article
13.11.2017

Nonclinical studies in the Russian Federation

Drug product developers and sponsors face a number of problems when organizing a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centers, complicating adaptation of the available experimental data to domestic legislation.In this article, we discuss these the main regulatory documents in Russia, their compliance with international standards (Good Laboratory Practice), the structure of the responsible authorities, and problems with implementing the regulatory documents. Finally, we discuss the current regulatory trends in Russian nonclinical studies.