Expertise of medicinal products in the Republic of Kazakhstan
Expertise of medicinal products is study or testing of drugs for their safety, efficacy and quality through physical & chemical, biological, preclinical (non-clinical) studies, clinical studies, determining bioequivalence, as well as examining the registration dossier documents, regulatory documents on standardization submitted to registration as prescribed by the authorized body.
Expertise of medicinal products in the Republic of Kazakhstan pertains to the government monopoly, is carried out by the National Center, which is the government expert organization in the field of circulation of medicinal products, medical devices and medical equipment.
The procedure for the expertise of medicinal products and dates are determined by order of the Minister of Health of the Republic of Kazakhstan dated from 18 November 2009 No. 736 “On approval of the Rules for the expertise of medicinal products, medical devices and medical equipment” , which was amended on 15 June 2018.
For the expertise of the medicinal products, manufacturers of the Republic of Kazakhstan shall submit the list of documents as specified in Annex 2 of the Order.
The papers of the registration dossier for a medicinal product to be provided for expertise by foreign manufacturers comply with Annex 1 of the Rules for Registration and Expertise of Medicinal Product for Human Use, approved by the Decision of the Council of the Eurasian Economic Commission dated from 3 November 2016 No. 78.
The expertise of the medicinal product consists of the following milestones:
1) primary expertise (validation of the registration dossier);
2) specialized expertise;
3) laboratory tests.
During the primary expertise (validation of the registration dossier) of a medicinal product, the totality, completeness and correctness of paperwork submitted by the applicant in the registration dossier regarding the evidence of safety, efficacy and quality of the medicinal product are assessed.
An affirmative result of the primary expertise (validation of the registration dossier) of a medicinal product is the basis for conducting a specialized expertise of the medicinal product as per dates stipulated by Chapter 6 of these Rules.
Specialized expertise of the medicinal product includes the study of the registration dossier documents regarding the safety, efficacy and quality of the medicinal product by evaluating papers of preclinical (non-clinical), clinical studies, bioequivalence tests, analysing data on the quality of the medicinal product, including the assessment of pharmacokinetic and/or pharmacodynamic interactions for compliance with the List of irrational drug combinations.
Following the results of the specialized expertise, a Summary Report of Experts on the Evaluation of a Medicinal Product as specified in Annex 7 to these Rules and a Summary Report of Experts on the Evaluation of a Medicinal Product in case of changes to the Registration Dossier as stipulated by Annex 8 to these Rules are compiled. The expert report on the evaluation of the medicinal product reflects all aspects of the safety, efficacy and quality of the medicinal product.
Laboratory tests of the medicinal product are carried out in testing laboratories of the government expert organization in order to confirm the compliance of safety and quality indicators of the medicinal product and include:
1) testing of the samples of medicinal product;
2) determination of the reproducibility of analysis techniques.
Test of the medicinal products samples using a set of physical & chemical, biological studies is aimed at determining the quantitative and qualitative content of active substances and excipients, impurities, and biological safety (microbiological purity, toxicity, pyrogenicity).
The determination of the reproducibility of the analysis techniques to control the quality of a medicinal product shall be carried out in order to confirm their compliance, as provided for in the quality regulatory document.
Each of the above expertise milestones shall meet the terms provided for by Chapter 6 of the Order and be implemented by a group of experts of the government expert organization involving (if required) freelance profile experts.
Resulting from the expertise of the medicinal product, an opinion on the safety, efficacy and quality of the medicinal product that is declared for expertise as stipulated by Annex 11 of the Order and an opinion on the safety, efficacy and quality of the medicinal product declared for expertise of changes made to the registration dossier according to Annex 12 of the Order, are drawn up.
The government expert organization shall provide the government body with documents in electronic form with an electronic digital signature of the head (or authorized person) and persons-in-charge who conducted the expertise as follows:
· opinion on the safety, efficacy and quality of the medicinal product;
· quality regulatory document, approved by the applicant and agreed by the expert organization;
- patient information leaflet in the Kazakh and Russian languages being designed in accordance with the Rules for the preparation and execution of the patient information leaflet and agreed by the expert organization;
- package design, labels layout, drug stickers layout, in Kazakh and Russian languages, agreed by the expert organization.
The opinion on the safety, efficacy and quality of the medicinal products is valid within one hundred and eighty calendar days. Should the opinion expire, the applicant resubmits the application, documents and materials for the expertise of the medicinal product in the prescribed manner.