Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan
Abstract
(Stem Cell Reports 18, 613–617; March 14, 2023) The authors have changed all references to “Whitelist” in the supplemental information to the term “DOAJ or Web of Science.” The reason for the change was to use a more socially fair and neutral term that does not contain discriminatory meanings or misinterpretations. Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in JapanIkka et al.Stem Cell ReportsFebruary 23, 2023In BriefWe outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies. Full-Text PDF Open Access
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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 Ikka et al., 2023
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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
- Ikka, T., Fujita, M., Hatta, T., Isobe, T., Konomi, K., Onishi, T., Sanada, S., Sato, Y., Tashiro, S., & Tobita, M.
- Venue
- Stem Cell Reports
- Publisher
- Elsevier BV
- Published
- 2023-05
- Volume
- 18
- Issue
- 5
- Pages
- 1247
- ISSN
- 2213-6711
- Cited by
- 3
- References
- 0
- Language
- en
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