June 2025
Series Articles of the Regenerative Medicine Dual Legislation (6) – Clarifying Donor Eligibility and Fee Standards: Supporting Regulations Under the Regenerative Medicine Products Act Released (Taiwan)
On June 4, 2024, 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”), thereby establishing the legal framework for the development of regenerative medicine in Taiwan. The Ministry of Health and Welfare (“MOHW”) had previously released the draft sub-regulations under the Regenerative Medicinal Products Act for public consultation.
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In May 2025, the MOHW further promulgated two additional draft sub-regulations related to regenerative medicinal products: (1) Fee-charging Standards for Regenerative Medicinal Products, and (2) Regulations on the Eligibility Determination of Human Cell and Tissue Donors for Regenerative Medicinal Products. This article provides a focused overview of the key points in the above-mentioned draft regulations.
I. Draft of the “Fee-charging Standards for Regenerative Medicinal Products” (Public Comment Period until July 21, 2025)
Pursuant to Article 8, Paragraph 3 of the Regenerative Medicinal Products Act and Article 10 of the Charges and Fees Act, the MOHW has formulated the draft Fee-charging Standards for Regenerative Medicinal Products (the “Fee-charging Standards”), with the aim of establishing the legal basis and procedures for collecting fees related to administrative matters concerning regenerative medicinal products. The draft consists of thirteen articles, with key provisions as follows:
1. Fees for Drug Registration and Licensing-Related Applications
These include fees for drug registration, clinical trial applications (Articles 2 and 3 of the Fee-charging Standards), change of drug license and approval conditions holder, change of originally registered particulars (Article 4 of the Fee-charging Standards), amendments to export-only licenses (Article 5 of the Fee-charging Standards), license extensions (Article 6 of the Fee-charging Standards), and reissuance of licenses, package inserts, and labeling documents (Article 7 of the Fee-charging Standards).
2. Fees for Special-Purpose Applications
These cover applications related to special review mechanisms, recognition of life-threatening or severely debilitating diseases, sample importation, import authorization, certificate issuance, consultation meetings, corrections to registration information (Article 10 of the Fee-charging Standards), and applications for advertising the recruitment of tissue or cell donors (Article 11 of the Fee-charging Standards).
3. Article 13 specifies the effective date of the regulations to ensure clarity and enforceability in the implementation of the new regime.
II. Draft of the “Regulations on the Eligibility Determination of Human Cell and Tissue Donors for Regenerative Medicinal Products” (Public Comment Period until July 25, 2025)
Pursuant to Article 11, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW has issued the draft Regulations on the Eligibility Determination of Human Cell and Tissue Donors for Regenerative Medicinal Products (the “Eligibility Regulations”). The purpose of the Eligibility Regulations is to establish clear criteria and operational standards for determining the suitability of tissue and cell donors. These regulations provide a uniform framework for screening, testing, and evaluating donors, which must be followed by manufacturers or importers of regenerative medicinal products (collectively referred to as “pharmaceutical firms”) during the manufacturing or importation.
The Eligibility Regulations serve to strengthen the risk control mechanisms for human tissue- or cell-derived materials, ensuring the quality and safety of regenerative medicinal products, and establishing a safe, traceable, and compliant regulatory framework. Key provisions of the draft Eligibility Regulations include:
1. Suitability Determination Obligations and Procedures for Pharmaceutical Firms
Pharmaceutical firms must carry out donor screening, testing, and suitability determinations, which may also be delegated to a qualified third party. Standard operating procedures (SOPs) must be established for these processes, and the final suitability determination must be conducted by a physician with specified qualifications (Article 3 of the Eligibility Regulations).
2. Disqualification Criteria and Exceptions
Donors found, through screening or testing, to be infected with certain diseases (e.g., hepatitis B or C) or to have engaged in specified high-risk behaviors (e.g., non-medical injection drug use) may not be deemed suitable.
However, in cases involving urgent medical need for another individual or when the intended recipient is a first- or second-degree blood relative, the tissues or cells obtained from such a donor may be exempted from the above suitability determination restrictions (Articles 4 and 5 of the Eligibility Regulations).
3. Special Provisions for Neonatal and Autologous Use Donors
Where the tissue or cells are sourced from a neonate less than one month old, both the neonate and the biological mother must be screened, and the mother must be tested. If a sample from the mother cannot be obtained, the donor may not be deemed suitable.
For autologous use, although a formal suitability determination is not required, screening and testing must still be conducted, and the product must be labeled “For Autologous Use Only” (Articles 6 and 7 of the Eligibility Regulations).
4. Timeframe for Sample Collection
Biological samples for testing must be collected either at the time of tissue or cell retrieval, or within 7 days before or after such retrieval (Article 8 of the Eligibility Regulations).
5. Contents and Retention Period of Suitability Reports
A donor suitability determination report must be completed by the pharmaceutical firm or its delegate and retained by the pharmaceutical firm for at least 30 years after the end of the product’s storage period (Articles 9 and 10 of the Eligibility Regulations).
Pursuant to Article 21, Subparagraph 4 of the Regenerative Medicinal Products Act, a pharmaceutical firm that fails to ensure donor suitability and unlawfully manufactures or imports regenerative medicinal products may be subject to a fine ranging from NT$30,000 to NT$2 million, imposed by the competent municipal or county (city) authority.
[1] For other promulgated sub-regulations under the Act on the Regenerative Medicinal Products Act, please refer to the LTP March 2025 article, “Series Articles of the Regenerative Medicine Dual Legislation (4) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicinal Products Act (Taiwan).”
I. Draft of the “Fee-charging Standards for Regenerative Medicinal Products” (Public Comment Period until July 21, 2025)
Pursuant to Article 8, Paragraph 3 of the Regenerative Medicinal Products Act and Article 10 of the Charges and Fees Act, the MOHW has formulated the draft Fee-charging Standards for Regenerative Medicinal Products (the “Fee-charging Standards”), with the aim of establishing the legal basis and procedures for collecting fees related to administrative matters concerning regenerative medicinal products. The draft consists of thirteen articles, with key provisions as follows:
1. Fees for Drug Registration and Licensing-Related Applications
These include fees for drug registration, clinical trial applications (Articles 2 and 3 of the Fee-charging Standards), change of drug license and approval conditions holder, change of originally registered particulars (Article 4 of the Fee-charging Standards), amendments to export-only licenses (Article 5 of the Fee-charging Standards), license extensions (Article 6 of the Fee-charging Standards), and reissuance of licenses, package inserts, and labeling documents (Article 7 of the Fee-charging Standards).
2. Fees for Special-Purpose Applications
These cover applications related to special review mechanisms, recognition of life-threatening or severely debilitating diseases, sample importation, import authorization, certificate issuance, consultation meetings, corrections to registration information (Article 10 of the Fee-charging Standards), and applications for advertising the recruitment of tissue or cell donors (Article 11 of the Fee-charging Standards).
3. Article 13 specifies the effective date of the regulations to ensure clarity and enforceability in the implementation of the new regime.
II. Draft of the “Regulations on the Eligibility Determination of Human Cell and Tissue Donors for Regenerative Medicinal Products” (Public Comment Period until July 25, 2025)
Pursuant to Article 11, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW has issued the draft Regulations on the Eligibility Determination of Human Cell and Tissue Donors for Regenerative Medicinal Products (the “Eligibility Regulations”). The purpose of the Eligibility Regulations is to establish clear criteria and operational standards for determining the suitability of tissue and cell donors. These regulations provide a uniform framework for screening, testing, and evaluating donors, which must be followed by manufacturers or importers of regenerative medicinal products (collectively referred to as “pharmaceutical firms”) during the manufacturing or importation.
The Eligibility Regulations serve to strengthen the risk control mechanisms for human tissue- or cell-derived materials, ensuring the quality and safety of regenerative medicinal products, and establishing a safe, traceable, and compliant regulatory framework. Key provisions of the draft Eligibility Regulations include:
1. Suitability Determination Obligations and Procedures for Pharmaceutical Firms
Pharmaceutical firms must carry out donor screening, testing, and suitability determinations, which may also be delegated to a qualified third party. Standard operating procedures (SOPs) must be established for these processes, and the final suitability determination must be conducted by a physician with specified qualifications (Article 3 of the Eligibility Regulations).
2. Disqualification Criteria and Exceptions
Donors found, through screening or testing, to be infected with certain diseases (e.g., hepatitis B or C) or to have engaged in specified high-risk behaviors (e.g., non-medical injection drug use) may not be deemed suitable.
However, in cases involving urgent medical need for another individual or when the intended recipient is a first- or second-degree blood relative, the tissues or cells obtained from such a donor may be exempted from the above suitability determination restrictions (Articles 4 and 5 of the Eligibility Regulations).
3. Special Provisions for Neonatal and Autologous Use Donors
Where the tissue or cells are sourced from a neonate less than one month old, both the neonate and the biological mother must be screened, and the mother must be tested. If a sample from the mother cannot be obtained, the donor may not be deemed suitable.
For autologous use, although a formal suitability determination is not required, screening and testing must still be conducted, and the product must be labeled “For Autologous Use Only” (Articles 6 and 7 of the Eligibility Regulations).
4. Timeframe for Sample Collection
Biological samples for testing must be collected either at the time of tissue or cell retrieval, or within 7 days before or after such retrieval (Article 8 of the Eligibility Regulations).
5. Contents and Retention Period of Suitability Reports
A donor suitability determination report must be completed by the pharmaceutical firm or its delegate and retained by the pharmaceutical firm for at least 30 years after the end of the product’s storage period (Articles 9 and 10 of the Eligibility Regulations).
Pursuant to Article 21, Subparagraph 4 of the Regenerative Medicinal Products Act, a pharmaceutical firm that fails to ensure donor suitability and unlawfully manufactures or imports regenerative medicinal products may be subject to a fine ranging from NT$30,000 to NT$2 million, imposed by the competent municipal or county (city) authority.
[1] For other promulgated sub-regulations under the Act on the Regenerative Medicinal Products Act, please refer to the LTP March 2025 article, “Series Articles of the Regenerative Medicine Dual Legislation (4) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicinal Products Act (Taiwan).”
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