1. PHARMACOVIGILANCE SYSTEM
SID & GP
MINPROMTORG OF RUSSIA
Corporate
Communication
Center
IV ALL-RUSSIA GMP CONFERENCE
PHARMACOVIGILANCE SYSTEM
IN KAZAKHSTAN

2. Regulatory documents
Code of the Republic of Kazakhstan dated September 18, 2009 “On Public Health and Health Care System” - Article 85 “Pharmacovigilance and monitoring of the safety, quality and effectiveness of medical devices”
Order of the Ministry of Health and Social Development of the Republic of Kazakhstan No. 392 dated May 27, 2015 “On Approval of Good Pharmaceutical Practices” Appendix 6 (Good Pharmacovigilance Practice - GVP)
The order of the Ministry of Health and Social Development of the Republic of Kazakhstan dated May 29, 2015 No Rules for conducting Pharmacovigilance of medicines and monitoring side effects of medicines, medical devices and medical equipment.
The order of the Ministry of Health and Social Development of the Republic of Kazakhstan dated February 27, 2015 No. 106 “On Approval of the Rules for the Prohibition, Suspension or Withdrawal of Medicines, Medical Devices and Medical Equipment”
Order of the Minister of Health of the Republic of Kazakhstan dated November 12, 2009 No. 701 “On Approval of the Rules for the Withdrawal of Samples of Medicines, Medical devices and Medical Equipment for Expert Evaluation”
Decision dated November 03, 2016 No. 87 “On Approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”

3. of the Republic of Kazakhstan
Regulation of the circulation of DP and MD in the Republic of Kazakhstan
Ministry of Health
of the Republic of Kazakhstan
Committee for Quality Control, Efficiency and Safety of Goods and Services of the MoH of the RoK
National Center for Expertise of DP and MD for CQCESGS of the MoH of the RoK
Territorial Departments of CQCESGS 17
Territorial and
Representative offices

4. Information on side effects of DP
Interaction system
NATIONAL CENTER FOR EXPERTISE
of drug products, medical devices and medical equipment
CQCESGS Committee
of the MoH of the RoK
Information on side effects of DP
Inform about serious adverse reactions (death, life threatening, lack of effectiveness, abuse, off-label use, unregistered drugs) within 48 hours.
Causality statement and benefit-risk balance.
Regulatory actions
Sample collection
Prohibition of medical use and withdrawal from circulation or suspension of medical use of a batch (lot) of DP
Amendment of instructions for medical use
Appointment of a Marketing Authorization Holder inspection
Suspension / Revocation of MA for DP and MD

5. Pharmacovigilance System:1 2 3 4 5 6
Collection and verification of reports on DP AR
Monitoring of DP safety data from other sources
Analysis, assessment and examination of DP safety data from MAH
Annual assessment of DP benefit-risk balance
Evaluation of signals based on the database for monitoring of DP SE
Regulatory actions
10. An authorized organization monitors the safety of medicines, medical devices and medical equipment in circulation on the market of the Republic of Kazakhstan in order to continuously assess the benefit-risk balance throughout the entire period of circulation of medicines, medical devices and medical equipment in order to ensure public health protection and enhance patient safety.

6. Current state Training of specialists at the level of universities
Creation of an experience exchange program as a part of strategic cooperation
Lack of trained staff
Active work with health professionals
Integration with electronic medical history and health passport
Decreased report activity
Software development
Simplification of expert work
Software imperfection

7. Prospects Reorganization Creation of new units
Involvement of freelance specialists, industry experts
Implementation
New technological solutions
Pharmacoepidemiology
Development
Risk-based approach
Integration into the system of PV EAC
Preparation of undergraduate programs, PHD in PV

9. Thank you for your attention
Questions?
Contact details:
Website: ndda.kz
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