Regulatory Focus™ > News Articles > Russia: New Clinical Trial Regulations In Effect

Russia: New Clinical Trial Regulations In Effect

Posted 11 April 2012 | By Louise Zornoza

New regulations governing the conduct of preclinical studies and clinical trials of drugs for medical use have entered into force in Russia, which require the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) to implement control measures and the analysis of study and trial results. 

The regulations also establish appeal procedures for Roszdravnadzor decisions. The changes stem from an order of the  Ministry of Health issued on September 29, 2011, implementing legislation enacted  on  12 April 2010.


Read more:

Russia - Administrative Rules: Roszdravnadzor to monitor the conduct of preclinical studies of drugs and clinical trials of drugs for medical use

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