Main functions and objectives:
Performing evaluation of medicinal product quality and benefit/risk ratio, as requested by the Ministry of Health of Russia, for the purpose of:
– marketing authorisation,
– confirmation of marketing authorisation,
– assessment of variations to registration dossiers,
– inclusion of active substances in the National Register of Medicinal Products,
– review of clinical trial applications,
– assessment of medicines interchangeability.
Provision of scientific, information, and methodological support in the evaluation of medicinal product quality and benefit/risk ratio.
Improvement of scientific and methodological approaches to the evaluation of pharmaceutical, preclinical, and clinical data.
Contribution to the elaboration of national and international regulations, standards, and guidelines on medicine standardisation and quality/efficacy/safety control.
Participation in the preparation of the official Ministry of Health communications on medicines.
Holding educational events (within MPEC competence) to train professionals in medicine regulation, including training events for FSBI ‘SCEEMP’ specialists.
MPEC structure
Division No. 1 for Medicinal Product Efficacy and Safety Evaluation
Division No. 2 for Medicinal Product Efficacy and Safety Evaluation
Division No. 3 for Medicinal Product Quality Evaluation
Division No. 4 for Medicinal Product Quality Evaluation
Highlights
Since the latter half of 2019, a lot of work has been done in pursuance of the Eurasian Economic Union (EAEU) rules and regulations. The full transition to the EAEU regulations is projected for 2025. By that time, the registration dossiers of all medicines authorised according to the national Russian procedure will have to be brought in line with the new requirements.
The Centre for Medicinal Products Evaluation and Control takes part in the elaboration of the Eurasian Economic Commission (EEC) legal documentation which supports the EAEU regulatory framework. The Centre prepares materials for consideration by the EEC Expert Committee on Medicinal Products on the selection of reference medicinal products, acceptability of biopharmaceutics classification system (BCS)-based biowaivers, etc. Experts contribute to the elaboration of the Russian Pharmacopoeia and the EAEU Pharmacopoeia.
During the novel coronavirus (COVID-19) pandemic, experts put a lot of effort to increase availability of high-quality, efficacious, and safe medicines for hospital and out-patient treatment of COVID-19 of different severity (in accordance with Decree of the Government of the Russian Federation No. 441 of 3 April 2020).
Due to the restrictive economic measures imposed against Russia, and the risks of medicine shortages, the Centre has adjusted its daily activities in accordance with the requirements of Decrees of the Government of the Russian Federation No. 440 of 23 April 2022 and No. 593 of 5 April 2022.
The Centre employs highly-trained professionals who take qualification renewal examinations every five years and undergo certification by a special commission of the Ministry of Health of Russia. The Centre’s staff include 2 holders of post-doctoral degrees in Medicine, 1 holder of a post-doctoral degree in Pharmaceutical Sciences, 16 PhD graduates in Medicine, 7 PhD graduates in Pharmaceutical Sciences, 1 PhD graduate in Biology, and 1 PhD graduate in Chemistry.