Japan's challenges of translational regenerative medicine: act on the safety of regenerative medicine
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The ASRM applies to medical treatments that intend to use cell-processed products, and applicable clinical trials are reviewed by certified committees for RM or the Certified Special Committee for Regenerative Medicine accredited by MHLW.
“The ASRM applies to medical treatments that intend to use cell-processed products (Article 2).”
From Brief summary of the regulatory frameworks of regenerative medicine therapies (2025) · cites this paper as Tobita et al., 2016
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Research works printed but not linked: 5
- [1]Fukushima M. Clinical trials in Japan Nat Med 1 1995 12 13 7584938
- [2]Konomi K. Tobita M. Kimura K. Sato D. New Japanese initiatives on stem cell therapies Cell Stem Cell 16 2015 350 352 25842974
- [3]Hara A. Sato D. Sahara Y. New governmental regulatory system for stem cell-based therapies in Japan Ther Innov Regul Sci 48 2014 681 688 30227468
- [4]Cyranoski D. Japan to offer fast-track approval path for stem cell therapies Nat Med 19 2013 510 23652082
- [5]World Medical Association World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects JAMA 310 2013 2191 2194 24141714
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Brief summary of the regulatory frameworks of regenerative medicine therapies
Yoon, J., Lee, S., Kim, M. J., & Kim, J.-H. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1486812 · Cited by 38 · see citing works
- Authors
- Tobita, M., Konomi, K., Torashima, Y., Kimura, K., Taoka, M., & Kaminota, M.
- ORCID
- Kaminota, Masahiro
- Venue
- Regenerative Therapy
- Publisher
- Elsevier BV
- Published
- 2016-06
- Volume
- 4
- Pages
- 78-81
- ISSN
- 2352-3204
- PMC
- PMC6581824
- Cited by
- 59
- References
- 0
- Language
- en
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