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. 2024 Dec 10;19(12):1648-1650.
doi: 10.1016/j.stemcr.2024.10.006. Epub 2024 Nov 14.

Amendments to ASRM: Can we move away from a "Therapeutic Haven"?

Tsunakuni Ikka  1 , Taichi Hatta  2 , Misao Fujita  3
Affiliations

Amendments to ASRM: Can we move away from a "Therapeutic Haven"?

Tsunakuni Ikka et al. Stem Cell Reports. .

Abstract

The key amendment to the Act on the Safety of Regenerative Medicine in June 2024 is regarding on-site inspections and the criteria for disqualifying the Certified Special Committees for Regenerative Medicine and Certified Committees for Regenerative Medicine. Appropriate regulations are needed after the legal amendment to stop the widespread use of unproven interventions and move away from the concept of a "Therapeutic Haven."

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Conflict of interest statement

Declaration of interests We conducted the studies for improving the quality of the CSCRMs/CCRMs commissioned by the MHLW in FY 2019–2020.

References

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    1. Ikka T., Hatta T., Saito Y., Fujita M. Does the Act on the Safety of Regenerative Medicine in Japan ensure “safety”?: Implications of low adverse event reporting. Stem Cell Rep. 2023;18:2297–2299. doi: 10.1016/j.stemcr.2023.10.012. - DOI - PMC - PubMed
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