Expertise of clinical study materials for medicines according to the national procedure

Conducting clinical trials in the territory of the Republic of Kazakhstan are regulated by the Order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 № RK MH-248/2020 "On approval of rules for clinical trials of drugs and medical devices, clinical laboratory tests of medical devices for diagnostics outside a living organism (in vitro) and requirements to clinical sites and providing a public service Issuing approval to conduct clinical studies and (or) trials of pharmacological and medicinal devices" after concluding a contract with the Expert Organization. The Expertise Organization conducts evaluation of the materials on the subject to determine the compliance of the submitted materials with the established requirements in terms of in terms of completeness by volume and correctness of registration, as well as to make a decision on the need (expediency) of clinical research according to the protocol.