State Pharmacopoeia of the Russian Federation: Drug Standardization under Development of a Common EAEU Pharmaceutical Market

INTRODUCTION. The State Pharmacopoeia of the Russian Federation (SP RF) is the key set of mandatory requirements for the drug quality. Its development vectors are not limited to improving the legal framework but also take into account the key trends of the regional pharmacopoeia — the Pharmacopoeia of the Eurasian Economic Union (Ph. EAEU). Regular analysis of the current state of the pharmacopoeia and identification of the most promising and relevant growth vectors is a prerequisite for ensuring sustainable and consistent improvement of pharmacopoeial approaches and requirements.

AIM. This study aimed to identify potential growth vectors of the SP RF, edition XV, given the development of a common pharmaceutical market within the EAEU.

DISCUSSION. We analyzed key changes in the legal framework that took place at the national and regional (EAEU) levels, including the updated Procedure for developing SP RF monographs that explicitly considers Ph. EAEU requirements. The study also examined the Development strategy for EAEU Pharmacopoeia that outlines the basic principles, the Strategy objective, the stages of its implementation, and the necessary measures. The document includes relevant data on the provisions of SP RF, edition XV, and offers promising growth vectors for compendial requirements.

CONCLUSIONS. Considering the main trends in the development of the EAEU Pharmacopoeia, the following growth vectors for pharmacopoeial quality standards can be identified: updating the nomenclature and content of general pharmacopoeial monographs for medicinal products and their dosage forms; extending harmonization to align approaches with the pharmacopoeias of states friendly to the Russian Federation; implementing instrumental, accurate, and selective methods and techniques, in order to replace animal testing as well.

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