New Governmental Regulatory System for Stem Cell-Based Therapies in Japan

Therapeutic Innovation & Regulatory Science
Akinori HaraYasuyuki Sahara

Abstract

Regenerative medicine using stem cells is expected to provide tools for the replacement or repair of damaged tissues, opening up the possibility of treating many diseases that cannot otherwise be effectively treated. To promote the development of and access to regenerative medicine, it is important to take a balance of expedited provision of innovative therapies and appropriate steps to ensure safety and efficacy. While most developed countries have various regulatory frameworks for clinical trials and medical treatments involving stem cells, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law have recently been simultaneously passed by the Japanese Diet. According to the former act, these medical technologies are categorized into 3 classes depending on their anticipated potential risk to human health, and the specific procedures falling into each class are determined. In addition, the act enables medical institutions to commission cell processing by business facilities outside the institution (even foreign facilities) that fulfill the requirements set out by the Ministry of Health, Labour and Welfare, with the aim to promote collaboration between academia and industry from an early stage. ...Continue Reading

References

Oct 20, 2006·The New England Journal of Medicine·Dina Gould Halme, David A Kessler
Nov 26, 2010·Nature·David Cyranoski
Dec 3, 2010·The New England Journal of Medicine·Margaret A Hamburg
Mar 1, 2013·Nature·David Cyranoski
Oct 22, 2013·JAMA : the Journal of the American Medical Association·UNKNOWN World Medical Association

❮ Previous
Next ❯

Citations

Feb 7, 2018·Hepatology Communications·Giuseppe MazzaMassimo Pinzani
Jun 24, 2014·Nature·Paolo Bianco, Douglas Sipp
Jul 20, 2014·Stem Cells Translational Medicine·Ellen G FeigalNatalie Mount
Sep 13, 2016·International Journal of Molecular Sciences·Salazar JonesXiaofeng Jia
Nov 1, 2016·Therapeutic Innovation & Regulatory Science·Christopher-Paul MilneGabrielle Simmons
Oct 21, 2015·Clinical Pharmacology and Therapeutics·Y Fujita, A Kawamoto
May 24, 2016·Stem Cells International·Kulraj Singh BhangraAhad A Rahim
Apr 3, 2019·Journal of Tissue Engineering and Regenerative Medicine·Yoshiki Sawa
Sep 30, 2015·Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences·Natalie M MountJohan Hyllner
Dec 19, 2015·Regenerative Medicine·Michelle G J L HabetsAnnelien L Bredenoord
May 8, 2018·Therapeutic Innovation & Regulatory Science·Makoto TanakaKatsura Tsukamoto
Mar 17, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Yasuko Inokuma
Jan 8, 2020·Tissue Engineering. Part B, Reviews·Caroline Veronique OberweisPatricia Gálvez-Martín
Mar 1, 2019·Acta Obstetricia Et Gynecologica Scandinavica·Suzanna QueckbörnerKristina Gemzell-Danielsson
Feb 29, 2020·Regenerative Therapy·Edward H NtegeYusuke Shimizu

❮ Previous
Next ❯

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.

Related Papers

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyūjo hōkoku = Bulletin of National Institute of Health Sciences
Yoji Sato
Advances in Experimental Medicine and Biology
Daisuke MaedaDaisaku Sato
Biologicals : Journal of the International Association of Biological Standardization
Tetsuya Kusakabe
© 2022 Meta ULC. All rights reserved