1. Reason for Amendment
To improve patient access to advanced regenerative medicine and strengthen safety management, the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" has been amended (Law No. 20331, promulgated on February 20, 2024, effective from February 21, 2025). This amendment stipulates matters delegated by the law and its enforcement decree, as well as necessary provisions for implementation, aiming to address and improve deficiencies in the current system.
2. Key Contents
a. Preparation and Submission of Advanced Regenerative Medicine Research Plans (Article 4)
- As the clinical research subject restriction has been removed due to the law amendment, details related to the setting of research subjects will be excluded from the research plan submission documents.
b. Receipt of Advanced Regenerative Medicine Research Plans (Article 5)
- Specific grounds for rejecting an application, such as providing false information or failing to submit additional materials after a request for supplementation, are clarified.
c. Review of Advanced Regenerative Medicine Research Plans (Article 7)
- The research plan will be reviewed through the evaluation of the expert committee and the decision of the review committee. If necessary, requests for supplementation or on-site inspections may be conducted.
d. Calculation of Review Period (Article 7-3)
- The period spent on supplementing the application form and attached documents will not be included in the review period calculation, and the processing period calculation method will follow the Civil Complaint Handling Act.
e. Data Submission During Clinical Research of Advanced Regenerative Medicine (Article 7-4)
- Researchers must submit reports on research subjects, adverse reactions, and measures taken according to the reporting schedule determined upon approval of the research plan.
- The final report must be submitted to the review committee within 20 days of the observation end date for the last research subject, and the results report, including safety and efficacy evaluation data, must be submitted within 90 days.
f. Changes to Advanced Regenerative Medicine Research Plans (Article 8)
- If a regenerative medicine institution wishes to change the research plan, the changes must be reported, and if the changes are significant, the review committee must review the changes again.
