June 2025
Series Articles of the Regenerative Medicine Dual Legislation (7) – Draft Regulations on Cell Processing and Cell Bank Licensing Announced: Regenerative Medicine Act Taking Shape (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”). The Ministry of Health and Welfare (“MOHW”) has since released draft sub-regulations under the Regenerative Medicine Act for public consultation.
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In May 2025, the MOHW issued two additional draft sub-regulations pursuant to the Regenerative Medicine Act, namely: (1) Regenerative Medicine Cell Operation Management Regulations, and (2) Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations. This article provides a focused overview of the key provisions of the above-mentioned draft regulations.
I. Draft of the “Regenerative Medicine Cell Operation Management Regulations” (Public Comment Period until July 7, 2025)
The draft Regenerative Medicine Cell Operation Management Regulations (“Cell Operation Management Regulations”) were formulated by the MOHW pursuant to Article 14, Paragraph 4 of the Regenerative Medicine Act. This draft regulation aims to establish a regulatory framework to ensure the quality and safety of procedures involving the collection, processing, storage, and importation of human cells. Given the complexity and inherent risks of cell processing, including contamination, quality variations, and cross-contamination, this draft introduces a systematic framework for the oversight of cell processing institutions 2 . Key provisions are summarized as follows:
1. Quality Standards for Cell Processing
Cell processing institutions must conduct operations in accordance with the Good Tissue Practice as announced by the MOHW and must establish standard operating procedures (SOPs) for all stages of cell transport and distribution (Article 2 of the Cell Operation Management Regulations).
2. Review and Inspection Mechanisms
To obtain a cell processing permit, applicants must submit supporting documentation and pay the prescribed fees. The MOHW will conduct on-site inspections during which applicants must demonstrate their processing operations in practice. If deficiencies are found, an improvement report must be submitted, and the MOHW may conduct a follow-up inspection as necessary. A permit will be issued upon successful completion of the inspection process. Furthermore, the MOHW may conduct both scheduled and unscheduled inspections without prior notice (Articles 3 to 5 of the Cell Operation Management Regulations).
3. Permit Contents and Change Management
The cell processing permit must specify the name and address of the cell processing institution and facility, the operation area, items of operation, and the validity period. If there are any changes to the required information listed on the permit, an application for modification must be submitted. However, if the address of the processing facility involves a substantial relocation, a new application must be filed (Articles 7 and 8 of the Cell Operation Management Regulations).
4. Permit Validity and Extension Procedures
A cell processing permit is valid for three years. Requests for extension must be submitted between six to eight months prior to expiration. Each extension, once granted, will be valid for an additional three years, and the same application and inspection procedures under Articles 3 and 4 of the Cell Operation Management Regulations apply (Article 9 of the Cell Operation Management Regulations).
5. Sanctions for Serious Violations
If a cell processing institution violates the procedures, controls, or distribution standards, or Article 8, Paragraph 4 of the Cell Operation Management Regulations, which prohibits unauthorized changes made without prior approval, and such violations pose a serious threat to patient life or health, the MOHW may revoke all or part of the institution’s permit (Article 10 of the Cell Operation Management Regulations).
Penalties for Noncompliance with Cell Processing Requirements
The Regenerative Medicine Act stipulates clear penalties and administrative sanctions for conducting cell processing without approval, violations related to the qualifications and training of cell processing personnel, or breaches of operational standards. These include, but are not limited to, fines ranging from NT$50,000 to NT$2,000,000. If the violations are not rectified within the specified period, repeated fines may be imposed until compliance is achieved (Articles 28 to 32 of the Regenerative Medicine Act).
If a violation by a cell processing institution affects patient rights or safety, the MOHW may order the suspension or termination of all or part of the regenerative medical procedures and make a public announcement (Article 26, Paragraph 1, Subparagraph 4 of the Regenerative Medicine Act).
II. Draft of the “Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations” (Public Notice Period Until July 7, 2025)
Pursuant to Article 18, Paragraph 2 of the Regenerative Medicine Act, the MOHW has formulated the Draft Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations (hereinafter referred to as the “Regulations II”). The Cell Bank Management Regulations are intended to clearly set forth the conditions for the establishment and operational management of cell banks, with the aim of ensuring the viability and quality of human tissues, cells, and their derivatives. Key provisions are summarized as follows:
1. Eligibility Requirements and Facility Standards
Only medical care institutions or regenerative medicine biotechnology and pharmaceutical companies that have obtained a Cell Processing License pursuant to Article 14, Paragraph 2 of the Regenerative Medicine Act are eligible to apply for the establishment of a regenerative medicine cell bank. The cell bank must appoint a Medical Director and a Quality Director who meet the qualifications, and comply with the requirements on facilities, equipment, personnel, and quality management as stipulated in the Good Tissue Practice (GTP) guidelines (Articles 2–5 of the Cell Bank Management Regulations).
2. Scope of Storage and Document Retention Period
Cell banks may store human tissues, cells, or their derivatives. Required documentation includes the donor's consent form, donor suitability certification, examination and processing reports, and storage records. All relevant documents must be retained for at least 30 years from the date of acquisition or creation (Article 6 of the Cell Bank Management Regulations).
3. Licensing Review and On-Site Inspections
Applications for cell bank licenses must include an application form, supporting documentation, and the prescribed fee, and must be submitted to the MOHW. On-site inspections will be conducted. The MOHW may also carry out follow-up inspections as necessary. Upon successful completion of the inspection(s), the MOHW shall issue a license for the establishment of the cell bank. The MOHW may conduct regular or unannounced inspections without prior notice (Articles 7–9 of the Cell Bank Management Regulations).
4. License Information and Change Procedures
A cell bank license must specify information such as the license holder, names of the Medical and Quality Directors, the name and address of the cell bank, the designated storage area, types of materials stored, and the license validity period. Formal changes (e.g., house number adjustment) require notification and registration. Substantive changes (e.g., relocation, changes in storage area or items) require reapplication for the license or re-inspection under the applicable regulatory procedures. No expansion of operations shall be allowed prior to MOHW approval (Articles 11–12 of the Cell Bank Management Regulations).
5. License Validity and Extension
The initial license is valid for three years. To apply for an extension, the licensee must submit a request between six and eight months before the expiration date. Each extension may be granted for up to three years. The procedures under Articles 7 and 8 of the Cell Bank Management Regulations apply mutatis mutandis (Article 13 of the Cell Bank Management Regulations).
6. Use Restrictions and Fee Disclosure
Cell banks may be used only for: execution of regenerative medicine technologies, R&D and manufacturing of regenerative medicine products, academic research projects conducted by government agencies, medical care institutions, or universities. Medical care institutions establishing cell banks may not accept external commissions for the collection, storage, processing, provision, or manipulation of human tissues, cells, or their derivatives, except for self-use or authorized delegation. If any fees are charged, the fee schedule, payment, and refund policies must be clearly stated and publicly disclosed (Articles 14–16 of the Cell Bank Management Regulations).
7. Benefit-Sharing from Commercial Use
Cell banks established by regenerative medicine biotech companies that derive commercial benefits from the R&D or manufacturing of regenerative medical products must implement a benefit-sharing mechanism. If a specific donor group can be identified, benefits shall be returned to that group. If not, the benefits shall be distributed to the general public (Article 18 of the Cell Bank Management Regulations).
8. Violations and Prohibitions
If a cell bank is found to be in serious violation of requirements concerning facilities, equipment, quality control, storage scope, license changes, fee collection, refunds, or benefit-sharing, and such violations pose risks to patient life, health, or bodily integrity, the MOHW may revoke all or part of the granted license. Furthermore, any cell bank not established in accordance with the Cell Bank Management Regulations is prohibited from engaging in or promoting cell banking activities (Articles 19 & 21 of the Cell Bank Management Regulations).
Sanctions for Violations Related to Cell Bank Establishment and Operation
The Regenerative Medicine Act stipulates clear penalties for unauthorized establishment of cell banks, failure to ensure donor suitability, violations of storage and management regulations, or non-compliance with personnel qualification requirements. These penalties include, but are not limited to, fines ranging from NT$200,000 to NT$2,000,000, along with an order to make corrections within a specified period. If the violations are not rectified within the deadline, repeat penalties will be imposed until compliance is achieved (Articles 28, 29, and 31 of the Regenerative Medicine Act).
[1] For other promulgated sub-regulations under the Act on the Regenerative Medicine Act, please refer to the LTP April 2025 article, “ Series Articles of the Regenerative Medicine Dual Legislation (5) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicine Act (Taiwan). ”
[2] Including medical care institutions that perform cell processing, as well as regenerative medicine biotechnology and pharmaceutical companies or medical care institutions entrusted by them, as specified in Article 14, Paragraph 1 of the Regenerative Medicine Act.
I. Draft of the “Regenerative Medicine Cell Operation Management Regulations” (Public Comment Period until July 7, 2025)
The draft Regenerative Medicine Cell Operation Management Regulations (“Cell Operation Management Regulations”) were formulated by the MOHW pursuant to Article 14, Paragraph 4 of the Regenerative Medicine Act. This draft regulation aims to establish a regulatory framework to ensure the quality and safety of procedures involving the collection, processing, storage, and importation of human cells. Given the complexity and inherent risks of cell processing, including contamination, quality variations, and cross-contamination, this draft introduces a systematic framework for the oversight of cell processing institutions 2 . Key provisions are summarized as follows:
1. Quality Standards for Cell Processing
Cell processing institutions must conduct operations in accordance with the Good Tissue Practice as announced by the MOHW and must establish standard operating procedures (SOPs) for all stages of cell transport and distribution (Article 2 of the Cell Operation Management Regulations).
2. Review and Inspection Mechanisms
To obtain a cell processing permit, applicants must submit supporting documentation and pay the prescribed fees. The MOHW will conduct on-site inspections during which applicants must demonstrate their processing operations in practice. If deficiencies are found, an improvement report must be submitted, and the MOHW may conduct a follow-up inspection as necessary. A permit will be issued upon successful completion of the inspection process. Furthermore, the MOHW may conduct both scheduled and unscheduled inspections without prior notice (Articles 3 to 5 of the Cell Operation Management Regulations).
3. Permit Contents and Change Management
The cell processing permit must specify the name and address of the cell processing institution and facility, the operation area, items of operation, and the validity period. If there are any changes to the required information listed on the permit, an application for modification must be submitted. However, if the address of the processing facility involves a substantial relocation, a new application must be filed (Articles 7 and 8 of the Cell Operation Management Regulations).
4. Permit Validity and Extension Procedures
A cell processing permit is valid for three years. Requests for extension must be submitted between six to eight months prior to expiration. Each extension, once granted, will be valid for an additional three years, and the same application and inspection procedures under Articles 3 and 4 of the Cell Operation Management Regulations apply (Article 9 of the Cell Operation Management Regulations).
5. Sanctions for Serious Violations
If a cell processing institution violates the procedures, controls, or distribution standards, or Article 8, Paragraph 4 of the Cell Operation Management Regulations, which prohibits unauthorized changes made without prior approval, and such violations pose a serious threat to patient life or health, the MOHW may revoke all or part of the institution’s permit (Article 10 of the Cell Operation Management Regulations).
Penalties for Noncompliance with Cell Processing Requirements
The Regenerative Medicine Act stipulates clear penalties and administrative sanctions for conducting cell processing without approval, violations related to the qualifications and training of cell processing personnel, or breaches of operational standards. These include, but are not limited to, fines ranging from NT$50,000 to NT$2,000,000. If the violations are not rectified within the specified period, repeated fines may be imposed until compliance is achieved (Articles 28 to 32 of the Regenerative Medicine Act).
If a violation by a cell processing institution affects patient rights or safety, the MOHW may order the suspension or termination of all or part of the regenerative medical procedures and make a public announcement (Article 26, Paragraph 1, Subparagraph 4 of the Regenerative Medicine Act).
II. Draft of the “Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations” (Public Notice Period Until July 7, 2025)
Pursuant to Article 18, Paragraph 2 of the Regenerative Medicine Act, the MOHW has formulated the Draft Regenerative Medicine Cell Bank Establishment and Licensing Management Regulations (hereinafter referred to as the “Regulations II”). The Cell Bank Management Regulations are intended to clearly set forth the conditions for the establishment and operational management of cell banks, with the aim of ensuring the viability and quality of human tissues, cells, and their derivatives. Key provisions are summarized as follows:
1. Eligibility Requirements and Facility Standards
Only medical care institutions or regenerative medicine biotechnology and pharmaceutical companies that have obtained a Cell Processing License pursuant to Article 14, Paragraph 2 of the Regenerative Medicine Act are eligible to apply for the establishment of a regenerative medicine cell bank. The cell bank must appoint a Medical Director and a Quality Director who meet the qualifications, and comply with the requirements on facilities, equipment, personnel, and quality management as stipulated in the Good Tissue Practice (GTP) guidelines (Articles 2–5 of the Cell Bank Management Regulations).
2. Scope of Storage and Document Retention Period
Cell banks may store human tissues, cells, or their derivatives. Required documentation includes the donor's consent form, donor suitability certification, examination and processing reports, and storage records. All relevant documents must be retained for at least 30 years from the date of acquisition or creation (Article 6 of the Cell Bank Management Regulations).
3. Licensing Review and On-Site Inspections
Applications for cell bank licenses must include an application form, supporting documentation, and the prescribed fee, and must be submitted to the MOHW. On-site inspections will be conducted. The MOHW may also carry out follow-up inspections as necessary. Upon successful completion of the inspection(s), the MOHW shall issue a license for the establishment of the cell bank. The MOHW may conduct regular or unannounced inspections without prior notice (Articles 7–9 of the Cell Bank Management Regulations).
4. License Information and Change Procedures
A cell bank license must specify information such as the license holder, names of the Medical and Quality Directors, the name and address of the cell bank, the designated storage area, types of materials stored, and the license validity period. Formal changes (e.g., house number adjustment) require notification and registration. Substantive changes (e.g., relocation, changes in storage area or items) require reapplication for the license or re-inspection under the applicable regulatory procedures. No expansion of operations shall be allowed prior to MOHW approval (Articles 11–12 of the Cell Bank Management Regulations).
5. License Validity and Extension
The initial license is valid for three years. To apply for an extension, the licensee must submit a request between six and eight months before the expiration date. Each extension may be granted for up to three years. The procedures under Articles 7 and 8 of the Cell Bank Management Regulations apply mutatis mutandis (Article 13 of the Cell Bank Management Regulations).
6. Use Restrictions and Fee Disclosure
Cell banks may be used only for: execution of regenerative medicine technologies, R&D and manufacturing of regenerative medicine products, academic research projects conducted by government agencies, medical care institutions, or universities. Medical care institutions establishing cell banks may not accept external commissions for the collection, storage, processing, provision, or manipulation of human tissues, cells, or their derivatives, except for self-use or authorized delegation. If any fees are charged, the fee schedule, payment, and refund policies must be clearly stated and publicly disclosed (Articles 14–16 of the Cell Bank Management Regulations).
7. Benefit-Sharing from Commercial Use
Cell banks established by regenerative medicine biotech companies that derive commercial benefits from the R&D or manufacturing of regenerative medical products must implement a benefit-sharing mechanism. If a specific donor group can be identified, benefits shall be returned to that group. If not, the benefits shall be distributed to the general public (Article 18 of the Cell Bank Management Regulations).
8. Violations and Prohibitions
If a cell bank is found to be in serious violation of requirements concerning facilities, equipment, quality control, storage scope, license changes, fee collection, refunds, or benefit-sharing, and such violations pose risks to patient life, health, or bodily integrity, the MOHW may revoke all or part of the granted license. Furthermore, any cell bank not established in accordance with the Cell Bank Management Regulations is prohibited from engaging in or promoting cell banking activities (Articles 19 & 21 of the Cell Bank Management Regulations).
Sanctions for Violations Related to Cell Bank Establishment and Operation
The Regenerative Medicine Act stipulates clear penalties for unauthorized establishment of cell banks, failure to ensure donor suitability, violations of storage and management regulations, or non-compliance with personnel qualification requirements. These penalties include, but are not limited to, fines ranging from NT$200,000 to NT$2,000,000, along with an order to make corrections within a specified period. If the violations are not rectified within the deadline, repeat penalties will be imposed until compliance is achieved (Articles 28, 29, and 31 of the Regenerative Medicine Act).
[1] For other promulgated sub-regulations under the Act on the Regenerative Medicine Act, please refer to the LTP April 2025 article, “ Series Articles of the Regenerative Medicine Dual Legislation (5) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicine Act (Taiwan). ”
[2] Including medical care institutions that perform cell processing, as well as regenerative medicine biotechnology and pharmaceutical companies or medical care institutions entrusted by them, as specified in Article 14, Paragraph 1 of the Regenerative Medicine Act.
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Clarifying Donor Eligibility and Fee Standards: Supporting Regulations Under the Regenerative Medicine Products Act Released (Taiwan)
