Russia: New Clinical Trial Regulations In Effect
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.
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