Navigating through the Clinical Trial Authorization Process in Russia

Regulatory:

Navigating through the Clinical Trial Authorization Process in Russia

Countries of Eastern Europe, specifically Russia, have become an increasingly attractive venue for conducting clinical trials in the eyes of western pharmaceutical companies. Sponsors consider Russia as an attractive study venue due to the countries higher enrollment and patient retention rates and lower overall cost. This paper outlines the regulatory requirements for obtaining regulatory approval for clinical studies and addresses certain practical aspects of regulatory submissions in Russia.