Academic journals FSBI «SCEEMP»


In the XXI century, the national security doctrine has become the cornerstone of Russian policy. The approved development strategy is reflected in the following documents: the Strategy for the Development of the Russian Pharmaceutical and Medical Industry until 2020 and the Federal Target Programme for the Development of the Russian Pharmaceutical and Medical Industry until 2020 and Beyond. An important part of the programme is the «Development of regulatory approaches to the sphere of medicinal products circulation» section devoted to the harmonization of legal and regulatory framework with international standards for medicinal products circulation.

The Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation (FSBI «SCEEMP») has been striving to improve the regulatory and methodological basis for expert evaluation of APIs and pharmaceuticals, in accordance with the regulations of the Ministry of Health of the Russian Federation. Thanks to a highly specific profile of its activities, the FSBI «SCEEMP» was able to accumulate a considerable amount of unique and objective data.

It should be mentioned that the scientific status obliges the FSBI «SCEEMP» team to continuously come up with practical and intellectual initiative that consists in, but is not limited to, contributions to scientific periodicals. Considering the diversity and the amount of relevant information generated monthly by its employees, the FSBI «SCEEMP» quarterly publishes three independent scientific and practical journals:

  • Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products,
  • Biopreparations. Prophylaxis, diagnosis, treatment,
  • Safety and risks of pharmacotherapy.

Research and practice journal
«Safety and Risk of Pharmacotherapy»

Research and practice journal

Research and practice journal
«Scientific centre for expert evaluation of medicinal products bulletin»

The focus of the scientific and practical journal Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products is on expert evaluation and marketing authorization of medicines, as well as assessment of preclinical and clinical trials results. It is a platform for discussions related to modern chromatography and NMR spectroscopy methods used to identify pharmaceutical substances and chemical impurities, and to the significance of dissolution kinetics testing for solid dosage forms, and microbiological quality testing for antimicrobials.

Clinical pharmacology is represented by the articles devoted to improving the system used for the medicines safety information evaluation in clinical trials, as well as to determining the content of clozapine in plasma by tandem mass spectrometry.

Issues related to the development of the State Pharmacopoeia of the Russian Federation are reflected in the publications dealing with elaboration of quality requirements and analytical methods for pharmacopoeial herbal reference standards, and modern approaches to harmonization of quality standards for herbal raw materials.

Pharmacoeconomic issues are discussed in the article on the "cost of illness" analysis, which is an essential method of pharmacoeconomic studies at various levels of the health care system.

We hope that this issue of the journal gives the reader a general idea of ​​the activities of our institution in the development of scientific and methodological approaches to a comprehensive examination of the quality, efficacy and safety of medicines, as well as the harmonization of the regulatory framework. with international standards for the circulation of medicines.

The research and practice journal Safety and Risks of Pharmacotherapy is a direct successor of the journal Safety of Medicines and Pharmacovigilance published by our institution until 2011. For many years, our journal has been the only scientific periodical in Russia, specializing in medicinal products safety concerns.

The journal is addressed to a wide range of physicians, scientists, professionals in the pharmaceutical industry and regulatory bodies. We are open for cooperation; and all like-minded contributors are welcome.