Issues in the Introduction of the Advanced Regenerative Medicine Act

KimHyeonCheol,; Yoon, Erei

doi:10.34267/cbstl.2019.10.1.39

Cited by 1 publication

(1 citation statement)

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“…The ARMBA stipulated in August 2019 would be enforced from August 2020. The background of the stipulation is the recognition that while the advanced regenerative medicine has a huge potential to cure the incurable patients with the conventional treatments, but it is hard to approve the efficacy and safety of the advanced regenerative medicine (ARM) by the current regulatory framework used for the chemical drugs in the form of low molecule 16 . In addition, the various considerations necessary for the approval and control of the ARMs are not well covered by the current regulatory system such as the Medical Act and the PAA.…”

Section: The Armba and Xenotransplantationmentioning

confidence: 99%

Regulatory aspects of xenotransplantation in Korea

Kwon

Park

Lee

2020

Xenotransplantation

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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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Section: The Armba and Xenotransplantationmentioning

confidence: 99%