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.