Reflection on the enactment and impact of safety laws for regenerative medicine in Japan
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 r...
| Главные авторы: | , , |
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| Формат: | Journal article |
| Язык: | English |
| Опубликовано: |
Cell Press
2021
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| _version_ | 1826258490801258496 |
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| author | Takashima, K Morrison, M Minari, J |
| author_facet | Takashima, K Morrison, M Minari, J |
| author_sort | Takashima, K |
| collection | OXFORD |
| description | 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. |
| first_indexed | 2024-03-06T18:34:47Z |
| format | Journal article |
| id | oxford-uuid:0adaaae4-9a28-4ea1-bd23-ce35ab58ed48 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T18:34:47Z |
| publishDate | 2021 |
| publisher | Cell Press |
| record_format | dspace |
| spelling | oxford-uuid:0adaaae4-9a28-4ea1-bd23-ce35ab58ed482022-03-26T09:26:17ZReflection on the enactment and impact of safety laws for regenerative medicine in JapanJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:0adaaae4-9a28-4ea1-bd23-ce35ab58ed48EnglishSymplectic ElementsCell Press2021Takashima, KMorrison, MMinari, JJapan'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. |
| spellingShingle | Takashima, K Morrison, M Minari, J Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title | Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title_full | Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title_fullStr | Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title_full_unstemmed | Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title_short | Reflection on the enactment and impact of safety laws for regenerative medicine in Japan |
| title_sort | reflection on the enactment and impact of safety laws for regenerative medicine in japan |
| work_keys_str_mv | AT takashimak reflectionontheenactmentandimpactofsafetylawsforregenerativemedicineinjapan AT morrisonm reflectionontheenactmentandimpactofsafetylawsforregenerativemedicineinjapan AT minarij reflectionontheenactmentandimpactofsafetylawsforregenerativemedicineinjapan |