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Regulations on Informed Consent of Those Who Provide Their Tissues or Cells for Regenerative Medicinal Products
1.中華民國一百十四年十二月一日衛生福利部衛授食字第 1141400977 號 令訂定發布全文 6 條；並自再生醫療製劑條例施行 中華民國一百十四年十二月三十日行政院院臺衛字第 1141035478 號令 發布「再生醫療製劑條例」定自一百十五年一月一日施行
資料來源：全國法規資料庫（ChOrder.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
The Regulations are prescribed in accordance with Paragraph 2 of Article 13 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).
1Before obtaining human tissues or cells domestically, manufacturers shall inform the provider or their designated representatives, as specified in Article 12 of the Act (hereinafter referred to as “person with consent authority”), of all matters required under Paragraph 1 of Article 13 and any other pertinent information. This disclosure may be provided in writing or verbally, but all information shared must be clearly documented within the formal consent form.
2When manufacturers execute the informed consent specified in the preceding paragraph, it may be performed by their employees or agents, and the person providing the information shall first sign and date the form, which shall then be presented to the person with consent authority to sign and date. When the manufacturer receives the consent form, the person receiving it shall sign and indicate the date of receipt.
3Manufacturers shall not obtain the consent of the authorized consenting party through coercion, enticement, or any other improper means.
When foreign manufacturers authorize domestic regenerative medicinal product distributors to obtain tissues or cells from provider domestically and subsequently export them abroad for manufacturing, the provisions of the preceding article shall apply mutatis mutandis regarding the obtaining of consent forms.
1If information that may affect the person with consent authority’s willingness but was not included in the consent form specified in Article 2 is subsequently discovered, the manufacturer shall immediately cease using the original consent form, revise its content, and re-obtain consent from the person with consent authority before obtaining tissues or cells.
2For tissues or cells already obtained by the manufacturer before the original consent form ceased to be applicable, the rights and obligations between the tissue or cell provider and the manufacturer may be handled in accordance with the content related to Subparagraph 9 of Paragraph 1 of Article 13 of the Act, as stated in the original consent form, or through a separate agreement.
The consent form specified in Article 2 shall be retained by the manufacturer for at least thirty years from the date of receipt.
The Regulations shall come into effect on the day when the Act becomes effective.