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

David Cyranoski; Douglas Sipp; Shreyashee Mallik; John E J Rasko

doi:10.1016/j.stem.2023.06.005

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

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

Authors

David Cyranoski¹, Douglas Sipp², Shreyashee Mallik³, John E J Rasko⁴

Affiliations

¹ Institute for the Advanced Study of Human Biology (ASHBi), Kyoto 606-8303, Japan. Electronic address: cyranoski.david.5n@kyoto-u.ac.jp.
² RIKEN Center for Biosystems Dynamics Research, Kobe 650-0047, Japan.
³ Gene and Stem Cell Therapy Program, Centenary Institute, University of Sydney, Sydney, NSW 2050, Australia.
⁴ Gene and Stem Cell Therapy Program, Centenary Institute, University of Sydney, Sydney, NSW 2050, Australia; Faculty of Medicine & Health, University of Sydney, Sydney, NSW 2050, Australia; Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital, SLHD, Sydney, NSW 2050, Australia. Electronic address: j.rasko@centenary.usyd.edu.org.

PMID: 37419104
DOI: 10.1016/j.stem.2023.06.005

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.

MeSH terms

Japan
Regenerative Medicine*