“Pharmacovigilance in the Republic of Kazakhstan -Peculiarities. Biological medicinal products safety monitoring” Shows the current pharmacovigilance system and practices in Kazakhstan, with a focus on biotherapeutic medicines

1. Pharmacovigilance in the Republic of Kazakhstan
Peculiarities Biological medicinal products safety monitoring
The National Center for Drug Expertise, Medical items and Equipment
Ministry of Public Health
Republic of Kazakhstan
Sh. Baidullayeva
Head of Department for Pharmacological Assessment
15-16 мая 2013, Москва
Биотерапевтические препараты. Современные вызовы и регуляторные практики. Подходы к
гармонизации.

2. 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”

3. 3
MPhACC*
Department forPharmacological
assessment
ADRs monitoring group
Ministry of Healthcare
National Centre forDrug expertise
The structure of Pharmacovigilance in Kazakhstan
*MPhACC - the Medical and Pharmaceutical activity
control Committee

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

5. 5
Medical workersMedical workers
PharmaceuticalPharmaceutical
workersworkers
CustomersCustomers
Territorial branches ofTerritorial branches of
MPhACC and NCDEand NCDE,,
Departments of PublicDepartments of Public
Health servicesHealth services
MPhACCMPhACC
NCDENCDE
Granting the
information
Information
collection
Information analysis
and decision-making
Information
accumulation
Information
Distribution
Informationaboutadverseeffects
Informing system of drug adverse reactions
WEB -SITEWEB -SITE
CDCD
Data baseData base
PrintingPrinting
publicationspublications
PharmaceuticalPharmaceutical
manufacturersmanufacturers
NCDENCDE
ADRs monitoring groupADRs monitoring group
Uppsala WHOUppsala WHO
VigiFlowVigiFlow

6. • “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
6

7. 7

8. • 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

9. • The MAHneeds to report CIOMS I
concerning serious ADRs that have
been detected outside Kazakhstan
and which have not been listed in
SmPC oranothercompany Core Data
Safety
CIOMS I
Order of the ADRS monitoring rules

10. 10
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

11. 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

12. 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

13. ADRs monitoring over 2005 to 2012: total 3938 reports

14. 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

15. Biological medicinal product ADRs monitoring (by ATC Code)

16. Biological medicinal product ADRs monitoring
(by WHO-ART)

17. 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

18. 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

19. http://www.dari.kz

20. Thank you for attention!