Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) was established pursuant to the provisions of Article 15 of the Federal Law No. 61-FZ ‘On Circulation of Medicines’ of 12 April 2010, and is the only expert body in Russia entrusted by the Ministry of Health of the Russian Federation to perform evaluation of clinical trial applications and marketing authorisation applications for medicinal products.
The FSBI ‘SCEEMP’ performs medicinal product evaluation as part of the procedures for medicinal product authorisation, confirmation (renewal) of marketing authorisation, variations to marketing authorisation, and other procedures related to medicinal product authorisation, as laid down in the ‘Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use’ established by Decision No. 78 of the Eurasian Economic Commission Council of 3 November 2016, as well as the following Decrees of the Government of the Russian Federation:
- Decree of the Government of the Russian Federation No. 593 ‘On Special Considerations Relating to Medicinal Products Circulation in the Case of Shortage or Risk of Shortage of Medicinal Products Due to Restrictive Economic Measures Imposed against the Russian Federation’ of 5 April 2022;
- Decree of the Government of the Russian Federation No. 440 ‘On Adoption of Specific Requirements for Variations to Marketing Authorisations in the Case of Shortage or Risk of Shortage of Medicinal Products Due to Restrictive Economic Measures Imposed against the Russian Federation’ of 23 March 2022;
- Decree of the Government of the Russian Federation No. 441 ‘On Special Considerations Relating to Circulation of Medicinal Products Intended for Use in Likely or Actual Emergencies, Delivery of Emergency Health Care, Prevention of Emergencies, Prevention and Treatment of Diseases That Pose a Threat to the Public as well as Diseases and Injuries Caused by Exposure to Adverse Chemical, Biological, Radiation Factors’ of 3 April 2020, etc.
The FSBI ‘SCEEMP’ performs about 10,000 evaluations of medicinal product quality, safety, and efficacy, annually.
Principles of Evaluation
The evaluation of medicinal products is based on the principles of legality, respect for the rights and freedoms of the person and the citizen, respect for the rights of legal entities, impartiality of expert conclusions, objectivity, comprehensiveness, and completeness of studies conducted using modern scientific and technological developments, responsibility of the Centre and the experts for the performance and quality of evaluation.
Main Types of Scientific Evaluation
1. Evaluation of clinical trial applications for medicinal products, including applications for international multicentre clinical trials and post-authorisation clinical trials.
2. Evaluation of quality control test methods described in submissions for medicinal products for human use (finished pharmaceutical products and active pharmaceutical ingredients intended for sale) as well as laboratory testing of medicinal product samples using the above methods.
3. Evaluation of the risk/benefit ratio of medicinal products.