The Ministry of Health may cancel compulsory trials for imported medications

The Federal Antimonopoly Service's (FAS) proposal to cancel clinical tests for US and EU approved medications is currently being considered. This was reported by the Ministry of Health when commenting on the relevant letter from Igor Artemiyev, the Head of the FAS.

The Ministry of Health may cancel compulsory trials for imported medications

The Federal Antimonopoly Service's (FAS) proposal to cancel clinical tests for US and EU approved medications is currently being considered. This was reported by the Ministry of Health when commenting on the relevant letter from Igor Artemiyev, the Head of the FAS.

The letter mentioned lengthy bureaucratic registration procedures faced by new medicines successfully applied in West. The need to redo local (Russian) clinical tests represent the main barrier. This results in pharmaceutical companies that have spent huge amounts to prove the effectiveness and safety of their new developments to register their products in foreign countries being forced to incur additional costs to arrange supplies to Russia. According to the FAS, it is sufficient in developed countries to submit the results of tests done in accordance with international good clinical practice standards (GCP) while the place of the tests makes no difference. The Head of the FAS believes it is necessary to accept clinical tests registered with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) because their reputation allows to acknowledge the quality and safety of medicines.

The FAS's initiatives are now being considered in the Ministry of Health jointly with concerned federal executive authorities. At the same time, the governmental agency's representatives have noted that an effective provision of the Federal Law "On the Circulation of Drugs" already allows to recognize the results of clinical tests made in a foreign jurisdiction, on a reciprocal basis however.