Nana U. Bekhorashvili, Elena R. Zakharochkina, Ekaterina M. Grigorevskikh, Arus G. Margaryan, Diana I. Sologova

Abstract

This study aimed at defining the peculiarities of immunobiologicals’ circulation in the ‎Russian pharmaceutical market. In the system analysis of the regulatory framework for the ‎national regulation of medicine circulation for 2014–2019, it has been revealed that the ‎requirements set to immunobiologicals were stricter. The comprehensive combination of the ‎pharmaceutical and sanitary-epidemiological regulation for all circulation subjects has been ‎an important feature. Since the end of 2019, manufacturers and holders of registration ‎certificates must comply with a new procedure for introducing vaccines, toxoids, toxins, ‎serums, immunoglobulins, and allergens into circulation. The Russian market of the basic ‎groups of immunobiologicals has largely depended on the development of the domestic ‎pharmaceutical industry, regulated by the Ministry of Industry and Trade of Russia‎‎‎‎.