Dissemination of Regenerative Medicine in Japan: Promoting commercialization under the regulatory system

Though Japan has surpassed South Korea in terms of research and development (R&D) in the area of regenerative medicine, South Korea has been more successful at commercialization. This paper focuses on the setup and operation of actual systems that consider the promotion of regenerative medicine in Japan. Analysis of the regulatory systems in Japan and South Korea shows a clear difference between the two countries, although their systems are basically the same. There are two pathways for applying unapproved drugs in clinical research, including regenerative medicine, to human subjects in Japan, whereas there is only one pathway in South Korea, where the Korea Food and Drug Administration (KFDA) is the only authority through which approval can be obtained. Japan has an additional pathway besides approval through the Pharmaceuticals and Medical Devices Agency (PMDA), if the clinical research is conducted within the framework of the Medical Practitioners Law.

The authors assume that the coexistence of the two pathways in Japan creates inefficiencies in commercializing regenerative medicine products (RMPs). Therefore, to disseminate regenerative medicine in Japan, the authors recommend combining the two pathways under PMDA authority.

This paper is the English version of an excerpt from the Japanese Discussion Paper (10-J-039) with some additional information and changes.