March 2025
Series Articles of the Regenerative Medicine Dual Legislation (4) – Draft Announcement of Certain Subsidiary Regulations Under the Regenerative Medicinal Products Act (Taiwan)
The Legislative Yuan of Taiwan completed the third reading and passed the "Regenerative Medicine Act" and the "Regenerative Medicinal Products Act" (collectively referred to as the "Regenerative Medicine Dual Legislation") on June 4, 2024. These laws were promulgated by the President on June 19, 2024, and will officially take effect once the Executive Yuan establishes an implementation date.
The Ministry of Health and Welfare (hereinafter referred to as "MOHW") has recently issued draft announcements for several subsidiary regulations under the "Regenerative Medicinal Products Act". The related draft measures address matters including safety monitoring and management of regenerative medicine, preservation of data on the supply sources and flow of regenerative medicine products, matters to be followed in recruitment advertisements for tissue and cell providers of regenerative medicine, and informed consent for tissue and cell providers of regenerative medicine.
I. Draft of the "Regulations for the Management of Regenerative Medicine Safety Surveillance" (Announced on August 19, 2024)
According to Article 17, Paragraph 3 of the "Regenerative Medicinal Products Act", the MOHW is responsible for formulating the "Regenerative Medicine Product Safety Surveillance and Management Regulations" (hereinafter referred to as "Regulation One") to ensure the safety surveillance and management of regenerative medicinal products.
Regulation One primarily stipulates the submission methods, deadlines, content, and format for safety surveillance data and reports, as well as the limitations and maintenance requirements for data collection. Additionally, Regulation One clearly defines the surveillance period, assessment standards, and other compliance requirements to ensure the safety and effectiveness of regenerative medicine products. The key points are summarized as follows:
(1) Drug Safety Surveillance Plan
Pharmaceutical companies must establish a Drug Safety Surveillance Plan that includes monitoring procedures, sources of drug safety information, evaluation and analysis of information, internal personnel responsibilities, and training measures (Article 4 of the Regulation One).
(2) Adverse Reaction Reporting
Pharmaceutical companies must report to the online system established by the central competent authority within three days of becoming aware of any unexpected or severe adverse reactions, and cases where a drug has been suspended or withdrawn in the top ten leading pharmaceutical countries due to adverse reactions (Article 5 of the Regulation One).
(3) Periodic Safety Reports
During the validity period of a regenerative medicine product license or conditional approval, pharmaceutical companies must continuously collect safety data and submit periodic safety reports to the competent authority within the specified timeframe (Article 7 of the Regulation One).
(4) Implementation of Risk Assessment and Control Plans
The central competent authority may designate specific types or ingredients of regenerative medicine products, or, prior to the issuance of permits or conditional permits for regenerative medicinal preparations, pharmaceutical companies may be required to establish risk assessment and control plans (Article 8 of the Regulation One).
Failure by the holder of a drug license or conditional approval to comply with the approved or approved safety surveillance plan, failure by medical institutions to provide safety surveillance data, or violations of the reporting content, submission deadlines, or surveillance periods specified in Regulation One may result in fines ranging from NT$30,000 to NT$2,000,000 (Article 21, Paragraphs 10 and 11 of the Regenerative Medicinal Products Act).
II. Draft of the "Regulations of Regenerative Medicinal Product Traceability and Documentation" (Announced on January 15, 2025)
Pursuant to Article 18, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW is responsible for establishing the Regulations of Regenerative Medicinal Product Traceability and Documentation (hereinafter referred to as "Regulation Two") to regulate the management of the supply sources and distribution of regenerative medicine products by medical institutions and pharmaceutical companies.
Regulation Two aims to ensure that the competent authority can track the long-term distribution of regenerative medicinal products, enhance drug safety supervision, and protect both patient medication safety and personal data privacy. The regulation outlines the scope, methods, retention periods, and audit mechanisms for data preservation, ensuring supply chain transparency, mitigating potential risks, and maintaining medical quality and patient rights. The key provisions are summarized as follows:
(1) Scope of Data Preservation for the Supply Source and Distribution of Regenerative Medicine Products
Holders of a drug license or conditional approval must maintain records of the supply sources and distribution of regenerative medicine products ( Article 2 of the Regulation Two); Distributors must maintain records of the supply sources and distribution of the regenerative medicine products they sell (Article 3 of the Regulation Two); Medical institutions must maintain records of the regenerative medicine products they utilize to ensure traceability and regulatory compliance (Article 4 of the Regulation Two).
(2) Data Retention Period
Pharmaceutical companies (including holders of a regenerative medicine product license or conditional approval, as well as distributors) must maintain records for at least 30 years after the expiration of the product's shelf life. Medical institutions must maintain records for at least 15 years from the date of their use (Article 5 of the Regulation Two).
(3) Data Submission and Audit
The competent authority may require pharmaceutical companies and medical institutions to provide supply sources and distribution data along with supporting documents. The competent authority may also conduct on-site inspections, and pharmaceutical companies and medical institutions must not evade, obstruct, or refuse these inspections (Article 6 of the Regulation Two).
Pharmaceutical companies or medical institutions that fail to preserve the required data or violate regulations regarding the scope, method, or retention period of data preservation may face fines ranging from NT$30,000 to NT$2,000,000, as imposed by the local competent authority (Article 21, Paragraphs 12 and 13 of the Regenerative Medicinal Products Act).
III. Draft of the Regulations of Regenerative Medicinal Tissue and Cell Provider Recruitment Advertisement (Announced on February 6, 2025)
Pursuant to Article 15, Paragraph 6 of the Regenerative Medicinal Products Act, the MOHW is responsible for formulating the Regulations of Regenerative Medicinal Tissue and Cell Provider Recruitment Advertisement (hereinafter referred to as "Regulation Three"), which provides more detailed provisions regarding the content, dissemination methods, and target audience of recruitment advertisements.
Regulation Three explicitly outlines the permissible and prohibited wording, language, images, and other content in advertisements. It also imposes restrictions on the methods and locations of dissemination to ensure that recruitment information is transparent and truthful, while preventing exaggeration or misleading claims. This regulation aims to protect the rights and autonomy of tissue and cell donors in their decision-making processes. The key provisions are summarized as follows:
(1) Application Requirements for Advertisement Dissemination
If an advertisement involves the recruitment of tissue or cell donors for regenerative medicinal products, the holder of a drug license or conditional approval must submit an application form to the central competent authority or its designated agency or legal entity for approval before dissemination (Article 2 of the Regulation Three).
(2) Content of Recruitment Advertisements
The content of recruitment advertisements must include information related to the collection of cells and tissues. Advertisements must not assert that they are harmless, exaggerate benefits, or use improper methods to induce individuals to donate tissue or cells. Additionally, they must not include false, misleading, or deceptive statements (Articles 3 and 4 of the Regulation Three).
(3) Methods and Locations for Advertisement Dissemination
To prevent recruitment targets from making impulsive, uninformed, or coerced decisions due to a lack of experience or legal capacity, advertisements must not be disseminated on high school campuses or lower educational institutions, on job-matching or part-time work recruitment websites, through interviews or news reports as a form of disguised promotion, or by using coercion, financial incentives, or other improper promotional methods (Article 5 of the Regulation Three).
(4) Validity Period of Approved Advertisements
Upon approval, a recruitment advertisement remains valid for 3 years. An extension may be requested; however, the application must be submitted at least 6 months before the expiration date. Each extension shall not exceed 3 years (Article 6 of the Regulation Three).
If a recruitment advertisement is disseminated without approval, modified without authorization, published in violation of the approved content, or continues to be disseminated after the revocation of approval, the responsible entity may face substantial fines. Furthermore, failure to retain or provide required data, or violations of advertisement location restrictions, may also constitute legal infractions. Pursuant to Article 20 of the Regenerative Medicinal Products Act, the central competent authority may impose a fine ranging from NT$30,000 to NT$2,000,000.
IV. Draft of the Regulations of Regenerative Medicinal Tissue and Cell Provider Consent (Announced on February 13, 2025)
Pursuant to Article 13, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW is responsible for formulating the Regulations of Regenerative Medicinal Tissue and Cell Provider Consent (hereinafter referred to as "Regulation Four"). This regulation establishes detailed provisions regarding the methods, procedures, and compliance requirements for obtaining informed consent from donors. It ensures that donors fully understand their rights and potential risks while safeguarding their autonomy in decision-making. The key provisions are summarized as follows:
(1) Procedures and Review of Informed Consent
When manufacturing regenerative medicine products using human tissues or cells obtained domestically, the manufacturer must inform the consent giver of the relevant regulations prior to obtaining their consent. The consent giver must sign and date the informed consent form. Additionally, the person explaining the information and receiving the consent form must also sign and date the document. The content of the informed consent form must be reviewed and approved by an ethics review committee. Manufacturers must not obtain consent through coercion, inducement, or any other improper means.
If an approved consent form is later discovered to lack critical information that could influence the decision of the consent giver, the use of the obtained tissues or cells must be suspended. The form must be revised and resubmitted to the ethics review committee for approval, and new consent must be obtained before proceeding with the collection (Articles 2 and 4 of the Regulation Four).
(2) Exportation for Overseas Manufacturing
If a regenerative medicinal products distributor obtains tissues or cells from domestic donors and subsequently exports them for overseas manufacturing, the same requirements for documentation and ethics review of informed consent shall apply (Article 3 of the Regulation Four).
(3) Retention of Consent Forms
A regenerative medicinal products manufacturer must retain informed consent forms for at least 30 years from the date of receipt (Article 5 of the Regulation Four).
The Ministry of Health and Welfare (hereinafter referred to as "MOHW") has recently issued draft announcements for several subsidiary regulations under the "Regenerative Medicinal Products Act". The related draft measures address matters including safety monitoring and management of regenerative medicine, preservation of data on the supply sources and flow of regenerative medicine products, matters to be followed in recruitment advertisements for tissue and cell providers of regenerative medicine, and informed consent for tissue and cell providers of regenerative medicine.
I. Draft of the "Regulations for the Management of Regenerative Medicine Safety Surveillance" (Announced on August 19, 2024)
According to Article 17, Paragraph 3 of the "Regenerative Medicinal Products Act", the MOHW is responsible for formulating the "Regenerative Medicine Product Safety Surveillance and Management Regulations" (hereinafter referred to as "Regulation One") to ensure the safety surveillance and management of regenerative medicinal products.
Regulation One primarily stipulates the submission methods, deadlines, content, and format for safety surveillance data and reports, as well as the limitations and maintenance requirements for data collection. Additionally, Regulation One clearly defines the surveillance period, assessment standards, and other compliance requirements to ensure the safety and effectiveness of regenerative medicine products. The key points are summarized as follows:
(1) Drug Safety Surveillance Plan
Pharmaceutical companies must establish a Drug Safety Surveillance Plan that includes monitoring procedures, sources of drug safety information, evaluation and analysis of information, internal personnel responsibilities, and training measures (Article 4 of the Regulation One).
(2) Adverse Reaction Reporting
Pharmaceutical companies must report to the online system established by the central competent authority within three days of becoming aware of any unexpected or severe adverse reactions, and cases where a drug has been suspended or withdrawn in the top ten leading pharmaceutical countries due to adverse reactions (Article 5 of the Regulation One).
(3) Periodic Safety Reports
During the validity period of a regenerative medicine product license or conditional approval, pharmaceutical companies must continuously collect safety data and submit periodic safety reports to the competent authority within the specified timeframe (Article 7 of the Regulation One).
(4) Implementation of Risk Assessment and Control Plans
The central competent authority may designate specific types or ingredients of regenerative medicine products, or, prior to the issuance of permits or conditional permits for regenerative medicinal preparations, pharmaceutical companies may be required to establish risk assessment and control plans (Article 8 of the Regulation One).
Failure by the holder of a drug license or conditional approval to comply with the approved or approved safety surveillance plan, failure by medical institutions to provide safety surveillance data, or violations of the reporting content, submission deadlines, or surveillance periods specified in Regulation One may result in fines ranging from NT$30,000 to NT$2,000,000 (Article 21, Paragraphs 10 and 11 of the Regenerative Medicinal Products Act).
II. Draft of the "Regulations of Regenerative Medicinal Product Traceability and Documentation" (Announced on January 15, 2025)
Pursuant to Article 18, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW is responsible for establishing the Regulations of Regenerative Medicinal Product Traceability and Documentation (hereinafter referred to as "Regulation Two") to regulate the management of the supply sources and distribution of regenerative medicine products by medical institutions and pharmaceutical companies.
Regulation Two aims to ensure that the competent authority can track the long-term distribution of regenerative medicinal products, enhance drug safety supervision, and protect both patient medication safety and personal data privacy. The regulation outlines the scope, methods, retention periods, and audit mechanisms for data preservation, ensuring supply chain transparency, mitigating potential risks, and maintaining medical quality and patient rights. The key provisions are summarized as follows:
(1) Scope of Data Preservation for the Supply Source and Distribution of Regenerative Medicine Products
Holders of a drug license or conditional approval must maintain records of the supply sources and distribution of regenerative medicine products ( Article 2 of the Regulation Two); Distributors must maintain records of the supply sources and distribution of the regenerative medicine products they sell (Article 3 of the Regulation Two); Medical institutions must maintain records of the regenerative medicine products they utilize to ensure traceability and regulatory compliance (Article 4 of the Regulation Two).
(2) Data Retention Period
Pharmaceutical companies (including holders of a regenerative medicine product license or conditional approval, as well as distributors) must maintain records for at least 30 years after the expiration of the product's shelf life. Medical institutions must maintain records for at least 15 years from the date of their use (Article 5 of the Regulation Two).
(3) Data Submission and Audit
The competent authority may require pharmaceutical companies and medical institutions to provide supply sources and distribution data along with supporting documents. The competent authority may also conduct on-site inspections, and pharmaceutical companies and medical institutions must not evade, obstruct, or refuse these inspections (Article 6 of the Regulation Two).
Pharmaceutical companies or medical institutions that fail to preserve the required data or violate regulations regarding the scope, method, or retention period of data preservation may face fines ranging from NT$30,000 to NT$2,000,000, as imposed by the local competent authority (Article 21, Paragraphs 12 and 13 of the Regenerative Medicinal Products Act).
III. Draft of the Regulations of Regenerative Medicinal Tissue and Cell Provider Recruitment Advertisement (Announced on February 6, 2025)
Pursuant to Article 15, Paragraph 6 of the Regenerative Medicinal Products Act, the MOHW is responsible for formulating the Regulations of Regenerative Medicinal Tissue and Cell Provider Recruitment Advertisement (hereinafter referred to as "Regulation Three"), which provides more detailed provisions regarding the content, dissemination methods, and target audience of recruitment advertisements.
Regulation Three explicitly outlines the permissible and prohibited wording, language, images, and other content in advertisements. It also imposes restrictions on the methods and locations of dissemination to ensure that recruitment information is transparent and truthful, while preventing exaggeration or misleading claims. This regulation aims to protect the rights and autonomy of tissue and cell donors in their decision-making processes. The key provisions are summarized as follows:
(1) Application Requirements for Advertisement Dissemination
If an advertisement involves the recruitment of tissue or cell donors for regenerative medicinal products, the holder of a drug license or conditional approval must submit an application form to the central competent authority or its designated agency or legal entity for approval before dissemination (Article 2 of the Regulation Three).
(2) Content of Recruitment Advertisements
The content of recruitment advertisements must include information related to the collection of cells and tissues. Advertisements must not assert that they are harmless, exaggerate benefits, or use improper methods to induce individuals to donate tissue or cells. Additionally, they must not include false, misleading, or deceptive statements (Articles 3 and 4 of the Regulation Three).
(3) Methods and Locations for Advertisement Dissemination
To prevent recruitment targets from making impulsive, uninformed, or coerced decisions due to a lack of experience or legal capacity, advertisements must not be disseminated on high school campuses or lower educational institutions, on job-matching or part-time work recruitment websites, through interviews or news reports as a form of disguised promotion, or by using coercion, financial incentives, or other improper promotional methods (Article 5 of the Regulation Three).
(4) Validity Period of Approved Advertisements
Upon approval, a recruitment advertisement remains valid for 3 years. An extension may be requested; however, the application must be submitted at least 6 months before the expiration date. Each extension shall not exceed 3 years (Article 6 of the Regulation Three).
If a recruitment advertisement is disseminated without approval, modified without authorization, published in violation of the approved content, or continues to be disseminated after the revocation of approval, the responsible entity may face substantial fines. Furthermore, failure to retain or provide required data, or violations of advertisement location restrictions, may also constitute legal infractions. Pursuant to Article 20 of the Regenerative Medicinal Products Act, the central competent authority may impose a fine ranging from NT$30,000 to NT$2,000,000.
IV. Draft of the Regulations of Regenerative Medicinal Tissue and Cell Provider Consent (Announced on February 13, 2025)
Pursuant to Article 13, Paragraph 2 of the Regenerative Medicinal Products Act, the MOHW is responsible for formulating the Regulations of Regenerative Medicinal Tissue and Cell Provider Consent (hereinafter referred to as "Regulation Four"). This regulation establishes detailed provisions regarding the methods, procedures, and compliance requirements for obtaining informed consent from donors. It ensures that donors fully understand their rights and potential risks while safeguarding their autonomy in decision-making. The key provisions are summarized as follows:
(1) Procedures and Review of Informed Consent
When manufacturing regenerative medicine products using human tissues or cells obtained domestically, the manufacturer must inform the consent giver of the relevant regulations prior to obtaining their consent. The consent giver must sign and date the informed consent form. Additionally, the person explaining the information and receiving the consent form must also sign and date the document. The content of the informed consent form must be reviewed and approved by an ethics review committee. Manufacturers must not obtain consent through coercion, inducement, or any other improper means.
If an approved consent form is later discovered to lack critical information that could influence the decision of the consent giver, the use of the obtained tissues or cells must be suspended. The form must be revised and resubmitted to the ethics review committee for approval, and new consent must be obtained before proceeding with the collection (Articles 2 and 4 of the Regulation Four).
(2) Exportation for Overseas Manufacturing
If a regenerative medicinal products distributor obtains tissues or cells from domestic donors and subsequently exports them for overseas manufacturing, the same requirements for documentation and ethics review of informed consent shall apply (Article 3 of the Regulation Four).
(3) Retention of Consent Forms
A regenerative medicinal products manufacturer must retain informed consent forms for at least 30 years from the date of receipt (Article 5 of the Regulation Four).
Related Articles
Series Articles of the Regenerative Medicine Dual Legislation (1) – Taiwan's Legislative Yuan Passed the Regenerative Medicine Dual Legislation Series Articles of the Regenerative Medicine Dual Legislation (2) – Analysis of the Conditional Approval System for Regenerative Medicine Product Series Articles of the Regenerative Medicine Dual Legislation (3) – The Impact of the Regenerative Medicine Dual Acts on the Therapy and Drug Development of Rare Diseases
