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. 2023 Jul 6;30(7):913-916.
doi: 10.1016/j.stem.2023.06.005.

Too little, too soon: Japan's experiment in regenerative medicine deregulation

David Cyranoski  1 , Douglas Sipp  2 , Shreyashee Mallik  3 , John E J Rasko  4
Affiliations
Free article

Too little, too soon: Japan's experiment in regenerative medicine deregulation

David Cyranoski et al. Cell Stem Cell. .
Free article

Abstract

In 2013, Japan established a conditional approval pathway for cell and gene therapies. Our analysis of the four products approved via this pathway identifies evidence suggesting shortcomings in safety and efficacy data submitted by the sponsors and raises concerns about whether this pathway is delivering on its promise.

Keywords: Japan; biomedical regulation; cell therapy; conditional approval; ethics; expedited pathways; gene therapy; health policy; post-market studies; regenerative medicine.

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Conflict of interest statement

Declaration of interests J.E.J.R. has served as an investigator in clinical trials sponsored by Cynata Therapeutics, Australia, developing allogeneic cell therapies and other sponsored cell and gene therapy trials over two decades.

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