned

Gatifloxacin 2009 Banned

Boric acid and its derivatives (eye / ear drops, solution for external use)

2009 Restricted: not more than 3%

Nimesulid 2009 Contraindicated in patients younger than 18 years

Could and cough fixed combination formulations containing paracetamol with pseudoephedrine, caffeine, dextromethorphan

С 2010 Contraindicated for children up to 12

Could and cough fixed combination formulations containing paracetamol with ephedrine, codeine

С 2010 Contraindicated for children up to 14

Paracetamol more than 500 mg in single dosage С 2010 No longer registration/re-registration

Combinations of two or more NSAID С 2010 No longer registration/re-registration

Pancreatin combination with other enzymes, bovine bile

С 2010 No longer registration/re-registration

Metamizol combinations С 2010 No longer registration/re-registration

Pioglitazone 2011 Suspended

Sibutramin 2011 Banned

Rasilez 2012 Suspended

Tredaptive 2013 Under withdrawing

Calcitonin 2013 Under withdrawing

Kazakhstan regulatory measures

Biological medicinal product ADRs monitoring (by ATC Code)

Biological medicinal product ADRs monitoring (by WHO-ART)

Risk management plan • Implementation started from 2012 for the following products

Name Company

Lusentis (ranibizumab) Novartis Pharma

Enpleyt (romiplostim) Pateon SpA Italy

Sebivo (Telbivudine) Novartis Pharma

Tasigna (Nilotinib) Novartis Pharma

Stelara ® (ustekinumab) Cilag AG

ADRs monitoring improvement measures

• 1. Joined plan with the Public health service departments and MPhACC’s branch-departments in 14 regions

• 2. Working group on proposal development in Pharmacovigilance legislation: NCDE, pharmaceutical companies

• 3. Collaboration with the Drug information center, Scientific-research Institutes

• 4. Postmarketing studies: non-interventions, safety studies

• 5. Implementation of Risk management plan

http://www.dari.kz

Thank you for attention!