Newsletter
The draft regulations for the regenerative medicine dual legislation have been published sequentially, with ongoing updates in progress.
The dual legislation on regenerative medicine, comprising the Regenerative Medicine Act and the Regenerative Medicine Product Act, was announced by the President on June 19, 2024. Following this announcement, the central competent authority, the Ministry of Health and Welfare (MOHW), began drafting various regulations authorized under these acts.
Recently, on February 17, 2025, the MOHW announced the following draft regulations for the Regenerative Medicine Act:
1. Draft "Regulations on the Management of the Regenerative Medicine Review Committee Organization and Operation," announced in accordance with Article 5, Paragraph 3 of the Act.
2. Draft "Regulations on Regenerative Medicine Research and Development Incentives," announced in accordance with Article 10, Paragraph 2 of the Act.
3. Draft "Regulations on the Management of Regenerative Medicine Treatment and Designated Products," announced in accordance with Article 12, Paragraph 3 of the Act.
4. Draft "Regulations on Institutions Obtaining Informed Consent for Regenerative Medicine Tissues or Cells," announced in accordance with Article 20, Paragraph 2 of the Act.
5. Draft "Regulations on the Broadcasting of Advertising and Recruitment for Regenerative Medicine," announced in accordance with Article 22, Paragraph 4 of the Act.
6. Draft "Regulations on Severe Adverse Reaction Reporting for Regenerative Medicine Treatment," announced in accordance with Article 25 of the Act.
Additionally, the MOHW has announced the following draft regulations for the Regenerative Medicine Product Act:
1. Draft "Regulations on the Management of Regenerative Medicine Product Safety Monitoring," announced on August 19, 2024, in accordance with Article 17, Paragraph 3 of the Act.
2. Draft "Regulations on Supply Source and Flow Data Preservation for Regenerative Medicine Products," announced on January 15, 2025, in accordance with Article 18, Paragraph 2 of the Act.
3. Draft "Regulations on Recruitment and Advertising for Providers of Tissue and Cells for Regenerative Medicine Products," announced on February 6, 2025, in accordance with Article 15, Paragraph 6 of the Act.
4. Draft "Regulations on Informed Consent for Providers of Tissue and Cells for Regenerative Medicine Products," announced on February 13, 2025, in accordance with Article 13, Paragraph 2 of the Act.
All of the aforementioned draft regulations have been or will be subject to public consultation within 60 days of their announcement. Furthermore, several additional regulations authorized under the regenerative medicine dual legislation are still pending drafting. The MOHW will continue to announce relevant subsidiary regulation drafts. According to recent news reports, the MOHW aims to complete the announcement and implementation procedures for these subsidiary regulations by the end of 2025 to facilitate the official implementation of the Regenerative Medicine Act and the Regenerative Medicine Product Act. Our firm will closely monitor the implementation schedule.
Our firm has a "Life Sciences & Healthcare" practice group with a team of experts specializing in regenerative medicine laws. Please feel free to contact us for further analysis or consultation.