Legislative changes in the State Pharmacopoeia of the Russian Federation in the last two editions (XIV and XV editions)

Abstract

A pharmacopoeia is a country's regulatory requirement that sets standards and mandatory requirements for the quality of drugs, starting materials used for drug development, and various pharmaceutical formulations or preparations. The requirements and recommendations set out in it are mandatory for all organizations in the country involved in the production, storage, sale and use of medicines. For violation of the rules recorded in the document, a legal entity or individual faces criminal liability. The article provides a brief analysis of the Russian Federation State Fund over the past 5 years. The State Pharmacopoeia of the Russian Federation XIV and XV editions, as well as the general pharmacopoeial monographs and pharmacopoeial monographs included in them, were analyzed. Taking into account the fact of harmonization of pharmacopoeias, the international pharmacopoeia was also analyzed. Of the 313 General Pharmacopoeial Articles (GPM) that are included in the State Pharmacopoeia of the XV edition, 102 GPM are being introduced into domestic pharmacopoeial practice for the first time. Of the 564 pharmacopoeial monographs (PS), which are approved as part of the main part of the State Pharmacopoeia of the XV edition, 253 PH are being introduced into domestic pharmacopoeial practice for the first time. The pharmaceutical substances included in the XV edition of the State Pharmacopoeia of the Russian Federation mainly establish requirements for the quality of pharmaceutical substances of chemical, synthetic and mineral origin. Pharmacopoeias make it possible to optimize the interaction between manufacturers and regulatory authorities: to facilitate the preparation and assessment of submitted documents and to increase the uniformity of decisions made during regulation. This can save time and resources for manufacturers and regulators.