Dissemination of Regenerative Medicine - A comparison of the regulatory systems between Japan and Korea -

Although Japan has surpassed Korea in terms of R&D activities in the area of regenerative medicine, Korea has been more successful in its commercialization. As one of the key reasons for this, the 'posture' of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan is often criticized. Rather than dwelling on the abstract, this paper chooses to focus on the set up and operation of actual systems that take into consideration the promotion of regenerative medicine in Japan. Analysis and case studies of the regulatory systems in Japan and Korea show a clear difference between the two countries, although their systems are basically the same. There are two pathways for applying unapproved medicine in clinical research, including regenerative medicine, to human subjects in Japan, whereas there is only one pathway in Korea. The Korean Food & Drug Administration (KFDA) is the only authority through which approval can be gained in Korea. In comparison, Japan has one additional pathway besides approval through the PMDA if the clinical research is conducted within the framework of the Doctor’s Affairs Law.

We assume that the coexistence of the two pathways in Japan causes inefficiency in promoting the industrialization of regenerative medicine products. Therefore, it is advisable to combine the two pathways into one under PMDA authority, in order to disseminate regenerative medicine in Japan.

12-E-004 is the English version of an excerpt from this paper with some additional information and changes.