Regulatory aspects of xenotransplantation in Korea

Ivo Kwon, Chung Gyu Park, Seung Hwan Lee

Research output: Contribution to journalReview articlepeer-review

5 Scopus citations

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.

Original languageEnglish
Article numbere12602
JournalXenotransplantation
Volume27
Issue number3
DOIs
StatePublished - 1 May 2020

Keywords

  • Korean regulation
  • clinical trial
  • xenotransplantation

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