Impact and challenges of enactment for advanced regenerative medicine in South Korea
- 주제(키워드) regenerative medicine , enactment , biological products , safety , South Korea
- 주제(기타) Biotechnology & Applied Microbiology; Multidisciplinary Sciences
- 설명문(일반) [Kim, Dong-Sook] Hlth Insurance Review & Assessment Serv, Dept Res, Wonju, South Korea; [Bae, SeungJin] Ewha Womans Univ, Coll Pharm, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 gold, Green Published
- 발행기관 FRONTIERS MEDIA SA
- 발행년도 2022
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000203066
- 본문언어 영어
- Published As https://doi.org/10.3389/fbioe.2022.972865
- PubMed https://pubmed.ncbi.nlm.nih.gov/36312539
초록/요약
The Korean government has enacted the Act on Advanced Regenerative Medicine and Advanced Biological products (ARMAB) in August 2019, and it has been implemented in 2020. We reviewed the changes made by ARMAB compared to the existing Pharmaceutical Affairs Act and discussed future challenges to accelerate regenerative medicine while ensuring safety and efficacy. This act and regulations focused on the key elements of act as follows: the definition of advanced regenerative medicine (RM), the licensing of related facilities, safety management such as long-term follow-up, clinical research review committee, and establishment of a roadmap. Our study shows that Korea has achieved the second highest number of first approvals for regenerative medicine indications worldwide through expedited approvals encouraging innovation, while maintaining patient safety by mandating long-term follow-up. Additionally, the establishment of an interactive system for retrieval of patients' data and reporting of safety information by manufacturers electronically demonstrates Korea's commitment to innovation for Advanced RM and patient safety.
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