Journal article : Review
Reflection on the enactment and impact of safety laws for regenerative medicine in Japan
- Abstract:
- Japan's Act on the Safety of Regenerative Medicine (ASRM) created an innovative regulatory framework intended to safely promote the clinical development of stem cell-based interventions (SCBIs) while subjecting commercialized unproven SCBIs to greater scrutiny and accountability. This article reviews ASRM’s origins, explains its unprecedented scope, and assesses how it envisions the regulation of SCBIs. This analysis is used to highlight three key insights that are pertinent to the current revision of the ASRM: clarifying how the concept of safety should be defined and assessed in research and clinical care settings; revisiting risk criteria for review of SCBIs; and taking stronger measures to support the transition from unproven interventions to evidence-based therapies. Finally, the article reflects on lessons drawn from Japanese experiences in dealing with unproven SCBIs for international endeavors to regulate SCBIs.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, 760.6KB, Terms of use)
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- Publisher copy:
- 10.1016/j.stemcr.2021.04.017
Authors
- Publisher:
- Cell Press
- Journal:
- Stem Cell Reports More from this journal
- Volume:
- 16
- Issue:
- 6
- Pages:
- 1425-1434
- Publication date:
- 2021-05-20
- Acceptance date:
- 2021-04-23
- DOI:
- EISSN:
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2213-6711
- Language:
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English
- Keywords:
- Subtype:
-
Review
- Pubs id:
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1178071
- Local pid:
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pubs:1178071
- Deposit date:
-
2021-05-25
Terms of use
- Copyright holder:
- Takashima et al.
- Copyright date:
- 2021
- Rights statement:
- © 2021 The Authors. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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