Registration of pharmaceuticals: expert assessment of modification the standard documentation

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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

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Copyright (c) 2015 Картавцова Т.В., Фомина А.В.

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