The Ministry of Health opposed the abolition of mandatory national clinical trials

The Ministry of Health insists on the mandatory conduct of clinical trials of drugs in Russia for their registration, Deputy Minister Sergei Glagolev said at the Biotechmed forum. If the department is limited to taking into account the results of foreign tests, this will deprive the possibility of integrating Russian experience into world science.

The issue of preserving national research remains the key position of the regulator, Sergei Glagolev said. “These are not bureaucratic obstacles, this is the acquaintance of our doctors with the drug in the early stages and the integration of our clinical bases into world science,” he explained. The introduction of concessions should be on both sides, Mr. Glagolev believes.

Now only when registering orphan drugs in Russia it is allowed to use the results of clinical trials conducted in other countries. An accelerated registration procedure – before the completion of all phases of studies – is possible, for example, for drugs against COVID-19. Meanwhile, most of the largest foreign pharmaceutical manufacturers refused to conduct new clinical trials in Russia after the start of a special operation in Ukraine.

Center for Mathematical Modeling in Drug Development of the First Moscow State Medical University. I. M. Sechenova calculated that because of this, in the next ten years, Russian patients may not receive 300 drugs that are currently under development.

Polina Gritsenko