Amendment of the Act on the Safety of Regenerative Medicine: A new voyage of regenerative medicine in Japan and the dawn of a new era for young investigators

Abstract

Aiming to promote the safe and appropriate provision of regenerative medicine (RM) in Japan, the Japanese government implemented the Act on the Safety of Regenerative Medicine (RM Act) on November 25, 2014. A supplemental rule of the RM Act stipulated that its legal framework be reviewed 5 years after implementation assessing scientific progress and environmental change, and based on the review that amendments to the legal framework be considered. The review of the RM Act started in July 2019, and an act to partially amend the RM Act and the Clinical Trials Act (the Amendment Act) was promulgated on June 14, 2024. The Amendment Act added gene therapy and its related technologies to the scope of the RM Act, and on-site inspections and grounds for disqualification of Certified Committees for RM were established. In the present review, which is based on publicly available material, we summarize the flow of the discussions concerning the regulatory changes to the RM Act as well as other pertinent matters. In addition, in line with the scope of the special issue “Future of Regenerative Medicine Viewed by Young Scientists”, based on our experience as young investigators with the perspective of officers under this unique legal framework, we offer insights that RM research investigators, including international and experienced professional investigators, who will contribute to Japan's continued status as a world leader in RM, should consider in their RM research for in light of the recent amendment of the RM Act.