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Emerging Market for Clinical Trials in Russia
Emerging Market for Clinical Trials in Russia
Contract Research Organization (CRO) Market in Russia is set to Grow due to Implementation of New Drug law
London,
London,
United Kingdom
(prbd.net)
09/06/2011
The CRO market in Russia is set to increase due to the implementation of a new federal law “On
circulation of medicines” (September 2010). According to this law, the registration of a new drug
can only be achieved in the country if the international multicenter clinical trial for the drug is also
conducted in Russian sites. In addition, the registration of any generic drug in Russia can only be
done if the bioequivalence study is also performed in Russia.
The value of the CRO market in Russia is forecast to reach $309m by 2017, growing at a
Compounded Annual Growth Rate (CAGR) of 9.5% from 2009 to 2017. The increase in the market
from 2009 to 2010 was comparatively small because stagnation in the market was observed due to
adaptation of the new law. This involved the transfer of responsibility of issuing licenses for
conducting clinical trials from “Federal Services on Monitoring Health Care and Social
Development" to the "Ministry of Health and Social Development".
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GBI Research, the leading business intelligence provider, has released its latest report, “Emerging
Market for Clinical Trials in Russia - Curbs on New Drug Approval Timelines and Registration Fees Encourage the Emergence of a Major Global Player” that provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Russia. The report provides a comprehensive insight of reasons for outsourcing clinical trials to Russia.
The opinion of industry experts has been incorporated in various parts of the report to emphasis the
importance of various factors which affects the clinical trial market scenario in Russia.
The clinical trial market in Russia is one of the most important parts of the global clinical trial
market. Russia has got the population and the prevalence of diseases which cater as a good pool
of subjects in the clinical trials scenario. The high quality of the regulations followed in clinical trials in Russia leads to better optimization of clinical trials. The speed of clinical trials conducted in Russia is high mainly because of the high patient recruitment rate. The number of clinical trials conducted in Russia by foreign sponsors has tripled in the last decade. The quality of the clinical trials in Russia has been accepted by regulatory agencies such as the FDA and the EMA. The FDA approved 19 drugs in 2007with the data for six of these drugs coming from Russian sites. It was also observed by FDA inspection that Russia has good quality of investigators leading to low deficiency rate. Russia has caught the imagination of Big Pharma and this has led to huge investment by major pharmaceutical companies. There is improvement in the infrastructure for the conduction of clinical trials in Russia.
This report is built using data and information sourced from proprietary databases, primary and
secondary research and in house analysis by GBI Research’s team of industry experts.
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http://www.gbiresearch.com/Report.aspx?ID=Emerging-Market-for-Clinical-Trials-in-Russia-Curbs-on-New-Drug-Approval-Timelines-and-Registration-Fees-Encourage-the-Emergence-of-a-Major-Global-Player&Title=Pharmaceuticals_and_Healthcare&ReportType=Industry_Report
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