Harmonisation of Russian and Foreign Pharmacopoeial Standard Terms

Abstract

Open borders of the present-day pharmaceutical market call for improvement and harmonisation of the legal basis underlying drug circulation. Part of the overall process of harmonisation of regulatory requirements is the alignment of the terminological systems used in Russian and foreign pharmacopoeial and marketing authorisation-related activities. The aim of the study was to compare the Standard Terms database of the European Pharmacopoeia and corresponding documents of the Eurasian Economic Union. The paper describes the structure of the Standard Terms database of the European Pharmacopoeia and the Nomenclature of Dosage Forms adopted in the Eurasian Economic Union. It compares classifications applied at different levels of the pharmaceutical dosage form hierarchy. The paper summarises characteristics of the basic and additional elements forming the name of a pharmaceutical dosage form and cites some specific cases to illustrate the modern approaches to inventing such names. It demonstrates a high degree of conformity between the terminological systems and potential for their further convergence. The data provided can be used in the elaboration of pharmacopoeial texts for the State Pharmacopoeia of the Russian Federation, in the development of medicines, their authorisation, as well as for further convergence of the names of dosage forms used in the European and Eurasian markets.

Keywords

• harmonisation
• standard terms
• nomenclature of dosage forms
• reference data
• classifier