Drug Regulation in Top Exporters of Pharmaceutical Products
https://doi.org/10.21686/2073-1051-2023-3-108-136
Abstract
This year, the Russian Federation adopted the Strategy for the Development of the Pharmaceutical Industry for the Period until 2030. The document sets the task of ensuring the production in the country of medicines that are competitive in the domestic and foreign markets, and “realizing the export potential of the pharmaceutical industry.” A feature of the pharmaceutical industry is the significant impact of various aspects of drug regulation on exports of medicines. The purpose of the study is to make an analysis of the experience of foreign countries and to identify the most important elements of drug regulation that contribute to the formation and development of sustainable export of medicines taking in the account the existing oligopoly structure of the export segment of the global pharmaceutical market. Considering the volume and diversity of the data obtained, the study was divided into two parts: an analysis of drug regulation in countries that are leaders in pharmaceutical export and in countries that are called pharma emerging markets. This article examines the features of export of pharmaceutical products and drug regulation, in general, provides an analysis of top exporters and demonstrates the main factors associated with successful pharmaceutical export, and shows current trends being taken by drug regulation authorities to maintain leadership in this area. The identified patterns and regulatory solutions can be used to solve the problems of regional markets at the national level.
About the Authors
Z. A. Aladysheva
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation (Sechenovskiy University)
Russian Federation
Russian Federation
Aladysheva Zhanna A., Cand. Sc. (Med), Associate Professor
8, Building 2, Trubetskaya Str., Moscow, 119048
V. V. Beregovykh
Federal State Budget Organization “Russia Academy of Sciences”
Russian Federation
Russian Federation
Beregovykh Valery V., Academician of RAS, Dr. Sc. (Tech), Professor, Vice-Secretary of RAS Division for Medical Sciences, Head of department
14, Leninskiy Av., Moscow, 119991
A. P. Meshkovskiy
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation (Sechenovskiy University)
Russian Federation
Russian Federation
Meshkovskiy Andrei P., Associate Professor
8, Building 2, Trubetskaya Str., Moscow, 119048
N. V. Pyatigorskaya
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation (Sechenovskiy University)
Russian Federation
Russian Federation
Pyatigorskaya Natalia V., Corresponding Member of RAS, Dr. Sc. (Pharm), Professor, Head of Department
8, Building 2, Trubetskaya Str., Moscow, 119048
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Review
For citations:
Aladysheva Z.A., Beregovykh V.V., Meshkovskiy A.P., Pyatigorskaya N.V. Drug Regulation in Top Exporters of Pharmaceutical Products. Federalism. 2023;28(3):108-136. (In Russ.) https://doi.org/10.21686/2073-1051-2023-3-108-136
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