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The article describes the landmarks of control and licensing system development for the purpose of drug evaluation, marketing authorization and circulation in Russia. The need for the development of a state institution for performing expert evaluation of medicines was satisfied in 1990 by the establishment of the All-Soviet Union Scientific Centre for Expert Evaluation of Medicines (renamed in 1992 as the Russian State Centre for Expert Evaluation of Medicines - RSCEEM). The activities of the Centre included expert evaluation of all documents for new pharmaceutical products; organization and monitoring of clinical trials, as well as the assessment of their results; development of the recommendations regarding marketing authorization and medical use of new medicines. It also exercised the functions of the Federal Centre for Adverse Drug Reaction Study. RSCEEM became a basis for modern currently functioning Scientific Centre for Expert Evaluation of Medicinal Products».