Regulations on Informed Consent of Those Who Provide Their Tissues or Cells for Regenerative Medicinal Products
2025-12-01
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Article 1
The Regulations are prescribed in accordance with Paragraph 2 of Article 13 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).
Article 2
Before 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.
When 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.
Manufacturers shall not obtain the consent of the authorized consenting party through coercion, enticement, or any other improper means.
When 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.
Manufacturers shall not obtain the consent of the authorized consenting party through coercion, enticement, or any other improper means.
Article 3
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.
Article 4
If 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.
For 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.
For 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.
Article 5
The consent form specified in Article 2 shall be retained by the manufacturer for at least thirty years from the date of receipt.
Article 6
The Regulations shall come into effect on the day when the Act becomes effective.