Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) performs evaluation of Russian-produced and imported medicinal products.
The FSBI ‘SCEEMP’ performs different types of evaluation in the context of clinical trial applications, marketing authorisation applications, variation applications, for all medicinal products marketed in Russia, verifying their compliance with the quality, safety, and efficacy requirements (see ‘Evaluation’).
The FSBI ‘SCEEMP’ employs highly-qualified professionals in medicine, pharmacology, toxicology, chemistry, biology, and other scientific fields, who, in their professional activities, are guided by and adhere to the Russian laws and regulations on medicinal products, and the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use established by Decisions of the Eurasian Economic Commission Council.
Mission
The FSBI ‘SCEEMP’ mission is to contribute to the provision of the Russian healthcare system with high-quality, safe, and efficacious medicinal products.
Main functions:
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pre-authorisation evaluation of Russian-produced and imported medicinal products (including cell-based medicinal products);
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elaboration of modern scientific and methodological principles of medicine evaluation;
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contribution to standards-setting for safety, efficacy, manufacturing conditions, and quality control of medicinal products;
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standardisation of medicinal products (elaboration of pharmacopoeial monographs and general chapters, certification of pharmacopoeial reference standards);
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research and development;
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training and education;
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support of medical and pharmaceutical innovations throughout their lifecycle, including practical implementation, as part of the Federal Project ‘Medical Science for People”.
The FSBI ‘SCEEMP’ has two Testing Centres within its structure, which include 23 laboratories in total:
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Testing Centre for Medicinal Products Quality Control—13 laboratories
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Testing Centre for Biological Medicinal Products Quality Control—10 laboratories
The FSBI ‘SCEEMP’ performs over 10,000 laboratory evaluations annually.
The laboratories occupy more than 21,000 m2 and have an extensive inventory of modern measuring instruments and equipment.
The laboratories of the Testing Centre for Medicinal Products Quality Control are included in the List of the WHO Prequalified Quality Control Laboratories, and have an associate member status in the General European Network of Official Medicines Control Laboratories (GEON) of the European Directorate for the Quality of Medicines & Healthcare (EDQM).