Features of production and registration of BCPs in Russia

Biomedical cell products (BCPs) are a new class of promising medical products that require mandatory state registration and study of efficacy and safety at the stage of preclinical research. This article reviews the literature data on BCPs and cell therapy, discusses aspects of their development and conducting of preclinical and clinical studies, and describes the three main types of BCPs approved in the Russian Federation. On January 1, 2017, Federal Law No. 180-FZ "On Biomedical Cell Products" was adopted to implement the production of the latest drugs containing human cells in the Russian Federation. In addition, the Ministry of Health of the Russian Federation signed Order No. 512n of August 8, 2018 "On approval of the rules of good practice for working with biomedical cell products". Until now, the legislation is at the stage of formation and not a single registered BCP has been applied.