This Act is specifically formulated to ensure the safety, quality, and effectiveness of regenerative medicine and to safeguard patient rights and medical ethics.

The competent authorities mentioned in this Act: The Ministry of Health and Welfare at the central level, the municipality governments at the municipality level, and the county (city) governments at the county (city) level.

The terms in this Act are defined as follows:
1. Regenerative medicine: Products or techniques that utilize genes, cells, and their derivatives for the treatment, repair, or replacement of human cells, tissues, and organs.
2. Regenerative medicinal products (hereinafter referred to as “regenerative products”): Products containing genes, cells, and their derivatives intended for human use.
3. Regenerative medicine techniques (hereinafter referred to as “regenerative techniques”): Regenerative medicine techniques performed on the human body. The following techniques are not included:
(1)Blood transfusion.
(2)Use of the plasma derivatives.
(3)Bone marrow hematopoietic and peripheral blood hematopoietic stem cell transplantation.
(4)Assisted reproduction.
(5)Other techniques announced by the central competent authority.
4. Regenerative medicine human trials (hereinafter referred to as “human trials”): Research conducted on human subjects at teaching hospitals or medical care institutions approved by the central competent authority to discover or demonstrate the clinical, pharmacological, or therapeutic effects of regenerative products or techniques for disease treatment.
5. Regenerative medicine cell bank (hereinafter referred to as “cell bank”): A place or facility for storing, processing, or providing human tissues, cells, or their derivatives for regenerative medicine.
6. Regenerative medicine biotechnology and pharmaceutical company: Biotech and pharmaceutical companies established under the Company Act to develop, manufacture, or be contracted to develop and manufacture products or techniques related to regenerative medicine.

The implementation of regenerative medicine shall comply with the ethical norms of regenerative medicine. The content of such norms shall be promulgated by the central competent authority.
The central competent authority shall formulate regenerative medicine development policies and promotion plans and review and revise them regularly to promote regenerative medicine.
The competent authorities at all levels may request relevant agencies (institutions), schools, juridical persons, or organizations to assist in promoting the foregoing plans.

The central competent authority shall establish a Regenerative Medicine Review Board (hereinafter referred to as “Review Board”) with a certain number of members, including medical, pharmaceutical, biotech, ethical, legal, and other relevant professional scholars and experts, as well as patient advocacy organizations. The Ministry of Health and Welfare or its Minister shall appoint a member to serve as the convener.
The preceding Review Board shall handle the following regenerative medicine matters:
1. Consultation on development, innovation, and promotion policy.
2. Consultation on the promotion of correct knowledge and concepts.
3. Consultation on the improvement of patient safety and healthcare quality.
4. Consultation on the promotion of talent development.
5. Consultation and review of research development, awards, and subsidies.
6. Consultation on the management of regenerative products and regenerative techniques
7. Review of conditional approval for regenerative products.
8. Consultation on implementation effectiveness evaluation.
9. Consultation on other matters related to regenerative medicine.
The composition, board member qualification, deliberation, conflict of interest recusal, and other regulation methods for the Review Board referred to in Paragraph 1 shall be determined by the central competent authority.
Either gender for the members of the Review Board referred to in Paragraph 1 shall not be less than one-third of the total members.

The central competent authority may entrust other government agencies (institutions), medical care institutions, academic research institutions, schools, juridical persons, or donate to establish medical care foundations when necessary to handle the following matters:
1. The screening of specific cell providers and the processing, preservation, and supply of their cells.
2. Processing and manufacturing of tissues and cells with advanced technologies.
3. Collection and preservation of master cells.
4. Recruit and promote human tissue and cell providers.
5. Other matters related to collaborating with the government in promoting regenerative medicine policies.
The central competent authority shall announce the entrustment methods and qualification requirements for the other government agencies (institutions), medical care institutions, academic research institutions, schools, or juridical persons specified in the preceding paragraph.