A Clinical Trial wrapped in a mystery, inside an enigma.

  • by: |
  • 03/15/2012
You mean central planning doesn’t work?
Russia: Russian Companies Receive Lowest Number of Permits for Clinical Research in Seven Years 
Russian companies have received the lowest number of permits for clinical research in seven years, according to a report from Remedium. In 2011, the Ministry of Public Health issued 571 permits for clinical studies, of which 369 were for multicenter studies (an increase of 49% from 2010), and 117 for local studies (a decrease of 27% from 2010).
The share of research by Russian sponsors was below average for the last seven years, with domestic producers receiving 14.1% of permissions for drugs research testing—against the seven-year average of 20.6%. According to the report, the number of local studies has fallen following the 1 September 2010 "law on treatment of drugs", which specified that local studies be included in the registration of medicines, meaning that Russian companies must apply for a drug's registration and pay a state fee before testing. There is no such requirement for foreign companies in Russia.
The Federal Antimonopoly Service (FAS) is currently preparing an amendment to the law proposing that the requirement to register be cancelled. They are also proposing to cancel the obligation for foreign companies in Russia to conduct local research if not including the country in a multi-center trial.
Significance: Russia's healthcare and pharmaceutical industry is currently going through regulatory changes that aim to simplify the registration process and speed market entry for drugs, among other goals. The report will come as a setback to Russia's efforts to expand the pharmaceutical industry and stimulate domestic manufacturers. The changes proposed by the FAS are likely to form a part of the regulatory reforms that are currently being formulated.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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