State Pharmacopoeia of the Russian Federation Edition XV: Development Priorities

Abstract

INTRODUCTION. Regular reviews of the current portfolio of general chapters and monographs are essential to ensure the well-balanced development of the State Pharmacopoeia of the Russian Federation (Ph. Rus.) in line with the priorities of the national healthcare system.AIM. This study aimed to identify the most promising areas for further Ph. Rus. development through an analysis of recent legislative changes in Russia and the current compendial portfolio.DISCUSSION. This article compares Ph. Rus. editions XIV and XV, analyses the key features and structure of edition XV, and reviews amendments to the regulations governing the Ph. Rus. publication. The current compendial portfolio is dominated by monographs on chemical active substances; it also includes a substantial number of monographs on herbal drugs and herbal drug preparations. Noteworthy, edition XV is the first Ph. Rus. edition to include a separate section dedicated to monographs on excipients necessary for the development of pharmacy compounding. Moreover, this article analyses the coverage of active substances that are used for the production of listed vital and essential medicines.CONCLUSIONS. The authors outlined the priority areas for the development of quality standardisation. The Ph. Rus. should continue developing monographs on active substances that are used for the manufacturing and compounding of listed vital and essential medicines. In addition, the coverage of herbal drugs should be expanded. The Ph. Rus. should develop monographs on excipients that are used for the manufacturing and compounding of medicinal products. Finally, the Ph. Rus. should complete the development of requirements for biological medicinal products and relevant test methods.