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Cell and gene therapy approvals in Japan and the need for international harmonization

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Data availability

The product approval information shown in this paper is available from the websites of the regulatory authorities (https://www.pmda.go.jp/english/search_index.html, https://www.ema.europa.eu/en/medicines, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products).

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Acknowledgements

We would like to thank Saki Yokoshiki for help in compiling product lists.

Author information

Authors and Affiliations

  1. Hokkaido University Hospital, Clinical Research and Medical Innovation Center, Sapporo, Japan

    Teruyo Arato

  2. Hokkaido University Graduate School of Medicine, Department of Regulatory Science, Sapporo, Japan

    Teruyo Arato

  3. Teikyo Heisei University, Faculty of Pharmaceutical Sciences, Tokyo, Japan

    Kaori Nomura

  4. Fukushima Medical University, Advanced Clinical Research Center, Fukushima, Japan

    Kaori Nomura

Authors
  1. Teruyo Arato
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  2. Kaori Nomura
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Contributions

Both authors contributed equally to conception and writing of the paper.

Corresponding author

Correspondence to Teruyo Arato.

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The authors declare no competing interests.

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Nature Biotechnology thanks Megan Munsie and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

Supplementary information

Supplementary Information

Supplementary Tables 1 and 2

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Arato, T., Nomura, K. Cell and gene therapy approvals in Japan and the need for international harmonization. Nat Biotechnol 42, 13–17 (2024). https://doi.org/10.1038/s41587-023-02053-7

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  • DOI: https://doi.org/10.1038/s41587-023-02053-7

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