Russia BE Study [Regulatives / Guidelines]

posted by Beholder  – Russia, 2020-10-02 09:24 (60 d 23:12 ago) – Posting: # 21963
Views: 1,626

Dear Brus and Helmut,

I know for sure that it is possible to conduct bioanalytics and PK assessment outside of Russia. I saw many times such situation within my 8-years experience.

Regarding the source. There is no exact wording in the laws that it is possible to conduct bioanalytics and PK assessment outside of Russia. But from experience it is so. You may also look at this doc from 2012 (it presents the EPRD analysis of clinical trials system in Russia and compares it to EU system in some cases). Not lots of things have been changed since 2012;-). Just search for word "local" and you will see that there was no any exact reference to law found even by EPRD. The necessity to conduct clinical trials is written indirectly in FZ 61:
"5. In the Russian Federation, in accordance with international treaties of the Russian Federation and / or on the basis of the principle of reciprocity, the results of clinical trials of medicinal products for medical use conducted outside the territory of the Russian Federation are recognized.". But Russia has no any international treaties and no one recognize the clinical trials conducted in Russia. So it means that you need local clinical trial conducted in Russia.

Best regards
Beholder

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