Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (SCEEMP) performs evaluation of Russian-produced and imported medicinal products.
The 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 with the aim of ensuring their compliance with the quality, safety, and efficacy requirements (see ‘Evaluation’).
The SCEEMP employs highly qualified professionals in medicine, pharmacology, toxicology, chemistry, biology, and other scientific fields, whose professional responsibilities are guided by the Russian national 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.
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Virtual Tour of the Pharmacopoeial Reference Standards Department
Virtual Tour of the Laboratory of Vitamins, Hormones and Synthetic Analogues
Virtual Tour of the Spectroscopic Methods Laboratory
Virtual Tour of the Laboratory of Herbal and Homeopathic Medicinal Products
Mission
The SCEEMP strives to contribute to the provision of the Russian healthcare system with high-quality, safe, and efficacious medicinal products.
Main functions:
- pre-authorisation evaluation of Russian-produced and imported medicinal products (including human cell-based medicinal products);
- elaboration of modern scientific and methodological principles of medicine evaluation;
- contribution to standards-setting for safety, efficacy, manufacturing conditions, and quality control of medicinal products;
- standardisation of medicinal products (elaboration of pharmacopoeial monographs and general chapters, certification of pharmacopoeial reference standards);
- research and development;
- training and education;
- support of medical and pharmaceutical innovations throughout their lifecycle, including practical implementation, as part of the Federal Project ‘Medical Science for People’.
The SCEEMP has two Testing Centres, which include 20 laboratories in total:
- Testing Centre for Medicinal Products Quality Control—13 laboratories;
- Testing Centre for Biological Products Quality Control—7 laboratories.
The SCEEMP performs over 10,000 laboratory evaluations annually.
The laboratories have an extensive inventory of modern measuring instruments and equipment.
The Testing Centre for Medicinal Products Quality Control is included in the List of the WHO Prequalified Quality Control Laboratories and had an associate member status (since 2011) in the General European Network of Official Medicines Control Laboratories (GEON) of the European Directorate for the Quality of Medicines & Healthcare (EDQM).