Hosoya Satoshi, Ukon Yuichiro, Morita Kazuki, Minegishi Eisuke, Sugihara Jun, Hasegawa Manabu
Research and Development Policy Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
Regen Ther. 2025 Jun 18;30:217-223. doi: 10.1016/j.reth.2025.06.006. eCollection 2025 Dec.
The amended Act on the Safety of Regenerative Medicine (RM Act) in Japan expands its scope to include gene therapy and related technologies, classifying them into Class I, the highest-risk category. Furthermore, the amended RM Act introduces additional requirements, such as proper conflict of interest management and a specific evaluation of the scientific validity of provision plans by Certified Committees for Regenerative Medicine to ensure a fair review. These detailed regulatory amendments will be stipulated in the cabinet order and the ministerial ordinance, which are subordinate to the law. The amendments are set to take effect on May 31, 2025. This article provides a detailed overview of the amendments introduced under the RM Act.
日本修订后的《再生医学安全法》（《再生医学法》）扩大了范围，将基因治疗及相关技术纳入其中，并将其归类为最高风险的第一类。此外，修订后的《再生医学法》引入了额外要求，如适当的利益冲突管理，以及由再生医学认证委员会对提供计划的科学有效性进行具体评估，以确保公平审查。这些详细的监管修订将在从属于该法律的内阁令和部令中加以规定。修订案将于2025年5月31日生效。本文详细概述了《再生医学法》所引入的修订内容。
