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Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies

Azuma, Kentaro, Yamanaka, Shinya·2016·Regenerative Therapy
DOI 10.1016/j.reth.2016.01.009PMC PMC6581825
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  • In September 2014, the Japanese Diet enacted laws and amendments intended to improve and simplify the regulation of regenerative medicine in Japan.

    “In September 2014, the Japanese Diet, or legislature, enacted a set of laws and amendments intended to improve and simplify the regulation of regenerative medicine in Japan”

    From Brief summary of the regulatory frameworks of regenerative medicine therapies (2025) · cites this paper as Azuma and Yamanaka, 2016

    The sections on conditional approval and alternative clinical research describe revisions to Japan’s regenerative-medicine regulations, including a new product category and changes to the rules for clinical research. They say the revised PMD Act became effective in November 2014 and the RM Act applied from November 2014; they do not establish that the Japanese Diet enacted the laws in September 2014. (LLM, conf=0.84)

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Authors
Azuma, K., & Yamanaka, S.
Venue
Regenerative Therapy
Publisher
Elsevier BV
Published
2016-06
Volume
4
Pages
36-47
ISSN
2352-3204
DOI
10.1016/j.reth.2016.01.009
PMC
PMC6581825
Cited by
59
References
7
Language
en
Licence
Funders
Japan Agency for Medical Research and Development (AMED), Research Center Network for Realization of Regenerative Medicine

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