Russian BE requirement [Regulatives / Guidelines]

posted by Marika – Czech Republic, 2017-06-06 21:20 (2812 d 00:00 ago) – Posting: # 17454
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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.

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