History

4 June 2002 is the date of the official registration of the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), i.e., the date of the establishment of the legal entity by way of its restructuring.

The first medicines to be subject to evaluation and control in Russia were immunobiological products.

In 1915, the All-Russian Union of Zemstvos established the Central Station for Control of Sera and Vaccines on the basis of the Microbiology Department of the Moscow Higher Education Courses for Women (currently―Pirogov Russian National Research Medical University).

On 29 August 1918, the first record of a tested medicine was made in the vaccine control logbook of the Central Station for Control of Sera and Vaccines. The Station started to control vaccines against enteric infections. This marked the beginning of the official control of immunobiological products in Russia.

The FSBI ‘SCEEMP’ history dates back to January 1919, having undergone a number of mergers, reforms, affiliations, and renamings. At different times, several institutions joined the FSBI ‘SCEEMP’ and were integrated into its structure.

In January 1919, the State Institute for Control of Sera and Vaccines was established by Order of the People’s Commissar of Healthcare, Nikolay Semashko. It was created as a functional unit of the State Institute of Public Health, which incorporated eight biological institutions.

In 1971, the State Institute for Control of Sera and Vaccines was renamed into Tarasevich State Research Institute for Standardisation and Control of Biological Products.

In May 1999, the State Research Institute ‘Scientific Centre for Evaluation and State Control of Medicinal Products’ of the Ministry of Health of the Russian Federation was established.

The oldest available certificate No. 079.024 of 26 May 1999 (terminated on 4 June 2002 due to the reform of the institution), issued by the Moscow Registration Chamber of the Government of Moscow, states that the institute was formed as a result of the merger between:

Research Institute of Traditional Treatment Methods (Traditional Medicine) of the Ministry of Health of the Russian Federation, reg. No. 22876, 11.03.1993,
Applied Research Centre for Control of Adverse Reactions (subordinate to the Ministry of Health), reg. No. 73736, 23.07.1998,
Federal State Research Institute ‘State Research Institute for Standardisation and Control of Medicinal Products’ of the Ministry of Health of the Russian Federation, reg. No. 71031, 06.03.1998,
Russian National Centre for Evaluation of Medicines of the Ministry of Health of the Russian Federation, reg. No. 23978, 19.04.1998.

The new organisation was created with the main purpose of consolidating the system of state control over the quality, efficacy, and safety of both Russian-produced and imported medicinal products.

In 2002, the Federal State Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation was formed by the merger between the State Research Institute ‘Scientific Centre for Evaluation and State Control of Medicinal Products’ of the Ministry of Health of the Russian Federation and the Federal State Institution ‘Analytical Control Centre for Medicines and Medical Devices Quality Control’ of the Ministry of Health of the Russian Federation.

In 2004, the Federal Service for Supervision of Healthcare and Social Development (Roszdravnadzor) was established, following the administrative reform of the federal agencies. The Federal State Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ was handed over to Roszdravnadzor as one of its subordinate agencies (FSI ‘SCEEMP’ of Roszdravnadzor).

In August 2010, the FSI ‘SCEEMP’ of Roszdravnadzor was transformed into the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ and put under control of the Ministry of Health and Social Development of the Russian Federation.

In December 2010, Tarasevich State Research Institute for Standardisation and Control of Biological Products was included into the FSBI ‘SCEEMP’ structure as one of its Centres.

In 2012, after the reform of the Ministry of Health and Social Development of the Russian Federation, the FSBI ‘SCEEMP’ got its present name―the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation.

Thus, following a series of reforms, a new agency emerged in the Russian Federation, with unique expertise and mandate in the area of quality, efficacy, and safety control of medicinal products, including immunobiologicals.

Many prominent Russian scientists and experts were among the leaders of the FSBI ‘SCEEMP’: Vladimir Fisenko, Academician of the Russian Academy of Sciences; Ram Petrov, Academician of the Russian Academy of Sciences and the Russian Academy of Agricultural Sciences; Vladimir Gerasimov, Doctor of Medical Sciences, Professor; Sergey Budanov, Candidate of Medical Sciences; Alexander Mironov, Doctor of Medical Sciences, Professor; Yury Olefir, Doctor of Medical Sciences.

Since October 2021, Valentina Kosenko, Candidate of Pharmaceutical Sciences, has been General Director of the FSBI ‘SCEEMP’.