The requirement to conduct the third phase of clinical trials (CT) of a drug in Russia, if it is already registered abroad, can be cancelled. This was stated at a round table in the Federation Council by the chief freelance oncologist of the Ministry of Health of Russia, the general director of the National Medical Research Center for Radiology, Academician of the Russian Academy of Sciences Andrey Kaprin, the Senate Inform portal reports.
According to the scientist, the third phase of research is “commercial”. At the same time, it takes three to four years to conduct it, during which the drug could be used and help patients.
In March, the All-Russian Union of Patients asked the government to impose a moratorium on the requirement to conduct clinical trials of foreign drugs with the participation of Russian patients, which limits access to modern methods of therapy. For their registration, it is proposed to allow the submission of data from international multicenter clinical trials performed in accordance with the standards of good clinical practice as part of the registration dossier. However, the Ministry of Health stated that it considers this inappropriate.
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