;   Medical Translation Insight: Russia modifies clinical trial regulations; works hard to grow pharma sector - ForeignExchange Translations

Russia modifies clinical trial regulations; medical translation
Emerging countries such as India, Russia, and China boast clinical sites that serve large numbers of patients and are staffed with qualified, motivated physicians, and are hence well suited to be high-performing clinical trial sites. However, many fail to consistently deliver their potential both in terms of data quality and subject recruitment.

18 months after Vladimir Putin promised to transform Russia into a biotech heavyweight by 2020, the country may be witnessing a growing volume of clinical trial activity but Russian pharma is incapable of going through the entire process from discovery to clinical trials and manufacturing. According to one estimate, only 10 percent of Russian factories meet Good Manufacturing Practices - and these are factories that generally produce the most basic of products: very old medicines, bandages, and vitamins.

But changes are underway. One need to look no further than the new regulations governing the conduct of pre-clinical 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 were reported earlier this year and also establish appeal procedures for Roszdravnadzor decisions. The changes stem from an order of the Ministry of Health issued on September 29, 2011.

The regulations are available (in Russian) on Roszdravnadzor's web site.

[Hat tip to Regulatory Focus]

For more Russian drug and device information, take a look at the following:
ForeignExchange Translations provides specialized medical translation services for clinical research groups at pharmaceutical and medical device companies - in Russian and in dozens of other languages.
 
 

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