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Chapter Law Content

Title: Regenerative Medicine Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 5 Supervision and Relief
Article 21
Except 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.
Advertisements 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.
Article 22
Recruitment 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.
Prior 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.
If 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.
The 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.
The regenerative technique under Article 8, Paragraph 1, Subparagraph 1 shall not be advertised.
Article 23
Broadcasters 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.
Broadcasters 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.
When the competent authority requests the provision of the documents and data under the preceding paragraph, the broadcaster shall not evade, obstruct, or refuse.
Article 24
Medical 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.
The 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.
The 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.
Article 25
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.
Article 26
If 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:
1. 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.
2. The number or severity of adverse events is abnormally high.
3. Failure to report as required by the front portion of the previous paragraph.
4. Failure to comply with the provisions of Article 14, Paragraph 4, when performing cell manipulation.
5. Other circumstances that seriously affect the rights and safety of patients.
If 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.
Medical care institutions that have terminated the regenerative medicine implementation under the preceding two paragraphs shall submit a subsequent handling plan to the central competent authority for approval within the deadline prescribed by the central competent authority, including the content of tissues, cells, specimens, and implementation records. After approval, it shall be implemented according to the subsequent handling plan.
Article 27
Medical 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.
The relief measures under the preceding paragraph may be implemented by purchasing relevant liability insurance.