Series Articles of the Regenerative Medicine Dual Legislation (5) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicine Act (Taiwan)

The Legislative Yuan of Taiwan passed the "Regenerative Medicine Act" and the "Regenerative Medicinal Products Act" (collectively referred to as the "Regenerative Medicine Dual Legislation") on June 4, 2024. The Regenerative Medicine Dual Legislation will officially take effect once the Executive Yuan establishes an implementation date.

The Ministry of Health and Welfare (hereinafter referred to as the "MOHW") has not only announced draft subsidiary regulations for the Regenerative Medicinal Products Act but has also promulgated six subsidiary regulations under the Regenerative Medicine Act on February 17, 2025. The related draft measures address matters including: (1) organization and operational management of the Regenerative Medicine Review Committee, (2) incentives for research and development in regenerative medicine, (3) management of regenerative medicine technologies and designated preparations, (4) informed consent for institutions acquiring regenerative medical tissues or cells, (5) regulations on regenerative medicine advertisements and recruitment advertisements, and (6) reporting of severe adverse reactions related to regenerative medicine technologies. This article will focus on key highlights of the above six draft regulations.

I. Draft of the "Regulations of the Organization and Operational Management of the Regenerative Medicine Review Committee"

In accordance with Article 5, Paragraph 3 of the Regenerative Medicine Act, the MOHW is responsible for formulating the Draft of the "Regulations of the Organization and Operational Management of the Regenerative Medicine Review Committee" (hereinafter referred to as "Regulation One") to provide consultation and review services on matters related to regenerative medicine.

Regulation One clearly defines the duties and the procedures for deliberating and deciding matters of the Regenerative Medicine Review Committee (hereinafter referred to as the "Committee"). It also establishes provisions concerning the qualifications of Committee members, conflict-of-interest policies, and confidentiality obligations for Committee members, thereby clarifying its role. The key points are summarized as follows:

(1) Duties of the Committee

The Committee is responsible for providing consultation and review on matters related to regenerative medicine, including the management of regenerative medicine preparations and technologies, granting conditional approvals for regenerative medicine preparations, and evaluating implementation effectiveness (Article 2 of the Regulation One).

(2) Composition of the Committee

The Committee shall be composed of experts and scholars specializing in medicine, pharmaceuticals, biotechnology, ethics, and law, as well as representatives from patient advocacy groups. Members of any single gender shall comprise no less than one-third of the total number of committee members (Article 3 of the Regulation One).

(3) Term Length, Renewal, and Dismissal of Committee Members

The term of office for committee members is two years, and they may be reappointed upon expiration. However, to uphold the professionalism and credibility of the Committee, members shall be dismissed or not reappointed if they engage in misconduct, violate gender equality regulations, exploit their position for personal gain, or exhibit other behaviors deemed unsuitable (Article 4 of the Regulation One).

(4) Committee Meetings

Committee members must attend meetings in person and may not appoint proxies. The Committee shall convene twice a year. A meeting may only be held if more than half of all Committee members are present, and decisions must be approved by a majority vote of attending members (Article 5 of the Regulation One).

(5) Conflict of Interest and Confidentiality Obligations

Committee members must comply with the relevant provisions of Article 32 (self-recusal) and Article 33 (recusal upon request) of the Administrative Procedure Act when a conflict of interest arises.

Committee members and attendees must maintain confidentiality regarding any meeting-related information or proceedings they become aware of or obtain. Preparatory documents and deliberation processes of the Committee shall not be disclosed in accordance with the provisions of the Freedom of Government Information Law (Articles 6 and 7 of the Regulation One).

II. Draft of the "Regulations of the Regenerative Medicine Research and Development Incentive Measures"

Pursuant to Article 10, Paragraph 2 of the Regenerative Medicine Act, the MOHW is responsible for formulating the draft of the "Regulations of the Regenerative Medicine Research and Development Incentive Measures" (hereinafter referred to as "Regulation Two"). Regulation Two aims to enhance the development of the regenerative medicine industry by providing incentives or subsidies. It clearly stipulates the eligible recipients, conditions, application procedures, methods, review criteria, termination, and other related matters of such incentives or subsidies to encourage domestic entities to invest in regenerative medicine research.

Natural persons, legal entities, groups, institutions (organizations), or schools that (1) engage in clinical research related to regenerative medicine, improve or innovate treatment technologies or schemes, and enhance the clinical application and development of regenerative medicine; or (2) comply with the policies of the central competent authority and contribute to the development of the domestic regenerative medicine industry with tangible achievements, may be awarded certificates, trophies, or medals as incentives (Articles 2 and 3 of the Regulation Two).

Applications for incentives must be accompanied by relevant documents proving the items for which incentives are sought, specific contributions, or achievements. These applications should be submitted to the central competent authority within the specified items, conditions, and period (Article 4 of the Regulation Two).

III. Draft of the "Regulations of Regenerative Medicine Technology and Designated Preparations Management"

In accordance with Paragraph 3, Article 12 of the Regenerative Medicine Act, the MOHW has formulated the draft of the "Regulations of Regenerative Medicine Technology and Designated Preparations Management" (hereinafter referred to as "Regulation Three"). Regulation Three further sets out detailed provisions regarding the designation, application, approval, revocation, and modification procedures for medical institutions implementing regenerative medical technologies or using designated regenerative preparations. The aim is to ensure that the central competent authority can rigorously manage the risks associated with regenerative medicine technologies, thereby safeguarding the safety, quality, and efficacy of regenerative medical treatments for patients. The key points are as follows:

(1) Qualifications and Conditions for Medical Institutions

For specific regenerative medicine projects, only hospitals or clinics that have passed evaluation or accreditation by the central competent authority or its designated professional institutions may apply to perform such projects. In cases involving the use of designated regenerative products indicated for cancer, eligible medical institutions are limited to hospitals that have obtained cancer treatment quality certification issued or commissioned by the central competent authority, or hospitals with special expertise as approved by the central competent authority. For designated regenerative products indicated for rare diseases or gene therapy, the medical institutions must be medical centers (Article 2 of the Regulation Three and Appendix 1).

(2) Restrictions on Human Tissue or Cell Sources

The sources of human tissues or cells used by medical institutions for executing regenerative technologies are limited to: (1) those obtained from the patient for the current treatment; (2) those obtained from cell operation facilities that have been legally permitted; or (3) those obtained from legally established cell banks (Article 5 of the Regulation Three).

(3) Application for Approval and Registration of Regenerative Technology Execution

Medical institutions executing regenerative technologies must submit documents such as physician qualification certificates, cell operation and cell bank permits, and regenerative technology execution plans to the central competent authority or its designated agencies, legal entities, or organizations for approval. They must also register with the competent authorities of the municipality or county (city) (Articles 3 and 4 of the Regulation Three).

(4) Review of the Use of Regenerative Medicinal Products

Medical institutions that use regenerative medicinal products with indications including cancer, rare diseases, or gene therapy must submit an application form and relevant documents to the central competent authority or its designated agencies, legal entities, or organizations commissioned or designated by the central competent authority for approval. They must also register with the competent authorities of the municipality or county (city) (Article 6 of the Regulation Three).

(5) Review of Changes in Regenerative Medical Treatment

Medical institutions shall execute regenerative medicine according to the approved content and period. If they intend to (1) amend the approved content; (2) resume all or part of the regenerative medicine procedures after termination or suspension; or (3) change the physician executing the regenerative medicine, they must apply for approval of such changes from the central competent authority and update their registration with the original competent authority of the municipality or county (city) (Article 8 of the Regulation Three).

(6) Informed Consent Prior to the Implementation of Regenerative Medical Treatment

Before executing regenerative medicine, medical institutions must inform patients or their legal representatives, spouses, relatives, or related persons of all legally required matters and obtain their consent. The procedure may only proceed after a written consent form is signed. The information provided must include the patient's condition, treatment plan, alternative treatment options, procedures, medications, possible effects and adverse reactions, costs, and relief measures (Article 10 of the Regulation Three).

(7) Fee Standards for Regenerative Medical Treatment

The fee standards for regenerative medical treatment provided by medical institutions must be approved by the competent authorities of the municipality or county (city). Fees should be charged in stages according to treatment phases and may not be collected in full as a lump-sum prepayment. Medical institutions must inform patients of the fee amount, payment methods and refund conditions. The approved fee standards must also be listed in the information system designated by the central competent authority (Article 11 of the Regulation Three).

(8) Transitional Arrangements for Regulation Three

Before the implementation of Regulation Three, if a medical institution has already obtained approval to execute cell therapy technologies under the Specific Medical Technology Inspection and Testing Medical Equipment Management Regulations (hereinafter referred to as "Special Management Regulations"), it may continue to execute such cell therapy technologies in accordance with the approved plan and the Specific Management Regulations within the originally approved period, without the need to reapply.  However, any application for modification or extension of the approval must be handled in accordance with Regulation Three.  In addition, for medical institutions that have applied to execute cell therapy technologies under the Special Management Regulations but have not yet been approved, they may still be subject to the review and approval regulations in effect at the time of application (Article 12 of the Regulation Three).

Medical institutions that execute regenerative technologies or use regenerative medicinal products designated by the central competent authority without prior approval and registration shall be fined between NT$100,000 and NT$1,000,000, and their names may be publicly disclosed. Violations of Regulation Three regarding changes in approved items, fee collection, or refund requirements will incur the same fines, with repeated penalties until improvements are made, and the names of violators may also be disclosed. During the improvement period, the central competent authority may order the suspension of part or all of the regenerative medical operations. If the violations are serious and pose a risk to patients' lives, bodies, or health, the central competent authority may revoke part or all of the approved items (Article 30, Paragraphs 1, 2(1), 3, and 4 of the Regenerative Medicine Act).

IV. Draft of the "Regulations for Obtaining Informed Consent for Regenerative Medical Tissues or Cells"

Pursuant to Article 20, Paragraph 2 of the "Regenerative Medicine Act," the MOHW has formulated the draft of the "Regulations for Obtaining Informed Consent for Regenerative Medical Tissues or Cells" (hereinafter "Regulation Four"). This regulation ensures that institutions clearly inform tissue/cell providers of their rights and risks before obtaining regenerative medical tissues or cells, safeguarding their decision-making autonomy.

Key provisions include the requirement that medical institutions or cell bank facilities must inform the donor (the person with consent authority), either in writing or verbally, of the matters specified in Article 20, Paragraph 1 of the Regenerative Medicine Act before collecting such tissues or cells. The consent form must be signed and dated by the person with consent authority and submitted to the institution. The content of the consent form must be reviewed and approved in advance by an ethics review committee, and consent must not be obtained through coercion, inducement, or any other improper means (Article 2 of the Regulation Four).

If the approved consent form is later found to lack critical information that could influence the donor’s decision, the institution must immediately submit a revised version to the ethics review committee for re-evaluation. For individuals who previously signed the consent form but whose tissues or cells have not yet been collected, renewed consent must be obtained before proceeding. Institutions must retain consent forms for at least 30 years from the date of receipt (Articles 4 and 5 of the Regulation Four).

Institutions that fail to inform providers of required matters before obtaining consent or violate Regulation Four’s procedures for disclosure and consent acquisition shall be fined between NT$50,000 and NT$500,000. Failure to rectify violations within the specified period will result in repeated fines until compliance is achieved (Article 32(7) and (8) of the Regenerative Medicine Act).

V. Draft of the "Regulations for Broadcasting Regenerative Medicine Advertisements and Recruitment Advertisements"

Pursuant to Article 22, Paragraph 4 of the "Regenerative Medicine Act," the MOHW has formulated the draft "Regulations for Broadcasting Regenerative Medicine Advertisements and Recruitment Advertisements" (hereinafter referred to as "Regulation Five"). This regulation provides detailed provisions regarding the content, broadcasting methods, and targets of recruitment advertisements.

Regulation Five clearly stipulates the permitted wording, language, images, and other elements that may be used in advertisements and imposes restrictions on the methods and locations of dissemination. These provisions aim to ensure transparency and accuracy of advertising information, prevent exaggeration or misleading content, and further protect the rights and autonomy of tissue/cell donors and patients. A summary of key points is as follows:

(1) Definition of Recruitment Advertisements and Regenerative Medicine Advertisements

Under Regulation Five, a recruitment advertisement refers to any advertisement aimed at recruiting donors of tissues or cells for regenerative medicine. A regenerative medicine advertisement refers to any advertisement disseminated through various media channels to promote regenerative medicine services—excluding those defined under Article 8, Paragraph 1, Subparagraph 1 of the Regenerative Medicine Act (commonly known as “compassionate use”)—for the purpose of soliciting patients to undergo regenerative treatments (Article 2 of Regulation Five).

(2) Application for Advertising Approval

Advertisers shall submit relevant information demonstrating their eligibility, along with details on the method, medium, content, and duration of the advertisement. These details must be registered in the information system established by the central competent authority. Advertisers must also apply for advertisement publication approval from the central competent authority or from an agency or legal entity commissioned or designated by it. (Article 3 of the Regulation Five).

(3) Methods and Content of Recruitment and Regenerative Medicine Advertisements

There are restrictions on the broadcasting of recruitment and regenerative medicine advertisements to ensure accurate and transparent information and protect public interests. For example, regenerative medicine advertisements can only include specific items such as the institution's name, address, approval documents, technical items, indications, medical personnel qualifications, and fee standards, aiming to safeguard patient rights and prevent exaggerated promotions (Articles 4 and 5 of the Regulation Five).

(4) Prohibited Content in Recruitment and Regenerative Medicine Advertisements

Recruitment advertisements must not claim harmlessness, exaggerate benefits, or use improper methods to induce providers. They must not contain content that disparages the techniques or reputation of competitors. Regenerative medicine advertisements must not claim harmlessness, exaggerate benefits, or use coercive or promotional methods to promote regenerative medical services (Articles 6 and 7 of the Regulation Five).

(5) Methods and Locations for Recruitment Advertisements

To prevent harm to individuals who may lack decision-making capacity, act hastily, or lack experience, recruitment advertisements shall, in principle, be directed only at competent adults. Such advertisements may not be published or broadcast within the campuses of senior high schools or below. (Article 9 of the Regulation Five).

(6) Validity Period of Approved Advertisements

Approved advertisements are valid for one year and can be extended upon application, provided that the extension request is submitted within three months before expiration. Each extension approval shall not exceed one year (Article 10 of the Regulation Five).

Publishing advertisements without prior approval, failing to provide approval documents to media agencies, or making unauthorized changes to the approved advertisement content or dissemination method shall be subject to a fine ranging from NT$200,000 to NT$2,000,000.

In cases where advertisements that have had their approval revoked, suspended, or prohibited are still published, or where advertisements are published in violation of location restrictions or involve unauthorized promotion of regenerative medicine technologies under compassionate use, a fine ranging from NT$200,000 to NT$2,000,000 shall also apply. If the violation is not rectified within the prescribed period, repeated fines may be imposed until compliance is achieved (Articles 28, Paragraphs 2(7) and Article 29, Paragraphs 1(4)-1(6) of the Regenerative Medicine Act).

VI. Draft of the "Regulations for Reporting Serious Adverse Reactions in Regenerative Medicine Technologies"

Pursuant to Article 25 of the "Regenerative Medicine Act," the MOHW has formulated the draft "Regulations for Reporting Serious Adverse Reactions in Regenerative Medicine Technologies" (hereinafter referred to as "Regulation Six"). This regulation clearly stipulates the reporting methods and content for serious adverse reactions arising from the implementation of regenerative medicine technologies, as well as the central competent authority's investigation and supervision of serious adverse reactions, aiming to implement safety monitoring mechanisms and ensure patient safety. A summary of key points is as follows:

(1) Definition of Serious Adverse Reactions

Serious adverse reactions refer to situations where the execution of regenerative technologies results in death, life-threatening conditions, hospitalization, permanent disability, prolonged hospital stays, potential permanent harm, or congenital malformations (Article 2 of the Regulation Six).

(2) Reporting Period and Method for Serious Adverse Reactions

When a serious adverse reaction occurs in connection with the implementation of regenerative medicine technologies, the medical institution must report the incident to the central competent authority by completing and submitting a report form via the designated online system within seven days from the day following its awareness of the incident. If the adverse reactions involve regenerative medicinal products designated by the central competent authority, the reporting should follow the Regulations for Reporting Serious Adverse Reactions of Medicaments (Article 3 of the Regulation Six).

(3) Actions by the Central Competent Authority Upon Receiving a Report

If the central competent authority finds the report content unclear or incomplete, it may require the medical institution to rectify the report within a specified period and implement appropriate management and supervision measures. Medical institutions must provide relevant documents and data upon request and are not allowed to evade, obstruct, or refuse such requests (Articles 5 and 6 of the Regulation Six).

Medical institutions that fail to report serious adverse reactions involving designated regenerative medicinal products or technologies will face fines ranging from NT$50,000 to NT$500,000. Repeated offenses will incur repeated fines until compliance is achieved (Article 32(12) of the Regenerative Medicine Act).