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The Regulations For Regenerative Medicine Dual Legislation Take Effect in 202
The Regulations For Regenerative Medicine Dual Legislation Take Effect in 2026
Katherine Juang / Rose Huang / Zoe Cho
In response to the rapid development of emerging biomedical technologies in recent years, the regulatory framework for regenerative medicine underwent several years of drafting in multiple versions, the Regenerative Medicine Act and the Regenerative Medicinal Products Act (collectively, the “Regenerative Medicine Dual Legislation”) were ultimately passed upon the third reading by the Legislative Yuan on June 4, 2024, promulgated by the President on June 19 of the same year. Following more than one year of drafting and promulgation of subordinate regulations by the competent authority, the Ministry of Health and Welfare (“MOHW”), the Executive Yuan has designated January 1, 2026, as the official effective date of the Regenerative Medicine Dual Legislation.
The Regenerative Medicine Dual Legislation aims to establish a comprehensive regulatory framework covering the medical practice end, the medicinal product end, and the cell preparation end, so as to address practical regulatory needs and enhance the protection of patients’ rights and interests.
Overall, the regulatory framework under the Regenerative Medicine Dual Legislation can be divided into two major dimensions: the “technology” dimension and the “product” dimension. The Regenerative Medicine Act focuses on clinical research and the execution standards of regenerative medicine technologies, while the Regenerative Medicinal Products Act emphasizes the approval and management of the manufacturing, importation, distribution, and advertising of regenerative medicinal products. The key points are summarized as follows:
I. Regenerative Medicine Act
1. Authorized Practitioners of Regenerative Medicine
Regenerative medicine may only be performed by medical institutions, and the physicians carrying out such treatments must be specialists in medical fields relevant to the diseases concerned. Any non-medical institution that unlawfully performs regenerative medicine shall be subject to an administrative fine ranging from NTD 2 million to NTD 20 million, and the competent authority may confiscate the relevant equipment and regenerative medicine products.
2. Principle and Exceptions Regarding Human Subject Trials
In principle, prior to performing regenerative medicine technologies, medical institutions must conduct and complete human subject trials to ensure safety and efficacy. However, the requirement for human subject trials may be exempted under the following circumstances:
- Treatment of life-threatening diseases or diseases that may result in severe disability, where no appropriate pharmaceuticals, medical devices, or medical technologies are available domestically (i.e., compassionate use).
- Regenerative medicine technologies that had already been approved by the central competent authority for implementation by medical institutions prior to the enforcement of the Act.
3. Qualifications and Consent of Research Source Providers
Providers of tissues or cells used in regenerative medicine must, in principle, be adults with capacity for consent, and their prior written consent must be obtained.
Where the provider is a person with limited capacity, a person under assistance or guardianship declaration, a person without legal capacity, or an adult without capacity for consent, additional safeguards apply. In such cases, written consent from the legal representative or guardian is required, and such consent must be notarized to become legally effective.
4. Relevant Subordinate Regulations
The MOHW has announced several subordinate regulations under the Regenerative Medicine Act on November 17, December 2, and December 26, 2025, including the Regulations on the Management of the Regenerative Medicine Review Committee Organization and Operation, Regulations on Regenerative Medicine Research and Development Incentives, Regulations on the Management of Regenerative Medicine Treatment and Designated Products, Regulations on Institutions Obtaining Informed Consent for Regenerative Medicine Tissues or Cells, Regulations on the Broadcasting of Advertising and Recruitment for Regenerative Medicine, Regulations on Severe Adverse Reaction Reporting for Regenerative Medicine Treatment, Regulations on Regenerative Medicine Cell Manipulation, Regulations on Suitability Assessment for Tissue and Cell Providers, and Standards on the Fees for Licensing the Operation of Regenerative Medicine Cells and the Establishment of Cell Banks.
II. Regenerative Medicinal Products Act
1. Regulation of Manufacturing and Importation of Regenerative Medicinal Products
In principle, the manufacture or importation of regenerative medicinal products requires an application for inspection and registration with the central competent authority and approval for a marketing authorization (“MA”).
To accelerate the clinical use of promising products, the Regenerative Medicinal Products Act introduces a “conditional approval” mechanism, allowing regenerative medicinal products that have completed Phase II clinical trials and demonstrated safety and preliminary efficacy to obtain conditional approval for a period of up to five years, subject to review and approval by the Regenerative Medicine Review Committee.
If the MA holder fails to comply with the conditions imposed, or if a significant safety concern is identified upon evaluation, the MOHW may revoke the conditional approval. This mechanism shortens the review timeline for market entry of innovative products, enabling timely treatment of life-threatening or severely disabling diseases and promoting the development of the regenerative medicine industry.
In addition, the Regenerative Medicinal Products Act serves as a special law under the Pharmaceutical Affairs Act; therefore, matters not specifically regulated under it shall be governed by the Pharmaceutical Affairs Act.
2. Qualifications of Research Source Providers
For tissues or cells used in the manufacture of regenerative medicinal products, the providers must, in principle, be adults with capacity for consent and must provide written consent. However, where the use of such materials is clearly beneficial to the treatment of specific population groups and cannot be substituted by other sources, this requirement may be exempted. Violations of the foregoing provisions are subject to administrative fines ranging from NTD 30,000 to NTD 2 million.
3. Relief Mechanisms for Adverse Reactions
Where the use of regenerative medicinal products results in adverse reactions causing death, disability, or serious illness, the applicable relief mechanism depends on the type of regulatory approval granted:
- For products under conditional approval, relief shall be provided in accordance with the measures specified in the conditions of approval.
- For products that have obtained a MA, the Drug Injury Relief Act shall apply.
4. Relevant Subordinate Regulations
The MOHW has gradually promulgated subordinate regulations under the Regenerative Medicinal Products Act, including the Regulations on the Management of Regenerative Medicine Product Safety Monitoring (August 25, 2025), the Regulations on Supply Source and Flow Data Preservation for Regenerative Medicine Products (October 28, 2025), the Regulations on Recruitment and Advertising for Providers of Tissue and Cells for Regenerative Medicine Products (November 20, 2025), the Regulations on Informed Consent for Donors of Tissues and Cells for Regenerative Medicinal Products (December 1, 2025), the Regulations on Inspection, Registration, and Licensing Review of Regenerative Medicinal Products (December 4, 2025), the Regulations on Donor Eligibility Assessment for Tissues and Cells for Regenerative Medicinal Products (December 9, 2025), and the Standards on the Review Fees of Regenerative Medicinal Products (December 29, 2025).
Should industry participants require further analysis regarding the regulatory framework, compliance strategies, or practical application of the Regenerative Medicine Dual Legislation, our firm has established a "Pharmaceuticals and Biotechnology Practice Group", and we welcome you to contact our professionals for further assistance.