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RegisterRussian BE requirement [Regulatives / Guidelines]
Dear All,
nothing like formal accreditation of CROs by Russian Ministry of Health exists. Nevertheless, Russian Ministry of Health carries out CGP and GLP inspections (they are organized by Roszdravnadzor, which is connected with MoH).
Nevertheless for registration of generics, Russia accepts only BE studies conducted in Russia (I mean their clinical part). It is explicitly written in Russian legislation.
Russia has own accreditation system for clinical sites and for investigators (it is not specific for BE or Phase 1, it is a general accreditation to act in clinical studies). The system for accreditation of Clinical Sites was launched approx 2012-13.
nothing like formal accreditation of CROs by Russian Ministry of Health exists. Nevertheless, Russian Ministry of Health carries out CGP and GLP inspections (they are organized by Roszdravnadzor, which is connected with MoH).
Nevertheless for registration of generics, Russia accepts only BE studies conducted in Russia (I mean their clinical part). It is explicitly written in Russian legislation.
Russia has own accreditation system for clinical sites and for investigators (it is not specific for BE or Phase 1, it is a general accreditation to act in clinical studies). The system for accreditation of Clinical Sites was launched approx 2012-13.
Complete thread:
- Russian BE requirement Rasha_J 2016-05-15 10:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Russian BE requirement mittyri 2016-05-18 07:09
- Russian BE requirement Beholder 2016-05-19 15:25
- Russian BE requirement Rasha_J 2017-06-06 11:27
- Russian BE requirementMarika 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
- Russian BE requirementMarika 2017-06-06 19:20
- Russian BE requirement Rasha_J 2017-06-06 11:27
Ing. Helmut Schütz