Some issues of non-compliance with national legislation and good clinical research practices

Radaev S. M., Volchkov D. A.

The article is devoted to the analysis of the national legislation of Russia on the regulation of the circulation of medicines, international legal norms governing the European and American market of medicines; reviewing the norms of good clinical and industrial practice; comparing the norms regulating the markets of Russia and Europe-USA. The article addresses the issue of non-compliance with the requirements of the national legislation of Russia and the requirements of good clinical practice in terms of the exposure of research subjects when conducting a registration study of a medicinal product.

Keywords:pharmaceutical law, good clinical practice, drug registration trials, GCP, GLP