Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (SCEEMP) was established pursuant to the provisions of Article 15 of Federal Law No. 61-FZ ‘On Circulation of Medicines’ dated 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.
SCEEMP performs medicinal product evaluation as part of the procedures for medicinal product authorisation, confirmation (renewal) of marketing authorisation, approval of variations to marketing authorisations, 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 dated 3 November 2016, as well as the following Decrees of the Government of the Russian Federation:
- Decree No. 593 of the Government of the Russian Federation ‘On Specific Aspects of Regulation of Medicinal Products for Human Use in the Case of Shortage or Risk of Shortage Due to Restrictive Economic Measures Imposed against the Russian Federation’ dated 5 April 2022;
- Decree No. 440 of the Government of the Russian Federation ‘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’ dated 23 March 2022;
- Decree No. 441 of the Government of the Russian Federation ‘On Specific Aspects of Regulation of Medicinal Products for Human Use Intended for Use under Threat of Emergencies, during Actual Emergencies, for the Provision of Medical Care to Persons Affected by Emergencies, for the Prevention of Emergencies, for the Prevention and Treatment of Diseases That Pose a Threat to the Public, and Diseases and Injuries Resulting from Exposure to Adverse Chemical, Biological, and Radiation Factors’ dated 3 April 2020, etc.
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 scientific and technological innovations, responsibility of the Centre and the experts for the performed 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 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.