Overview of the clinical application of regenerative medicine products in Japan.
OBJECTIVE
To identify barriers to the clinical application of regenerative medicine products (RMPs) in Japan.


METHODS
Current Japanese regulatory systems and guidelines were compared with those of the United States (US) and the European Union (EU). A questionnaire was administered to representatives from 23 Japanese companies and 10 research institutes, and an in-person semi-structured interview was conducted with representatives from 10 companies that develop RMP.


RESULTS
We found that Japan, the US and the EU have similar pre-clinical safety guideline frameworks relating to RMP. However, differences exist between these countries with respect to their review and approval systems and the implementation of guidelines, and these represent major barriers to the clinical application of RMP in Japan. Most companies studied are facing regulatory hurdles such as stringent review processes and regulatory guidelines that do not provide detailed practical examples of the pre-clinical quality and safety data required.


CONCLUSIONS
These results suggest that effective regulatory infrastructure including regulatory systems, guidelines, and communication channels between product developers and regulatory bodies are essential for the prompt clinical application of RMP in Japan.
Tsubouchi
Mina
M
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Matsui
Shigeyuki
S
Banno
Yoshiro
Y
Kurokawa
Kiyoshi
K
Kawakami
Koji
K
D002985:Clinical Protocols; D005062:European Union; D006801:Humans; D007407:Interviews as Topic; D007564:Japan; D017410:Practice Guidelines as Topic; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D011795:Surveys and Questionnaires; D014481:United States