a. Standards for Implementing Advanced Regenerative Medicine Treatments (Article 3 of the Draft)
- In addition to compliance with matters specified in the laws and regulations, the treatment must include the registration of treatment records through the safety management information system and cooperation with safety management organizations.
b. Preparation and Submission of Advanced Regenerative Medicine Treatment Plans (Article 4 of the Draft)
- The treatment plan must include the processing plan for human cells, facilities, equipment, personnel operation plans, and the final results of implementing the same purpose and content of the advanced regenerative medicine treatment, and must be submitted.
c. Receipt of Advanced Regenerative Medicine Treatment Plans (Article 5 of the Draft)
- The Secretariat of the Review Committee will review the submitted application and attached documents and accept them. If necessary, the committee may request additional materials or clarifications.
- Applications may be rejected if false information is included in the application or if requested materials are not submitted despite a request for supplementation.
d. Review of Advanced Regenerative Medicine Treatment Plans (Article 6 and 7 of the Draft)
- The treatment plan will be reviewed through the examination by expert committees and the decision of the review committee, and the committee may request supplementation or conduct on-site inspections if necessary.
- Regenerative medical institutions may request an extension of the supplementation period, but such requests are limited to two extensions.
e. Calculation of Review Period for Advanced Regenerative Medicine Treatment Plans (Article 8 of the Draft)
- The period spent on supplementing the application and documents will not be included in the review period, and the calculation of the processing period will follow the procedures specified in the Civil Petition Processing Act.
f. Submission of Documents During the Implementation of Advanced Regenerative Medicine Treatment (Article 9 of the Draft)
- Upon approval of the treatment plan, reporting must follow the designated reporting schedule, including the registration of treatment subjects, adverse reactions, and actions taken.
- A final report must be submitted to the review committee within 20 days of the end of observation for the final treatment subjects, and a result report must be submitted within 90 days, including safety and efficacy evaluation data.
g. Modification of Advanced Regenerative Medicine Treatment Plans (Article 10 of the Draft)
- If a regenerative medical institution wishes to modify the treatment plan, it must report the related changes. If significant changes occur, the treatment plan must be reviewed by the review committee again.
