Department of Pharmacovigilance and Monitoring of Safety, Effectiveness and Quality of Medical Devices
The main purpose of the Department of Pharmacovigilance and Monitoring of Safety, Effectiveness and Quality of Medical Devices (hereinafter – DPMSE& QMD) is to ensure qualitative scientific and specialized expertise in the evaluation of "benefit-risk" relationships of registered medicines and medical devices that are in circulation in the Republic of Kazakhstan, in accordance with the laws of the Republic of Kazakhstan and the internal regulations of the Company taking into account international recommendations, standards and international best practices.
Based on the goal set, DPMSE&QMD carries out its activities in the main directions in the post-registration period:
1) pharmacovigilance of medicines;
2) monitoring the safety of medical devices (MD);
3) evaluation of benefits-risk ratio of medicines and medical devices
4) expert review of materials during medicine re-registration.
The main areas of work of the pharmacovigilance (PH) system in the Republic of Kazakhstan are:
1) carrying out the collection, analysis and synthesis of information on the safety and efficacy of medicines and medical devices received from healthcare subjects, registration holders, international organizations;
2) evaluation of benefit-risk ratio of registered and circulating medicines and medical devices in the territory of the Republic of Kazakhstan;
3) ensuring control of PH functioning in health care system and registration certificate holder (RCH);
4) review of documents and materials submitted by the holder of registration certificate, as well as the results of signal assessment, leading to a change in the ratio "benefit-risk" of medicines and medical devices, at the meeting of the Commission on the evaluation of the ratio "benefit-risk" in the post-registration period;
5) preparation of proposals for the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan on complete or partial prohibition of medical use of medicines and medical devices, making additions or changes in general characteristics of medicine instructions for medical use (leaflet insert);
6) specialized expert review during medicine re-registration;
7) information and methodological support of the health care system on medicine and medical devices safety issues.