Review of regulatory documents governing the development and use of gene therapy

Gene therapy is one of the most promising areas of modern medicine and requires the development of robust regulatory mechanisms due to the potential irreversibility of interventions and potential long-term risks. The aim of the study was a comparative analysis of international and national regulations governing the development, clinical use, and post-marketing monitoring of gene therapy drugs. A systemic analysis of regulations from the European Union (EU), the United States, the United Kingdom, Japan, China, and the Russian Federation was conducted. It was found that in all legal systems examined, gene therapy is permitted exclusively for therapeutic purposes and is limited to interventions in somatic cells, while heritable genetic changes are prohibited or significantly limited. Regulatory models in the EU and the United States provide for accelerated registration procedures with mandatory long-term monitoring and the implementation of risk management plans. In the Russian Federation, gene therapy is regulated within the framework of pharmaceutical legislation, without classifying it as a separate category. These results demonstrate the need for further harmonization of international approaches to gene therapy regulation.