Elaboration of regulatory approaches to managing the risk of the use of biomedical cell products in the Russian Federation

Introduction. In recent years, the Russian Federation has created a regulatory framework for putting biomedical cell products (BMCP) into civil circulation. The BMCP market in our country is just beginning to develop, while this market in the EU and the USA is actively providing new opportunities for healthcare and patients. Due to the complexity of the composition, to the individual use, and high cost of these medicines, developers and regulatory authorities face new questions about the management of risks associated with the use of BMCP. Objective: to analyze risk-oriented approaches by foreign regulatory authorities having their practical experience in examining and regulating the circulation of BMCP analogues on the market in order to elaborate national approaches to managing the risk of BMCP usage. Material and methods. The investigation was based on the normative documents regulating the circulation of BMCP analogues in the USA and the EU and the guidelines prepared by regulatory authorities. Logical methods of system analysis and modeling were used in the investigation. Results. The investigators studied the currently developed requirements for risk management at all stages of the BMCP life cycle, starting from the early development stage. The information about the introduced approaches to BMCP risk management is given. The analysis of various regulatory approaches to assessing the risks during BMCP circulation made it possible to propose areas for improving the regulation of BMCP circulation. It showed the necessity of creating separate guidelines for developers of BMCP at all stages of their life cycle, by taking into account the specific risks for each type of BMCP. Conclusion. It is necessary to create and maintain a patient and product traceability system with the necessary detail to ensure quality and establish causal relationships between drugs and incoming signals, as well as between a drug and a patient at all stages of the BMCP life cycle from production to destruction.

biomedical cell product (BMCP), medicinal products based on viable human cells, gene therapy, somatic cell therapy, tissue-engineering product, risk-oriented approach, risk management plan