Biomedical Cell Products or High-Tech Drugs?

Abstract

Marketing authorisation is a prerequisite for the use of drugs in medical practice in the Russian Federation. The marketing authorisation procedure is applicable to ordinary medicinal products. As for advanced therapy medicinal products containing viable human cells — there are currently two authorisations pathways: athorisation of biomedical cell products (BCPs) at the national level according to the Federal Law No. 180-FZ «On biomedical cell products», and authorisation of high-technology drugs (HTDs) in the Eurasian Economic Union (EEU). The production, pre-clinical and clinical studies, expert evaluation and marketing authorisation procedures are regulated by different legal acts and differ significantly. The aim of the study was to perform comparative analysis of concepts, terms, production process requirements, designs of pre-clinical and clinical studies, and the marketing authorisation procedures for BCPs as defined in the Russian and EEU legislation. It should be noted that both the Federal Law No. 180-FZ and the EEU legislative framework are not currently used due to the lack of such drugs (somatic cell-based BCPs or HTDs). Therefore, at present, the choice of the procedure of obtaining marketing authorisation for drugs containing viable human cells has to be made by the manufacturer, until the Russian and EEU legal frameworks become harmonised.