Detailed revisions to the subordinate regulation following the amendment of the Act on the Safety of Regenerative Medicine in Japan.

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.