Drug Regulation in Top Exporters of Pharmaceutical Products

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.