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PHARMACOVIGILANCE SYSTEM IN KAZAKHSTAN

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

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PHARMACOVIGILANCE SYSTEM IN KAZAKHSTAN

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  1. MINPROMTORG OF RUSSIA SID & GP IV ALL-RUSSIA GMP CONFERENCE Corporate Communication Center 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 PharmacovigilancePractice - GVP) • The order of the Ministry of Health and Social Development of the Republic of Kazakhstan dated May 29, 2015 No. 421Rules 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. 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 MoHof the RoK National Center for Expertise of DPand MD for CQCESGS of the MoH of the RoK Territorial and Representative offices Territorial Departments of CQCESGS 17

  4. Interaction system NATIONAL CENTER FOR EXPERTISE of drug products, medical devices and medical equipment • 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. • Causalitystatement 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 Holderinspection • Suspension / Revocation of MA for DP and MD

  5. Pharmacovigilance Pharmacovigilance System: 3 6 4 2 5 1 Monitoring of DP safety data from other sources Collection and verification of reports on DP AR Annual assessment of DP benefit-risk balance Regulatory actions Analysis, assessment and examination of DP safety data from MAH Evaluation of signals based on the database for monitoring of DP SE

  6. Current state

  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

  8. Thank you for your attention • Questions? • Contact details: • Website: ndda.kz • E-mail: m.abdrakhmanov@dari.kz • Phone: +77172 78 98 28

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