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. 2023 Dec 12;18(12):2297-2299.
doi: 10.1016/j.stemcr.2023.10.012. Epub 2023 Nov 16.

Does the Act on the Safety of Regenerative Medicine in Japan ensure "safety"?: Implications of low adverse event reporting

Tsunakuni Ikka  1 , Taichi Hatta  2 , Yoko Saito  3 , Misao Fujita  4
Affiliations

Does the Act on the Safety of Regenerative Medicine in Japan ensure "safety"?: Implications of low adverse event reporting

Tsunakuni Ikka et al. Stem Cell Reports. .

Abstract

Public document analysis reveals that the adverse events reported for therapeutic administration under the Act on the Safety of Regenerative Medicine (ASRM) in Japan are substantially fewer than those under the Pharmaceuticals and Medical Devices Act. This study highlights the flawed reporting mechanisms and unmet legislative intentions of the ASRM.

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Conflict of interest statement

Declaration of interests The authors declare no competing interests.

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