Registration of pharmaceuticals: expert assessment of modification the standard documentation
- Authors: Kartavtsova TV1, Fomina AV2
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Affiliations:
- Department of Governmental Regulation of Drug Circulation Ministry of Health of Russian
- Peoples’ Friendship University of Russian
- Issue: No 4 (2015)
- Pages: 36-39
- Section: Articles
- URL: https://journals.rudn.ru/medicine/article/view/2411
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Abstract
Registration of drugs is a key element in the system of state regulation of the pharmaceutical market. This paper discusses the expert assessment of changes to the registration documents for drugs, the basic directions of improvement of the system changes in the regulatory documents.
About the authors
T V Kartavtsova
Department of Governmental Regulation of Drug Circulation Ministry of Health of Russian
Email: KartavcovaTV@rosminzdrav.ru
A V Fomina
Peoples’ Friendship University of Russian
Email: fomina_av@pfur.ru
Department of Public health and hygiene