Regulatory Landscape of Regenerative Medicine in Japan

Last year, Japan exercised two new acts, the Act on the Safety of Regenerative Medicine (RM Act) and Pharmaceuticals and Medical Devices Act (PMD Act). These acts have significantly changed the conditions for clinical application of regenerative medicine. The RM Act covers clinical research and medical practice using processed cells. It specifies the procedures required for clearance to administer said processed cells to humans. The RM Act also introduces a licensing scheme for cell processing centers outside medical institutions. The PMD Act, on the other hand, introduces a specific regulatory framework for regenerative medicine products. Under the PMD Act, conditional and time-limited marketing approval will be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety. Combined with other measures to facilitate R&D, it is expected that these changes will accelerate the clinical application and commercialization of innovative regenerative medicine therapy.