Pharmacopoeial standardisation of biological medicinal products: Basic principles for the common pharmaceutical market of the Eurasian Economic Union

INTRODUCTION. The advancement of manufacturing technologies and the expanding range of biological medicinal products (BMPs) and indications for their use necessitate the development of a unified approach to BMP standardisation at both national and regional levels. In the context
of the common pharmaceutical market of the EAEU (EAEU), the requirements for medicinal products should take into account the national pharmacopoeial quality standards, which, in turn, are subject to harmonisation with regional pharmacopoeial standards.

AIM. This study aimed to systematise the requirements for BMPs of the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the EAEU to achieve harmonisation of the national and regional standards.

DISCUSSION. This study analysed special considerations for BMP standardisation in accordance with the national pharmacopoeias of the EAEU Member States. In addition, the study covered the requirements of major international pharmacopoeias and regulatory documents, including those by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Having established the basic principles for formulating the requirements for BMPs within the scope of the Pharmacopoeia of the EAEU, the authors drafted a general chapter for BMPs for the Pharmacopoeia of the EAEU. This draft general chapter introduced a uniform definition of BMPs, taking into account regional and national legislation. The general chapter standardised compendial requirements for different groups of BMPs, highlighting the main considerations for the production (technology) and quality control of intermediates and finished medicinal products. When harmonising the State Pharmacopoeia of the Russian Federation with the requirements of the Pharmacopoeia of the EAEU, the authors outlined the main approaches to BMP standardisation applied by the State Pharmacopoeia of the Russian Federation and made amendments to General Chapter 1.7.1.0010.18 Biological medicinal products of the national pharmacopoeia. In particular, the authors removed the requirements for BMP production that were not universally applicable to all BMPs, along with the lists of mandatory tests for active pharmaceutical substances and finished medicinal products.

CONCLUSIONS. The study systematised the requirements for BMPs outlined in international and regional regulatory documents. The authors drafted the general chapter for BMPs for the Pharmacopoeia of the EAEU and used it in updating General Chapter 1.7.1.0010.18 Biological medicinal products of the State Pharmacopoeia of the Russian Federation. The study also substantiated the approaches to drafting compendial texts (general chapters and monographs) for BMPs.

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