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MINI REVIEW article

Front. Pharmacol.
Sec. Translational Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1486812

Brief summary of the regulatory frameworks of regenerative medicine therapies

Provisionally accepted
Jung-Hyun Kim Jung-Hyun Kim 1*Jinha Yoon Jinha Yoon 2Sukhyang Lee Sukhyang Lee 1
  • 1 Ajou University, Suweon, Republic of Korea
  • 2 Hanyang Cyber University, Seoul, Republic of Korea

The final, formatted version of the article will be published soon.

    The rapid advancements in regenerative medicine (RM), including cell therapies, gene therapies, tissue-engineered products, and combined RM advanced therapies, require the development of regulatory frameworks. The global landscape of regulatory frameworks presents diverse approaches to the oversight of these therapies, posing challenges in the global application of RM. This paper reviews the regulatory frameworks for RM across the United States, European Union, Japan, Canada, Australia, Taiwan, and South Korea and compares the unique features of the respective legislations.

    Keywords: Regenerative Medicine, legislation, Regulatory authorities, cell therapy, Gene Therapy

    Received: 27 Aug 2024; Accepted: 23 Dec 2024.

    Copyright: © 2024 Kim, Yoon and Lee. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Jung-Hyun Kim, Ajou University, Suweon, Republic of Korea

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.