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Evolving Japanese regulations on companion diagnostics

Nature Biotechnology volume 34, pages 141–144 (2016)Cite this article

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To the Editor:

Precision medicine involves the identification of a group of patients on the basis of a biomarker measured via a companion diagnostic who are then treated with a therapeutic targeted against that biomarker. The Japanese regulatory agency responsible for overseeing the regulatory oversight of companion diagnostics is the Pharmaceuticals and Medical Devices Agency (PMDA; Tokyo), which works with the Ministry of Health, Labor and Welfare (MHLW; Tokyo). In September 2014, the PMDA held a workshop on companion diagnostics that brought together >400 participants from academia, industry and regulatory agencies. The workshop identified the evaluation of concordance among different diagnostics targeting the same marker and the assessment of multiplex diagnostics as two key outstanding challenges. In the following correspondence, we briefly introduce PMDA's and MHLW's activities with regard to companion diagnostics, compare key differences among Japanese, US and European Union (EU; Brussels) regulations, and conclude by describing challenges relating to companion diagnostics discussed at the workshop.

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References

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Acknowledgements

We thank T. Yamori, director of the center for product evaluation of the PMDA, and the following other present and former members of the companion diagnostics working group of the PMDA: N. Sakamoto, A. Enokida, Y. Ohgushi, A. Ezaki, N. Komiyama, H. Komiya, M. Kanematsu, A. Nitta, N. Fuse, A. Hachisuka, Y. Kobayashi, Y. Onodera, A. Kobayashi, Y. Otsubo, N. Honma, S. Yagi, M. Gushima, Y. Sakamoto, Y. Asahina, K. Kato, S. Tokuhiro, H. Nakamura, Y. Yamagishi, A. Sugawara, Y. Ohta, H. Sekizaki, Y. Satake, A. Ishiguro, T. Makino, T. Nonaka, Y. Uyama, S. Miyazaki, M. Shibatsuji, D. Sato, N. Kono, T. Sato, T. Tawaragi, H. Yamamoto and K. Shigeto.

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Authors and Affiliations

  1. Companion Diagnostics Working Group, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

    Sumimasa Nagai, Masaaki Urata, Hiroyuki Sato, Motoki Mikami, Wataru Kuga, Reiko Yanagihara, Daisei Miyamoto, Yuka Suzuki & Mayumi Shikano

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  1. Sumimasa Nagai
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  2. Masaaki Urata
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  3. Hiroyuki Sato
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  4. Motoki Mikami
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  7. Daisei Miyamoto
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  8. Yuka Suzuki
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  9. Mayumi Shikano
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Correspondence to Sumimasa Nagai.

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Nagai, S., Urata, M., Sato, H. et al. Evolving Japanese regulations on companion diagnostics. Nat Biotechnol 34, 141–144 (2016). https://doi.org/10.1038/nbt.3478

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