Biotechnological Medicines in the Russian Pharmaceutical Market: New Pharmacopeia Requirements and the Status of Restrictive Lists

Nana Bekhorashvili; Elena Revovna Zakharochkina; Maria Grigorievna Rayisyan; Rimma Yuiryevna Garankina

doi:10.3889/oamjms.2020.3636

Authors

Nana Bekhorashvili Department of Regulatory Relations on the Circulation of Pharmaceuticals and Medical Products, Sechenov First Moscow State Medical University, Moscow, Russia
Elena Revovna Zakharochkina Department of Regulatory Relations on the Circulation of Pharmaceuticals and Medical Products, Sechenov First Moscow State Medical University, Moscow, Russia
Maria Grigorievna Rayisyan Department of Regulatory Relations on the Circulation of Pharmaceuticals and Medical Products, Sechenov First Moscow State Medical University, Moscow, Russia
Rimma Yuiryevna Garankina Department of Regulatory Relations on the Circulation of Pharmaceuticals and Medical Products, Sechenov First Moscow State Medical University, Moscow, Russia

DOI:

https://doi.org/10.3889/oamjms.2020.3636

Keywords:

biotechnological medicines, biological medicines, 14th edition of the State Pharmacopoeia, interferons, monoclonal antibodies, filgrastim, erythropoietins, DNA vaccines, genetically engineered human insulin preparations, list of vital and essential drugs

Abstract

The study is aimed at identifying the key aspects of the national pharmacopeial regulation of the circulation of biotechnological medicines in the Russian pharmaceutical market and at studying the range of major groups based on the analysis of restrictive lists. The systematic analysis of the new national State Pharmacopeia has resulted in the identification of the newly-introduced general pharmacopeia monographs on biotechnological medicines and their groups, establishing the monographs on specific items, and the generalization of the basic conditions for ensuring quality in production. The content analysis of the restrictive lists has made it possible to determine the vital and most important items by the main groups of biotechnological medicines.

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