Realistic Prospects of Xenotransplantation in Japan: Specific Regulations for Clinical Application

Xenotransplantation has emerged as a potential solution to the critical shortage of donor organs, with recent breakthroughs demonstrating transplantation of genetically modified porcine organs into humans. In Japan, the Ministry of Health, Labour and Welfare has advanced the regulatory review framework to accelerate research and enable the nation's first clinical xenotransplantation. Unlike conventional pharmaceutical pathways, the Act on the Safety of Regenerative Medicine provides a distinctive framework that allows xenotransplantation to be delivered as a medical procedure rather than as a medicinal product. Under this law, a multi-step review process and adherence to specific guidelines, this framework may facilitate early-phase clinical research while safeguarding public health, offering an alternative model to regulatory systems in the other countries.