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.
The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This research was supported by grants from the National Research Foundation of Korea (RS-2024-00441316) funded by the Ministry of Science. This research was supported by a grant (21153MFDS602) from the Ministry of Food and Drug Safety. This work was supported by the Ajou University research fund.
