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Regulatory aspects of xenotransplantation in Korea

Title
Regulatory aspects of xenotransplantation in Korea
Authors
Kwon, IvoPark, Chung-GyuLee, SeungHwan
Ewha Authors
권복규
SCOPUS Author ID
권복규scopus
Issue Date
2020
Journal Title
XENOTRANSPLANTATION
ISSN
0908-665XJCR Link

1399-3089JCR Link
Citation
XENOTRANSPLANTATION vol. 27, no. 3
Keywords
clinical trialKorean regulationxenotransplantation
Publisher
WILEY
Indexed
SCIE; SCOPUS WOS
Document Type
Review
Abstract
Background The xenotransplant clinical trial with human subjects seems to be technically feasible, however, it needs the strict regulatory framework from the domestic as well as the international level to make sure the safety of the human subject and the general public. Methods The authors reviewed and introduced the current regulations regarding the xenotransplant clinical trial in Korea focusing on the recently stipulated act (Advanced Regenerative Medicine and Biopharmacology Act, ARMBA) and the role of the related government agencies and health institutions. Results and Conclusion Korea is ready to conduct the xenotransplant clinical trial with human subjects in the current regulatory framework satisfying the requirements of the international guidance. The responsible governmental agencies would collaborate in control the xenotransplant clinical trial under the ARMBA and other related acts and guidance.
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DOI
10.1111/xen.12602
Appears in Collections:
의과대학 > 의학과 > Journal papers
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