再生醫療法

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.

1The terms in this Act are defined as follows:

21. Regenerative medicine: Products or techniques that utilize genes, cells, and their derivatives for the treatment, repair, or replacement of human cells, tissues, and organs.

32. Regenerative medicinal products (hereinafter referred to as “regenerative products”): Products containing genes, cells, and their derivatives intended for human use.

43. Regenerative medicine techniques (hereinafter referred to as “regenerative techniques”): Regenerative medicine techniques performed on the human body. The following techniques are not included:

5(1)Blood transfusion.

6(2)Use of the plasma derivatives.

7(3)Bone marrow hematopoietic and peripheral blood hematopoietic stem cell transplantation.

8(4)Assisted reproduction.

9(5)Other techniques announced by the central competent authority.

1The 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.

2The central competent authority shall formulate regenerative medicine development policies and promotion plans and review and revise them regularly to promote regenerative medicine.

3The competent authorities at all levels may request relevant agencies (institutions), schools, juridical persons, or organizations to assist in promoting the foregoing plans.

1The 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.

2The preceding Review Board shall handle the following regenerative medicine matters:

31. Consultation on development, innovation, and promotion policy.

42. Consultation on the promotion of correct knowledge and concepts.

53. Consultation on the improvement of patient safety and healthcare quality.

64. Consultation on the promotion of talent development.

75. Consultation and review of research development, awards, and subsidies.

86. Consultation on the management of regenerative products and regenerative techniques

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1The 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:

21. The screening of specific cell providers and the processing, preservation, and supply of their cells.

32. Processing and manufacturing of tissues and cells with advanced technologies.

43. Collection and preservation of master cells.

54. Recruit and promote human tissue and cell providers.

65. Other matters related to collaborating with the government in promoting regenerative medicine policies.

7The 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.

Before implementing the regenerative technique, except for the circumstances specified in Article 8, Paragraph 1, human trials must be conducted and completed medical care institutions

1A medical care institution can be exempt from completing human trials for regenerative techniques under the following circumstances:

21. Treatment of life-threatening or severely disabling diseases for which no suitable drugs, medical devices, or medical techniques are available in the country.

32. Regenerative techniques that have been approved by the central competent authority for implementation by medical care institutions prior to the enforcement of this Act.

4The central competent authority shall announce the conditions, application procedures, case number restrictions, ethical standards, and other regulations for Subparagraph 1 of the preceding paragraph. However, the treatment shall exclude the utilization of xenogeneic cells and tissues.

5Before implementing the regenerative technique referred to in Paragraph 1, Subparagraph 1, a medical care institution shall apply to the central competent authority for approval on a case-by-case basis.

6A medical care institution implementing regenerative technique under Paragraph 1, Subparagraph 1, shall be exempt from applying for a drug license or conditional authorization according to the Regenerative Medicinal Products Act.

1Regenerative medical research involving embryos or embryonic stem cells shall not be conducted in the following methods:

21. Using artificial insemination to generate embryos.

32. Creating hybrids.

43. Introducing the cell nucleus of other species into enucleated human oocytes.

54. Reproducing embryos that have been used for research.

65. Implanting embryos that have been used for research into the uterus of a human or other species.

76. Creating or reproducing chimeric species with human germ cells.

87. Using materials or research methods prohibited by the central competent authority.

1The central competent authority or the central competent authority for special purpose undertakings may provide awards or subsidies to support research and development for regenerative medicine.

2The methods for the recipients, conditions, application procedures, award or subsidy methods, review criteria, cancellation, and other matters related to the awards or subsidies mentioned in the preceding paragraph shall be determined by the central competent authority in consultation with the central competent authority for special purpose undertakings.

Non-medical care institutions are not allowed to implement regenerative medicine.

1A medical care institution shall apply for approval from the central competent authority before implementing a regenerative technique or using a regenerative product designated by the central competent authority. After obtaining approval, it shall register with the competent authority of the direct-jurisdiction municipality or county (city) before proceeding.

2The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the approval matters referred to in the preceding paragraph.

3The methods for designating regenerative products under Paragraph 1, the conditions and procedures for applying for approval, the validity period and renewal of approval, cancellation, changes in approved matters, fee review and collection, refunds, and other matters to be observed shall be determined by the central competent authority.

A physician who implements regenerative medicine shall be a specialist in the relevant field of the disease. The central competent authority shall announce the qualifications for such physicians.

1Medical care institutions perform regenerative techniques that require to conduct cell culture, processing, and preservation (collectively referred to as “cell operation”) can do themselves or commission regenerative medicine biotechnology and pharmaceutical companies or medical care institutions (collectively referred to as “commissioned institutions”) to do so when necessary.

2The medical care or commissioned institutions performing cell operation under the preceding paragraph shall be exempt from obtaining a drug manufacturing license under the Pharmaceutical Affairs Act. Before performing cell operation, said institutions shall be inspected and approved by the central competent authority.

3The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the inspection, approval, and other related management matters referred to in the preceding paragraph.

4The methods, facilities, equipment, control measures, distribution, operator qualifications and required related training, inspection, application conditions and procedures for approval, validity period and renewal, cancellation, changes in approval matters, and other regulations to be observed for cell operation by medical care or commissioned institutions referred to in Paragraph 2 shall be determined by the central competent authority.

1Before implementing regenerative medicine, a medical care institution shall explain to the patient or his/ her legal representative, spouse, relatives, or related persons the possible effects and adverse reactions, costs, relief measures, and other necessary matters.

2Before implementing regenerative medicine, a medical care institution shall obtain the consent of the patient or his/ her legal representative, spouse, relatives, or related persons and sign a consent form before proceeding.

3The central competent authority shall determine the content of the consent form under the preceding paragraph.

1A medical care institution that uses regenerative products designated by the central competent authority or implements regenerative technique shall keep records for at least fifteen years and register the items designated by the central competent authority in the information system established by the central competent authority. However, records of minors shall be kept for at least fifteen years after they reach adulthood.

2The content of the records under the preceding paragraph shall include the date, place, and procedure of use or implementation, the regenerative products used, the regenerative technique implemented, serious adverse events, and other matters designated by the central competent authority.

When performing cell operation, a medical care institution or commissioned institution shall ensure the suitability of the human tissue and cell sources, except for tissues and cells obtained from a cell bank established with the approval of the central competent authority.

1The establishment of a cell bank shall be approved by the central competent authority. The cell bank may charge fees for preserving human tissues and cells and shall ensure the suitability of the tissue and cell sources.

2The central competent authority shall establish the qualifications, application conditions and procedures, preservation items, validity period and extension of permits, revocation, changes in permitted matters, required facilities, equipment and personnel qualifications, quality management, fee review and collection, refunds, commercial use profit sharing and other compliance matters for the establishment of cell banks mentioned in the preceding paragraph.

3The central competent authority shall establish the methods for determining the suitability of providers under the previous article and Paragraph 1, including selection, testing items, and other related matters.

4The central competent authority may entrust its subordinate agencies or other agencies (institutions), juridical persons, or organizations to handle the approval and other related management matters under Paragraph 1.

1Providers for the regenerative medicine tissues and cells obtained by a medical care institution or cell bank establishment shall be limited to adults who are competent adults. However, this shall not apply to those clearly beneficial for treating a specific population and cannot be replaced by other subjects.

2The providers must provide prior written consent before the tissues and cells under the preceding paragraph can be collected.

3If the provider is a person with limited capacity or under assistance declaration, the written consent must be obtained from both the donor and their legal representative or assistant. If the provider is a person without capacity or under guardianship declaration, the written consent must be obtained from their legal representative or guardian.

4If the provider is without decision-making capacity and the procedures in the preceding paragraph cannot be followed, written consent should be obtained from the following persons in order:

51. Spouse.

62. Adult children.

73. Parents.

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1Before obtaining consent under the preceding article, the following matters shall be informed:

21. The name of the institution.

32. The method of obtaining tissues and cells, the possible side effects and complications, the incidence rate and treatment methods, contraindications, limitations, and other related matters to be cooperated with.

43. The suitability criteria for providers.

54. The subsequent disposal or possible scope of use of the remaining tissues and cells.

65. The content and methods of subsidies for the providing behavior.

76. Subsequent follow-up content and methods.

87. The right to withdraw, suspend, and terminate.

98. Medical care, compensation, and handling of adverse reactions that may occur while obtaining tissues and cells.

1Except for advertisements to recruit regenerative product tissue and cell providers shall be issued by pharmaceutical companies, regenerative medicine tissue and cell provider recruitment advertisements (hereinafter referred to as “recruitment advertisements”) are limited to medical care institutions approved for implementing regenerative medicine, tissue storage institutions or cell banks that store tissues and cells, and other government agencies (institutions), medical care institutions, academic research institutions, schools, juridical persons, or medical care foundations established through donations that are entrusted by the central competent authority according to Article 6, Paragraph 1, Subparagraph 4.

2Advertisements for regenerative medicine shall only be conducted by medical care institutions approved to perform regenerative medicine. Advertisements for regenerative products must comply with the regulations for advertisement of medicaments under the Pharmaceutical Affairs Act.

1Recruitment and regenerative medicine advertisements (hereinafter collectively referred to as “advertisements”) shall not be marked, advertised, or publicized with exaggerated, untrue, or scientifically unproven therapeutic efficacy.

2Prior to broadcasting the advertisements mentioned in the preceding paragraph, the advertiser must register the content, broadcasting method, broadcasting documents, and video/audio recording content in the information system established by the central competent authority. After obtaining approval from the central competent authority or its entrusted or commissioned agencies (institutions) or juridical persons, the commissioned media company can broadcast the advertisements after providing the approval documents. Changes to the originally approved advertisement content or broadcasting method are not permitted during the broadcasting period without prior approval.

3If the competent authority of the municipality or county (city) finds that the content of an advertisement violates the provisions of Paragraph 1 or the preceding paragraph, it shall order the immediate cessation of broadcasting and require rectification within a specified deadline. If the rectification is not completed within the specified deadline, the broadcasting shall be prohibited, and the central competent authority, organization, or juridical persons mentioned in the preceding paragraph shall be notified to revoke its approval.

4The methods for the words, phrases, pictures, or other contents that may or may not be broadcasted in advertisements under Paragraph 1, the recruitment targets, broadcasting methods, broadcasting locations, and other compliance matters shall be determined by the central competent authority.

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1Broadcasters shall not broadcast advertisements that have not been approved, do not conform to approved matters, have been disapproved, have been ordered to be immediately discontinued, or have been prohibited from continuing to be broadcast.

2Broadcasters who accept commissions to broadcast advertisements shall preserve the content of the commissioned advertisements, the name, address, and telephone number of the commissioned broadcasting agency, and copies of the approval documents under Paragraph 2 of the preceding article for six months from the date of broadcasting the advertisements. If the entity commissioning the broadcast is a medical care institution, it must also retain the business license number.

3When the competent authority requests the provision of the documents and data under the preceding paragraph, the broadcaster shall not evade, obstruct, or refuse.

1Medical care institutions that perform regenerative techniques under Paragraph 1 of Article 8 and Paragraph 1 of Article 12 shall submit a results report within six months after the end of each year or within the deadline notified by the central competent authority.

2The report’s content under the preceding paragraph shall include the number of cases, treatment effects, adverse events, and other matters designated by the central competent authority.

3The central competent authority shall disclose the medical care institutions’ treatment effects and statistical medical quality information annually under Paragraph 1 to protect the rights of the public.

Medical care institutions that use regenerative products designated by the central competent authority or perform regenerative techniques shall establish a long-term tracking mechanism. In the event of a serious adverse reaction, it must report to the central competent authority. The methods for reporting, including the deadline, manner, content, and other compliance matters, shall be determined by the central competent authority.

1If a medical care institution has any of the following circumstances that can affect the rights and safety of patients, the central competent authority may order it to suspend or terminate all or part of the regenerative medicine implementation and announce the matter:

21. Violating the matters announced by the central competent authority that must be complied with under Article 8, Paragraph 2 or performing regenerative medicine contents without approval by the central competent authority according to Article 12, Paragraph 1.

32. The number or severity of adverse events is abnormally high.

43. Failure to report as required by the front portion of the previous paragraph.

54. Failure to comply with the provisions of Article 14, Paragraph 4, when performing cell manipulation.

65. Other circumstances that seriously affect the rights and safety of patients.

7If a medical care institution voluntarily suspends or terminates all or part of the regenerative medicine approved under Article 12, Paragraph 1, it shall first state the reasons and apply to the central competent authority for approval.

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1Medical care institutions that perform regenerative techniques under Article 8, Paragraph 1, Subparagraph 2 or Article 12, Paragraph 1 shall have relief measures formulated in case of adverse reactions that cause serious injury or death. The central competent authority shall announce the method, scope, and other compliance matters.

2The relief measures under the preceding paragraph may be implemented by purchasing relevant liability insurance.

1If a non-medical care institution has any of the following circumstances, it shall be punished with a fine of not less than NT$2 million and not more than NT$20 million:

21. Violating the provisions of Article 11 and performing regenerative medicine.

32. Violating the provisions of Article 21, Paragraph 2, and advertising regenerative medicine.

4If any of the following circumstances exist, a fine of not less than NT$200,000 and not more than NT$2 million shall be imposed:

51. Violating the provisions of Article 7 and not conducting or completing human trials before performing regenerative medicine.

62. Violating the provisions of Article 8, Paragraph 3, by performing the regenerative technique under Paragraph 1, Subparagraph 1 of the same article without approval from the central competent authority.

73. Violating the second portion of the provisions of Article 14, Paragraph 2, by performing cell manipulation without a permit.

84. Violating the provisions provided by the front portion of Article 18, Paragraph 1, by establishing a cell bank without a permit.

1If any of the following circumstances exist, a fine of not less than NT$200,000 and not more than NT$2 million shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:

21. Violating the provisions of the cell manipulation methods, control measures, distributions, or licensing matters as provided by Article 14, Paragraph 4.

32. Violating the provisions of Article 17 or Article 18, Paragraph 1, and failing to ensure the suitability of providers.

43. Violating the provisions of Article 18, Paragraph 2, regarding the items to be preserved, changes in licensing matters, the facilities, equipment, quality management, fee collection, refunds, or commercial use profit sharing.

54. Violating the provisions of Article 22, Paragraph 3, and broadcasting advertisements that have been disapproved, ordered to be immediately discontinued, or prohibited from continuing to be broadcast.

65. Violating the provisions of Article 22, Paragraph 4, regarding the places where advertisements may be broadcast.

76. Violating the provisions of Article 22, Paragraph 5, by advertising regenerative techniques under Article 8, Paragraph 1, Subparagraph 1.

1If a medical care institution violates the provisions of Article 12, Paragraph 1, by performing regenerative techniques or using regenerative products designated by the central competent authority without approval and registration, said institution shall be punished with a fine of not less than NT$100,000 and not more than NT$1 million, and its name may be published.

2If any of the following circumstances exist, a fine of not less than NT$100,000 and not more than NT$1 million shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:

31. Violating the provisions under Article 12, Paragraph 3, regarding changes in licensing matters, fee collection, or refunds.

42. Violating the provisions of Article 27, Paragraph 1; having no relief measures; or the measures do not conform to the provisions announced by the central competent authority.

5In addition to the penalties under the first subparagraph of the preceding paragraph, the person’s name may also be published if there is a violation under the first subparagraph of the preceding paragraph.

6If an order is issued under Paragraph 2 to limit the time for improvement, and the progress is not made within the improvement period or the prescribed deadline, the regenerative medicine implementation work may be ordered to be suspended in whole or in part. If the circumstances are serious and there is a fact of damage to the life, body, or health of patients, or there is a risk of harm, the whole or part of the approved matters may be revoked.

1If any of the following circumstances exist, a fine of not less than NT$50,000 and not more than NT$500,000 shall be imposed:

21. Conducting regenerative medicine research involving embryos or embryonic stem cells in the manner prescribed in Article 9.

32. The physician performing regenerative medicine does not meet the qualifications announced by the central competent authority according to the latter portion of Article 13.

43. Violating the provisions of Article 14, Paragraph 4, regarding the qualifications of cell manipulation personnel.

54. Violating the provisions of the methods under Article 18, Paragraph 2, regarding the qualifications of cell bank personnel.

65. Violating the provisions of Article 19, Paragraph 1, as the provider is an adult without the capacity to make decisions.

76. Violating the provisions of Article 23, Paragraph 2, by failing to preserve data within the prescribed deadline or preserving incomplete data.

1If any of the following circumstances exist, a fine of not less than NT$50,000 and not more than NT$500,000 shall be imposed, and a deadline shall be set for improvement. If the improvement is not made within the prescribed deadline, the penalty shall be repeated until the improvement is made:

21. Violating the provisions of the methods under Article 14, Paragraph 4, regarding the requirement for cell manipulation personnel to complete relevant training.

32. Violating the provisions of Article 15, Paragraph 1, and failing to provide relevant explanations before performing regenerative medicine.

43. Violating the provisions of Article 15, Paragraph 2, and failing to obtain a consent form before performing regenerative medicine.

54. Failing to make records or preserve or register information systems according to the provisions of Article 16, Paragraph 1.

65. The record content did not include the matters stipulated in Article 16, Paragraph 2.

76. Violating the provisions of Article 19, Paragraph 2, by failing to obtain the provider’s written consent before obtaining tissues and cells or failing to handle the exercise of the right to consent per the provisions of Paragraphs 3 to 6 of the same Article.

For the fines stipulated in this Act, the responsible physicians for private medical care institutions shall be punished. For medical care institutions established by juridical persons in medical care, the juridical persons in medical care shall be punished.

The enforcement rules for implementing this Act shall be prescribed by the central competent authority.

The date of commencement for this Act shall be determined by the Executive Yuan.