National regulations of the Russian Federation
Federal Laws
- Federal Law «On Circulation of Medicines» No. 61-FZ, 12 April 2010
- Federal Law On Public Health Protection in the Russian Federation, No. 323-FZ, 21 November 2011
Government Decrees
- Government Order No. 771 of September 29, 2010 "On Procedure of Import of medicines for medical use into the Russian Federation"
Regulatory Orders
- Order No. 200n dated April 01, 2016 of the Ministry of Health of the Russian Federation On Approval of Rules for Good Clinical Practice
- Annex 13 to Order of the Ministry Ministry of Industry and Trade of the Russian Federation dated 14.06.2013 N 916 (as amended on 18.12.2015) On Approval of Rules for Guidelines for Good Manufacturing Practice for Medicinal Products for Clinical Use
National Standard
- National Standard GOST R ISO 9001—2008 Quality Management Systems
- National Standard of the Russian Federation GOST R 52379-2005 "Good Clinical Practice"
International Standards and Regulations
- ISO 9001-2008 Quality Management Systems
- ICH Guideline for Good Clinical Practice E6
- Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- WHO Guide to Good Storage Practices for pharmaceuticals
- Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use