The Institute of Pharmacopoeia works out pharmacopoeial requirements for the quality of medicinal products for human use—at the national level (State Pharmacopoeia of the Russian Federation) and the regional level (Pharmacopoeia of the Eurasian Economic Union).
In order to align the pharmacopeial requirements with the global pharmacopoeial quality standards for medicines, the Institute of Pharmacopoeia conducts a comprehensive analysis of the best practices and approaches of the world’s leading pharmacopoeias and maintains close cooperation with foreign partners.
Main activities of the Institute of Pharmacopoeia and Medicinal Product Standardisation
Determination of short- and long-term development areas and prospects for the State Pharmacopoeia of the Russian Federation.
Ensuring the harmonisation of the Russian Pharmacopoeia with the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), leading world pharmacopoeias, and other international guidelines.
Participation in the development of guidelines, recommendations, and other documents on medicinal product standardisation and quality control.
Main objectives of the Institute of Pharmacopoeia and Medicinal Product Standardisation
Elaboration and revision of general monographs/chapters and individual monographs, according to the approved time schedule.
Participation in the development and updating of the Pharmacopoeia of the Eurasian Economic Union.
Coordination of activities of the FSBI ‘SCEEMP’ Pharmacopoeial Committee and the expert panels of the Institute of Pharmacopoeia and Medicinal Product Standardisation.
Preparation of meeting materials and organisation of meetings of the Russian Pharmacopoeia Council of the Ministry of Health of Russia.
Structure of the Institute of Pharmacopoeia and Medicinal Product Standardisation
Division for Process Organisation and Methodological Support
Determination of medicinal product monographs to be included in the State Pharmacopoeia of the Russian Federation, analysis of the relevance of and necessity for the development of general and individual monographs for groups of medicinal products or individual products, based on the number of such products available on the market and number of nonconformities identified during medicinal product quality control.
Monitoring of the requirements of the leading world pharmacopoeias, including approaches and innovations used.
Coordination of digitalisation of monograph development processes, in cooperation with the other divisions.
Control over the fulfilment of deadlines for monograph development.
Registration and analysis of proposals on the contents of general and individual monographs.
Division for elaboration of pharmacopoeial monographs on biological medicinal products
Elaboration of general and individual monographs on biological medicinal products and biological test methods to be included in the State Pharmacopoeia of the Russian Federation.
Updating the structure and contents of the Russian Pharmacopoeia general and individual monographs for biological medicinal products and biological test methods to harmonise them with the leading pharmacopoeias.
Participation in the elaboration of general and individual monographs on biological medicinal products and biological test methods to be included in the Pharmacopoeia of the Eurasian Economic Union.
Development of guidelines and recommendations on standardisation and quality control of biological medicinal products and biological test methods.
Division for elaboration of pharmacopoeial monographs on herbal and homeopathic medicinal products
Elaboration of general and individual monographs on herbal and homeopathic medicinal products to be included in the State Pharmacopoeia of the Russian Federation.
Updating the structure and contents of the Russian Pharmacopoeia general and individual monographs on herbal and homeopathic medicinal products.
Participation in the elaboration of general and individual monographs on herbal and homeopathic medicinal products to be included in the Pharmacopoeia of the Eurasian Economic Union.
Development of guidelines and recommendations on standardisation and quality control of herbal and homeopathic medicinal products.
Division for elaboration of pharmacopoeial monographs on chemical, synthetic medicinal products, and medicinal products of mineral origin
Elaboration of monographs on chemical, synthetic medicinal products, and medicinal products of mineral origin to be included in the State Pharmacopoeia of the Russian Federation.
Updating the structure and contents of the Russian Pharmacopoeia general and individual monographs on chemical, synthetic medicinal products, and medicinal products of mineral origin.
Participation in the elaboration of general and individual monographs on chemical, synthetic medicinal products, and medicinal products of mineral origin to be included in the Pharmacopoeia of the Eurasian Economic Union.
Development of guidelines and recommendations on standardisation and quality control of chemical, synthetic medicinal products, and medicinal products of mineral origin.
Highlights
Preparation of general and individual monographs to be included in the State Pharmacopoeia of the Russian Federation, XV edition.
Certification of the first Russian pharmacopoeial chemical reference substances, expansion of the Russian collection of pharmacopoeial reference standards.
Improvement of the monograph development efficiency through the establishment of the FSBI ‘SCEEMP’ Pharmacopoeial Committee and the expert panels of the Institute of Pharmacopoeia and Medicinal Product Standardisation that engage over 150 representatives from the academia and industry.
Cooperation with experts from the Eurasian Economic Union (EAEU) member states in the development of monographs for the EAEU Pharmacopoeia and coordination of the EAEU Pharmacopoeia Council activities.
Establishment and updating of the State Pharmacopoeia Forum (http://pharmacopoeia.regmed.ru/). Participation in its development.