The Republican State Enterprise operating on the basis of the right of economic management, known as the “National Center for Expertise of Medicines and Medical Devices,” operates under the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan (hereinafter the Enterprise). The Enterprise serves as a state expert organization overseeing the commercial distribution of medicines and medical devices. It is entrusted with functions related to the state monopoly, including:
1) Expert examination of medicines and medical devices in the course of state registration, re-registration, and amendment of registration dossiers.
2) Conducting assessments of the quality of medicines and medical devices registered in the Republic of Kazakhstan.
3) Evaluating the benefit-risk ratio of medicines and medical devices.
4) Assessing optimal technical characteristics and clinical-technical justification of medical devices.
5) Evaluating materials for conducting clinical trials of medicines and medical devices.
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