FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
About Scientific Centre for Expert Evaluation of Medicinal Products

About Us

Иллюстрация 1

The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation (FSBI “SCEEMP” of the Ministry of Health of the Russian Federation) is a budgetary organisation acting independently from developers and manufacturers of pharmaceuticals. The FSBI “SCEEMP” of the Ministry of Health of the Russian Federation carries out evaluation of medicines according to the principle laid out in Federal Law No. 61-FZ “On drug circulation”.  Evaluation of medicinal products is conducted exclusively for the Ministry of Health of the Russian Federation as part of a testing assignment.

The Ministry of Health of the Russian Federation uses expert opinions issued by the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation as the basis for granting approval for clinical trials and marketing authorisation for medicines.

 

Main Task

The FSBI “SCEEMP of the Ministry of Health of the Russian Federation is a leading organisation in the field of expert evaluation of medicinal products produced both in Russia and abroad. Specialists of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation perform different types of evaluation in the context of the following regulatory procedures: approval of clinical trials, granting marketing authorisations, and approval of post-marketing changes to already authorised medicines.  Experts of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation test medicinal products for quality and potential benefit for patients.Иллюстрация 2

The laboratories of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation are equipped with the state-of-the-art laboratory equipment for evaluation of medicinal products quality. The laboratory facilities are upgraded annually. This allows us to perform laboratory evaluation of innovative medicinal products developed on the basis of modern biomedical technologies, including cell-based technologies.

 

Mission

According to its role within the state regulatory system, the mission of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation is to facilitate provision of medicinal products of appropriate quality and efficacy that meet pharmaceutical and biological safety requirements, and to ensure supply of the Russian healthcare system with high-quality, safe and efficacious medicines produced either in Russia or abroad.

 

 

Our Team

Evaluation of medicinal products at the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation is performed only by appropriately qualified experts, who have passed professional certification exams of the Ministry of Health of the Russian Federation. Every five years experts have to confirm their qualification and for this purpose they have to take qualification exams (including tests and interviews in their respective professional areas) that are administered by a special commission of the Ministry of Health of the Russian Federation. Any specialist with medical, biological, chemical or pharmaceutical background or a degree in any of these scientific fields may apply for an expert position at the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation.

Expert knowledge of the employees and technical capacities of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation enable development and improvement of approaches to evaluation of medicinal products through scientific research; fulfillment of different testing assignments of the Ministry of Health of the Russian Federation, related to evaluation of medicines; improvement of stakeholders’ competence in the field of drug circulation through educational and training programmes.

In addition to the expert evaluation of medicinal products, the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation is in charge of the following activities:

Иллюстрация 2•        certification of immunobiologicals

•        evaluation of medicinal products safety

•        determination of interchangeability of medicinal products

•        elaboration of monographs

•        expert and analytical support of the State register of medicines

•        organisation of trainings and educational programmes in order to improve professional competence of stakeholders in the field of drug circulation. The trainings cover a wide range of topics, including: the state regulation of drug circulation, GMP, GLP, and GCP requirements

•        scientific work: scientific research, publication of scientific journals, elaboration of monographs and guidelines for optimisation of medicines’ evaluation

•        distribution of industrial reference standards of pharmaceutical substances and strains of microorganisms.

 

Use of Best International Practices

The FSBI “SCEEMP” of the Ministry of Health of the Russian Federation takes advantage of best international practices.

Seven laboratories of the Testing Centre for Evaluation of Medicinal Products’ Quality of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation have the status of “WHO-prequalified Quality Control Laboratories”. These laboratories rely on the WHO recommended quality standards in their everyday activities, and may be commissioned by the UN Agencies to perform testing of medicinal products. There are only two organisations in Russia that have WHO-prequalified quality control laboratories, and the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation is one of them. 

Additionally, four laboratories of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation have been qualified by the EDQM (European Directorate for the Quality of Medicines & HealthCare) through the Mutual Joint Audits (MJAs). This means that the laboratories of the Testing Centre meet the requirements of the European standards.

 

Foreign Partners

The FSBI “SCEEMP” of the Ministry of Health of the Russian Federation represents the Russian Federation in the WHO Programme for International Drug Monitoring. Russia has been participating in this programme since 1997. As part of the programme, the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation, namely the Testing Centre for Expert Evaluation of Medicinal Products’ Quality, is entitled to provide individual case safe reports (ICSR) generated in Russia to the WHO Collaborating Centre for International Drug Monitoring (UMC) on a regular basis (at least every 3 months). 

Experts of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation, involved in elaboration of monographs, cooperate closely with their colleagues from the WHO International Pharmacopoeia, regional European Pharmacopoeia, national pharmacopoeias of the USA, the UK, France, Japan, Ukraine, the Republic of Belarus, the Republic of Kazakhstan and other countries. Such cooperation contributes to the harmonisation of the Russian and international requirements for the quality of medicines.

The FSBI “SCEEMP” of the Ministry of Health of the Russian Federation participates in the work of the European Economic Union, namely in the formation of the single market of medicinal products. 

At the end of 2016 a Memorandum of Understanding was signed between the National Regulatory Authorities of Russia and the Republic of Cuba. The cooperation between the Centre for State Control of Medicines of the Republic of Cuba and the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation is maintained mainly in the sphere of regulation of drug circulation and support of projects involving transfer of technologies.

 

Contacts

Yuri Olefir – General Director of the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation, Doctor of Medical Sciences.

Olga Gubareva – Head of the International Cooperation Department, tel. +007 (495) 234 61 04 ext. 63 22, e-mail: Goubareva@expmed.ru

Oxana Chernysheva – Press secretary, e-mail: press@expmed.ru.

 
 
Petrovsky boulevard 8, bld. 2, Moscow 127051

 
 





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