Refinement of Drug Regulation and Russian Pharmaceutical Export

Abstract

Strategy on development of the pharmaceutical industry for the period up to 2030 (Pharma-2030 Strategy), adopted in the Russian Federation this year, includes tasks to further saturate the national market with domestic medicines and to “realize the export potential of the pharmaceutical industry”. National drug regulation has a significant stimulating effect on the export of medicines. To identify the most important elements of this regulation related to the development and maintenance of sustainable pharmaceutical export, different aspects of national drug regulatory systems were studied. Countries belonging to different segments of the global pharmaceutical export market were included in the research. The results of the analysis of drug regulation in top export countries were published earlier. This article presents the results for pharmerging countries with a fastgrowing pharmaceutical sector and formulated common strategies for these countries that are aimed at achieving leadership positions of the national pharmaceutical industry in both the domestic and foreign markets. Several measures have been proposed for inclusion in the implementation plan for the Pharma-2030 Strategy, which, in our opinion, will contribute to achieving the goals set both to stimulate exports and to saturate the Russian market with domestic medicines.