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. Classification of degree of risk of advanced regenerative medicine (Article 4 of the draft)

- The revision provides the grounds for reclassifying the level of risk posed by advanced regenerative medicines after deliberation by the review committee when sufficient research data have been accumulated, etc.

b. Guidelines for advanced regenerative medical treatment (Article 10 of the draft)

- The revision stipulates the rules to be followed by treatment institutions, including compliance with the treatment plan, safety management of human cells, and checking of the health status of the recipients.

c. Submission and review of plans for advanced regenerative medical treatment (Article 11-2 and Article 12 of the draft)

- The revision stipulates the contents, data and materials to be submitted by a regenerative medical institution when applying for an advanced regenerative medical treatment plan, and stipulates the deliberation procedure of the review committee.

d. Request for advanced regenerative medicine data (Article 14-2 and Article 16 of the draft)

- The review committee is empowered to request data concerning the progress and results of advanced regenerative medicines from regenerative medical institutions, and to review the submitted data and allow safety management organizations to investigate them as required.

e. Organization of specialized committees (Article 15 of the draft)

- In order to secure efficiency and expertise in reviewing plans for advanced regenerative medications, the amendment increases the size of the expert committees, and allows the addition of specialized committees for areas deemed necessary by the review committee.

f. The matters to be considered in the review of plan for advanced regenerative medicine treatment (Article 16 of the draft).

- The review committee is required to examine or consider the suitability or acceptability of the patient and the cost of the treatment, as well as the safety, efficacy, etc. as provided by the law when it reviews plans for advanced regenerative medicine treatment.

g. Duties of the Safety Management Organization (Article 23 of the draft)

- The safety management organization will also operate an information system, and analyze and evaluate information concerning advanced regenerative medicines, etc.

h. Measures based on the results of investigations of adverse reactions caused by advanced regenerative medical treatments (Article 25 of the draft).

- The Minister of Health and Welfare is empowered to take the measures necessary to protect public health, such as suspension of a treatment and similar treatments, and to conduct epidemiological investigations in order to determine the causes of adverse reactions based on the results of such investigations.

i. Delegation or entrustment of authority or duties (Article 41 of the draft)

- The Minister of Health and Welfare is authorized to entrust the training of personnel of regenerative medical institutions, and investigation and analysis of the current status of treatment costs, etc. to an advanced regenerative medical support organization.