The Chairman of the Cabinet of Ministers of Kyrgyzstan Adylbek Kasymaliev signed a resolution approving the procedure for conducting clinical trials of medicines in Kyrgyzstan.
According to the document, the testing of medical drugs must be carried out in accordance with established regulations.
The timeframe for reviewing clinical trial materials and issuing a conclusion must not exceed 45 calendar days from the date of confirmation of payment.
The examination of biosimilar, biological and biotechnological drugs is carried out within a period not exceeding 60 calendar days from the date of payment confirmation.
Clinical trials of medicines are conducted in order to confirm the safety and / or effectiveness of drugs.
When conducting an examination of clinical trial materials, the expert council schedules two types of work:
- Examination of the quality and safety of the medical drug;
- Review of clinical trial materials.
The register of clinical trials must be posted in the public domain on the official website of the authorized body in the field of healthcare.
