Expertise of medicines

Expertise of drugs and medical devices is a comprehensive assessment of safety, quality and effectiveness, the "benefit-risk" ratio, assessment of materials for clinical research of drugs and medical devices, evaluation of optimal technical characteristics and clinical and technical substantiation of a medical device, carried out on the basis of registration dossier materials, laboratory tests for compliance with the regulated quality, pharmacovigilance data, safety, quality and effectiveness monitoring of medical devices materials for clinical research evaluation, materials for evaluation of optimal technical characteristics and clinical and technical substantiation of a medical device.

State expert organization in the field of circulation of medicines and medical devices - the subject of the state monopoly, carrying out production and economic activities in the field of health care to ensure the safety, efficacy and quality of medicines and medical devices.

The order conducting of expertise of medicines and terms are determined by the Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021, No. RK MH-10 "On approval of the rules of examination of medicines and medical devices" (hereinafter – the Order).

Specialized expertise of a medicinal product includes assessment of safety, quality and efficacy and benefit-risk ratio of the medicinal product based on the analysis and expertise of data in the registration dossier documents, including the results of laboratory trials of the medicinal product samples, analysis of the pharmaceutical inspection report at the state registration of medicinal products, as well as the evaluation of the rationality of the active substance combination in the composition of the medicinal product in accordance with the List of Irrational Medicinal Product Combinations according to Appendix 9 Order.

For the examination of a medicinal product, manufacturers of the Republic of Kazakhstan provide a list of documents in the form according to Appendix 2 Order.

Materials of the registration dossier of a medicinal product submitted for expertise by foreign manufacturers comply with Appendix 3 Order.

Specialized expertise conducts within the time limits stipulated in Chapter 6 Order.

Based on the results of the study of the registration dossier documents at the stage of specialized expertise, a summary request (in any form) on safety, quality and efficacy of the medicinal product sends to the applicant.

The applicant within sixty calendar days shall send a full response and necessary materials to the request of the state expert organization.

If additional questions arise concerning the information provided by the applicant in the response to the previous request, the applicant, within thirty calendar days of receipt of the request, shall send a response and necessary materials to the additional request to the state expert organization.

Based on the results of the expert review, the state expert organization generates a summary report on safety, quality and efficacy of the medicinal product, part of which posted on the website of the National Center.

Based on the results of the expert examination of the medicinal product, the state expert organization draws a conclusion about safety, quality and efficacy of the medicinal product applied for expert examination according to Appendix 14 Order and a conclusion about safety, quality and efficacy of the medicinal product applied for examination of changes in the registration dossier according to Appendix 15 Order.

The state expert organization sends electronically with the electronic digital signature of the head (or authorized person) and responsible persons who carried out the expertise to the state body:

• a conclusion on the safety, quality and efficacy of the medicinal product;
• general description of the drug, instruction for medical use of the drug (leaflet insert) in Kazakh and Russian, developed in accordance with the procedure stipulated by clause 4 of Article 242 of the Code and agreed upon by the expert organization;
• layouts of packages, labels, stickers of the drug, in the Kazakh and Russian languages, agreed by the expert organization.

Conclusion on safety, quality and efficacy of a medicinal product is valid for one hundred and eighty calendar days. In case of expiry of the conclusion, the applicant shall re-submit an application, documents and materials for expert examination of the medicinal product in accordance with the established procedure.