Bioequivalence and Bioavailability Forum • Russian BE requirement

Russian BE requirement [Regulatives / Guidelines]

posted by Beholder – Russia, 2016-05-19 17:25 (2891 d 14:34 ago) – Posting: # 16333
Views: 7,782
(edited by Beholder on 2016-05-20 10:20)

❝ Can you please advise if you have to be an approved CRO by Russian MOH before you run and submit a study to Russia...

Hello Rasha_J!

I have never heard about such approval from Ministry of Health for CRO. I know that there is such approval (accreditation) for medical sites (clinics). There is a list of all clinics approved and one can see this list on special site. Also there is special procedure and application for that. So if such procedure was for the CRO then it would need a special list of CRO. But I never saw such a list before.

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Best regards
Beholder

Complete thread:

Russian BE requirement Rasha_J 2016-05-15 10:39 [Regulatives / Guidelines]
- Russian BE requirement mittyri 2016-05-18 07:09
- Russian BE requirementBeholder 2016-05-19 15:25
  - Russian BE requirement Rasha_J 2017-06-06 11:27
    - Russian BE requirement Marika 2017-06-06 19:20
      - List of accredited clinical sites Helmut 2017-06-06 23:55
      - Russian BE requirement Beholder 2017-06-07 16:23
      - Russian BE requirement Beholder 2017-06-23 10:13