1. Reason for Revision

Since the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products has been revised (Law No. 20331; Promulgated on February 20, 2024; effective from February 21, 2025) to introduce an advanced regenerative medicine treatment system and to expand the scope of clinical research subjects so as to allow advanced regenerative medicine, which has so far been restricted to limited clinical research, to be used in patient treatments, the proposed revision stipulates the matters delegated by the Act and the matters necessary for its implementation.

2. Main Contents

a. Recording and reporting of advanced regenerative medical treatments (Article 5 of the draft)

- The revision adds requirements for regenerative medicine institutions to include information on the notification and collection of treatment fees, as well as implementation outcomes, in their reports to the safety management institution through the information system.

b. Education and training of the personnel of regenerative treatment institutions (Article 5-2 of the draft)

- The revision requires the personnel of regenerative medical treatment institutions to complete the education and training provided by the Minister of Health and Welfare in order to improve their expertise in conducting advanced regenerative medicines and to protect the patients.

c. Survey and disclosure of the costs of advanced regenerative medical treatments (Article 7-2 of the draft)

- The Minister of Health and Welfare may annually request cost information collected in the information system from the head of the safety management institution for investigation and analysis and may publish the results on the website of the Ministry of Health and Welfare.

d. Consent to Advanced Regenerative Medical Treatments (Article 8-2 of the draft)

- The revision adds information related to the processing and protection of personal information and the discontinuation of treatment to the information for which a regenerative medical institution must obtain consent from the patient before providing treatment, in addition to information prescribed by the law, such as the method of and consent to treatment.

e. Reporting and Investigation of Adverse Reactions (Articles 16 to 17 of the draft)

- The revision classifies adverse reactions into seriously adverse and other adverse reactions. The head of the safety management organization is required to publish the matters necessary for the reporting and investigation thereof.