Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 May 15:1:80-83.
doi: 10.1016/j.reth.2015.04.001. eCollection 2015 Jun.

Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan

Kiyoshi Okada  1   2 , Kazuhisa Koike  3 , Yoshiki Sawa  2   4
Affiliations

Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan

Kiyoshi Okada et al. Regen Ther. .

Abstract

The Japanese regulatory framework for pharmaceuticals and medical devices has recently been reexamined and the revised Pharmaceutical Affairs Law, which has been renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, was developed in 2013 and implemented in November 2014. In the revised Act, regenerative medical products are newly categorized and independent from conventional pharmaceuticals and medical devices. This enables these products to be reviewed more appropriately and allows for conditional/time-limited marketing authorization. Following the implementation of the new Act, the Good, Gene Cell and Tissue Manufacturing Practice was established to address the different requirements and concepts for appropriate research and development of regenerative medical products. Based on these changes to the regulatory framework for regenerative medical products in Japan, this article aims to examine how this framework could be utilized as an appropriate system to develop innovative regenerative medicine.

Keywords: GCTP, Good, Gene, Cellular and Tissue-based Products Manufacturing Practice; MHLW, Ministry of Health, Labour and Welfare; PMD Act, Pharmaceuticals, Medical Devices and Other Therapeutic Products Act; PMDA, Pharmaceuticals and Medical Devices Agency; RMP Act, Regenerative Medicine Promoting Act; Regenerative medical products; Regenerative medicine; Regulation.

PubMed Disclaimer

References

    1. Hara A., Sato D., Sahara Y. New governmental regulatory system for stem cell-based therapies in Japan. Ther Innov Regul Sci. 2014;48(6):681–688. - PubMed
    1. Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act. 2013. http://www.mhlw.go.jp/topics/bukyoku/soumu/houritu/dl/183-55.pdf [in Japanese]. Law No. 84. [cited; available from:
    1. Cyranoski D. Japan to offer fast-track approval path for stem cell therapies. Nat Med. 2013;19(5):510. - PubMed
    1. Okada K. A new national framework for clinical trials and evaluation of innovative medical care technologies using living cell transplantation in Japan. J Transplant Technol Res. 2014;4(2):e137.
    1. Regenerative medicine promotion act. 2013 May 10. http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%8d%c4%90%... [in Japanese]. Law No.13. [cited; available from:

LinkOut - more resources