Brief summary of the regulatory frameworks of regenerative medicine therapies
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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1486812/full |
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| author | Jinah Yoon Sukhyang Lee Sukhyang Lee Min Jung Kim Min Jung Kim Jung-Hyun Kim Jung-Hyun Kim |
| author_facet | Jinah Yoon Sukhyang Lee Sukhyang Lee Min Jung Kim Min Jung Kim Jung-Hyun Kim Jung-Hyun Kim |
| author_sort | Jinah Yoon |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b6155b4fe9c6408b824db1b03bcc1453 |
| institution | Kabale University |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-b6155b4fe9c6408b824db1b03bcc14532025-01-22T07:11:31ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-01-011510.3389/fphar.2024.14868121486812Brief summary of the regulatory frameworks of regenerative medicine therapiesJinah Yoon0Sukhyang Lee1Sukhyang Lee2Min Jung Kim3Min Jung Kim4Jung-Hyun Kim5Jung-Hyun Kim6Department of Law, Hanyang Cyber University, Seoul, Republic of KoreaCollege of Pharmacy, Ajou University, Suwon, Republic of KoreaDepartment of Biohealth Regulatory Science, Graduate School of Ajou University, Suwon, Republic of KoreaCollege of Pharmacy, Ajou University, Suwon, Republic of KoreaDepartment of Biohealth Regulatory Science, Graduate School of Ajou University, Suwon, Republic of KoreaCollege of Pharmacy, Ajou University, Suwon, Republic of KoreaDepartment of Biohealth Regulatory Science, Graduate School of Ajou University, Suwon, Republic of KoreaThe 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.https://www.frontiersin.org/articles/10.3389/fphar.2024.1486812/fullregenerative medicinelegislationregulatory authoritiescell therapygene therapy |
| spellingShingle | Jinah Yoon Sukhyang Lee Sukhyang Lee Min Jung Kim Min Jung Kim Jung-Hyun Kim Jung-Hyun Kim Brief summary of the regulatory frameworks of regenerative medicine therapies Frontiers in Pharmacology regenerative medicine legislation regulatory authorities cell therapy gene therapy |
| title | Brief summary of the regulatory frameworks of regenerative medicine therapies |
| title_full | Brief summary of the regulatory frameworks of regenerative medicine therapies |
| title_fullStr | Brief summary of the regulatory frameworks of regenerative medicine therapies |
| title_full_unstemmed | Brief summary of the regulatory frameworks of regenerative medicine therapies |
| title_short | Brief summary of the regulatory frameworks of regenerative medicine therapies |
| title_sort | brief summary of the regulatory frameworks of regenerative medicine therapies |
| topic | regenerative medicine legislation regulatory authorities cell therapy gene therapy |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2024.1486812/full |
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