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Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA’s perspective

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Abstract

Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pluripotent stem cell for personalized tissue or organ, and xenotransplantation. To bridge the gap between scientific innovation and regulatory product review, Pharmaceuticals and Medical Devices Agency of Japan (PMDA) started the science board to discuss about the new scientific topics regarding medical products including medical device and regenerative products with external experts since 2012. Topics which PMDA raised for science board included cellular and tissue-based products from iPS cells, artificial intelligence and genome editing technology. In addition, PMDA started the horizon scanning to identify a new cutting edge technology which could potentially lead to innovative health technology or product, which has a strong impact on clinical medicine. Although the effectiveness and safety of the medical products must be reasonably assured before clinical use, PMDA introduced Sakigake review assignment (a review partner of device development) and conditional approval system to balance between pre-market and post-market evaluation.

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Funding

This study was supported by internal funding from the Pharmaceuticals and Medical Devices Agency, Tokyo Japan.

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Authors and Affiliations

  1. Office of Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

    Nobuhiro Handa & Shuichi Mochizuki

  2. Office of Regenerative Medicine, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

    Yasuhiro Fujiwara

  3. Regulatory Science Center, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

    Masafumi Shimokawa, Rika Wakao & Hiroyuki Arai

  4. Medical Device Unit, Pharmaceuticals and Medical Devices Agency, 3-3-2, Shin-Kasumigaseki Building 11F, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Nobuhiro Handa

Authors
  1. Nobuhiro Handa
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  2. Shuichi Mochizuki
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  3. Yasuhiro Fujiwara
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  4. Masafumi Shimokawa
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  5. Rika Wakao
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  6. Hiroyuki Arai
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Corresponding author

Correspondence to Nobuhiro Handa.

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Conflict of interest

The views of this article are personal opinions of the authors and do not necessarily reflect the official one from the PMDA. All the authors have nothing to disclose regarding any competing conflict of interest which is related to the article.

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This article was read at the 8th annual meeting of the International Federations of Artificial Organs.

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Handa, N., Mochizuki, S., Fujiwara, Y. et al. Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA’s perspective. J Artif Organs 23, 203–206 (2020). https://doi.org/10.1007/s10047-020-01161-4

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  • DOI: https://doi.org/10.1007/s10047-020-01161-4

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