Taiwan Rolls Out Lifecycle Implementing Rules for Regenerative Medicine Preparations

Regulatory authorities in Taiwan have issued several implementing rules under the “Regenerative Medicine Preparations Act,” setting enforceable requirements for registration, donor suitability, recruitment advertising, and post-market traceability. Each regulation is issued under specific authorization provisions of the Act and addresses a defined regulatory function within the overall framework.

For foreign manufacturers and overseas license holders, these rules define how regenerative medicine preparations are regulated across the product lifecycle. Key requirements address:

• The sourcing and suitability assessment of human tissues and cells
• The recruitment and informed participation of tissue and cell providers
• The registration, review, and conditional approval of regenerative medicine preparations
• The preservation of supply, distribution, and patient usage data after market entry

At a Glance

The newly issued implementing regulations activate Taiwan’s regulatory controls for regenerative medicine preparations through clear, role-based obligations across the product lifecycle:

• Manufacturers, importers, and other preparation license holders carry primary compliance responsibility for donor suitability, recruitment advertising, registration, and traceability obligations.
• Human tissue- or cell-derived preparations are subject to enhanced screening, documentation, and long-term data retention requirements
• Post-market obligations include batch-level traceability, inspection exposure, and strict personal data protection duties
• Foreign companies should promptly assess compliance readiness and contact Cisema for regulatory interpretation support

Regulatory Context and Overall Structure

The Regenerative Medicine Preparations Act establishes the legal basis for regulating regenerative medicine preparations. Rather than consolidating all requirements into a single regulation, Taiwan has adopted a modular regulatory approach.

Each implementing regulation governs a discrete function, such as provider suitability, advertising conduct, registration review, or data preservation. This structure forms a lifecycle framework and allows regulators to apply targeted oversight at each stage.

Controls on Human Tissue and Cell Sourcing

The regulatory framework begins at the source. For regenerative medicine preparations derived from human tissues or cells, Taiwan places primary emphasis on preventing biological risk before manufacturing or importation occurs. As a result, sourcing controls are positioned as a gatekeeping mechanism that determines whether downstream regulatory steps may proceed at all.

Responsibility for Determining Tissue and Cell Provider Suitability

Responsibility for determining provider suitability rests with regenerative medicine preparation manufacturers or import license holders acting as licensed pharmaceutical dealers. These entities may perform screening, testing, and suitability determination internally or entrust these activities to qualified contracted institutions.

To ensure professional oversight, both license holders and contracted institutions must designate a physician with at least one year of practical experience in specified regenerative medicine–related fields. These include oncology or cell therapy, basic or clinical immunology, cell banking, or blood banking. The designated physician is responsible for overseeing suitability determinations and for establishing and maintaining documented standard operating procedures that support regulatory inspection.

Screening Standards and Disqualifying Conditions for Providers

The regulations specify defined circumstances under which a tissue or cell provider may not be determined suitable. These circumstances include:

• Detection of infectious diseases listed in Annex 1, such as HIV, hepatitis B and C, syphilis, human transmissible spongiform encephalopathy, and tuberculosis
• Presence of 29 enumerated high-risk conditions listed in Annex 2, including specified sexual behaviors, non-medical drug injection, unsterilized tattoos or piercings, malignant tumor history, and prior gene therapy

Exceptions are permitted only in narrowly defined circumstances — urgent medical needs or provision to first- or second-degree blood relatives — and only after the patient has been notified and has provided written informed consent.

Special Sourcing Scenarios and Recordkeeping Obligations

The regulations adapt suitability requirements to specific sourcing scenarios while preserving traceability and accountability.

For neonates within one month of birth, screening applies to both the neonate and the birth mother, while testing applies only to the mother. If maternal specimens cannot be obtained, the neonate may not be determined suitable as a provider.

Where tissues or cells are collected solely for autologous use, formal suitability determination is waived. However, screening and testing remain mandatory, and associated records must still be preserved. Products intended for this use must be clearly labeled “For Autologous Use Only.”

All suitability determination reports, including screening and testing records in autologous scenarios, must be retained for at least 30 years after the preparation’s shelf life expires, reinforcing long-term accountability.

Rules Governing Recruitment of Tissue and Cell Providers

After defining who may provide tissues and cells, the regulations address how tissue and cell providers may be recruited. These rules are created to address concerns that inappropriate advertising could compromise informed consent or exploit vulnerable populations.

Pre-Approval and Mandatory Information in Recruitment Advertisements

Before publishing or broadcasting advertisements for the recruitment of tissue and cell providers, the drug license holder or conditional approval holder must apply for approval, submit required documentation, and pay review fees to the reviewing authority.

Approved advertisements must clearly disclose:

• The name and address of the license holder
• The name and address of the tissue and cell collection medical institution
• Recruitment criteria
• Corresponding regenerative medicine preparation names and collection methods
• Contact information and the approval number

These disclosures ensure that potential providers receive complete and accurate information before consenting to collection. Advertising approvals are valid for a maximum of one year and may not exceed the validity of the relevant license. Extensions must be requested three months in advance.

Prohibited Advertising Content, Methods, and Locations

The regulations prohibit claims that tissue or cell collection is harmless, exaggerated benefits, coercive inducement, disparagement of competitors, or content violating public order and good customs.

The regulations further prohibit promotion through recruitment media or social networking sites, as well as through disguised formats such as interviews or news reports. Publication is expressly prohibited in specified locations, including childcare centers, children and youth welfare institutions, and campuses of high schools and below.

Product Registration and Market Approval for Regenerative Medicine Preparations

With sourcing and recruitment controls established, the regulatory framework next addresses the registration and market approval of regenerative medicine preparations.

Scope of Preparations and Regulatory Actions Covered

The registration rules apply to cell therapy preparations, gene therapy preparations, tissue engineering preparations, and combination preparations. They govern initial registration, drug license issuance, conditional approval, and all subsequent regulatory actions, including changes, transfers, extensions, renewals, and re-issuances.

Product names, labels, and packaging must comply with the “Regulations Governing Medicinal Product Registration,” with additional requirements for conditionally approved products.

Registration Dossiers

Applicants must submit administrative and technical documentation as specified by the regulations. Key components include:

• Mandatory Data: All categories must submit proof of fee payment, registration application form, package insert and label mockup, license mockup (including pharmaceutical dealer license, company/business registration, etc.; imported preparations are exempt from factory registration), power of attorney (for imported preparations), risk assessment and management plan, and GMP/GDP certification documents.
• Optional Data: Certificate of Pharmaceutical Product (CPP) from the country of origin (submitted for imported preparations on a case-by-case basis).
• Risk Assessment and Management Plan: For specific preparations announced by the central competent authority, this must be submitted within 90 days of receiving the license; for others, if required by the authority, it must be drafted and submitted before licensing as a basis for review.

Technical Evidence Requirements

Technical documentation must follow the Common Technical Document format and address origin and usage, quality and manufacturing control, non-clinical safety and pharmacology, and clinical evidence.

1. Origin and Usage: Discovery history, domestic and international use, and comparison with similar preparations
2. Quality and Manufacturing Control: Raw materials, reagents, excipients, process controls, characterization, inspection specifications, and certificates of analysis to support traceability
3. Safety and Pharmacology Test Data: Mandatory assessments include adventitious agent safety and single- and repeat-dose toxicity. Safety pharmacology and reproductive toxicity studies are mandatory for gene therapy preparations and assessed case by case for other categories. Pharmacology data must cover primary pharmacodynamics, in vivo kinetics, and shedding
4. Clinical and Other Data: Clinical trial reports are mandatory. Medical literature may be submitted as supplementary material. Applicants must also provide container closure system information and stability testing protocols and reports demonstrating stability during storage, transportation, and use

Special Additional Requirements for Human Tissue– or Cell–Derived Preparations

For preparations derived from human tissues or cells, applications must also include:

1. Standard operating procedures for screening, testing, and suitability determination, along with suitability determination summary reports for representative batches
2. A blank informed consent form for providers, where tissues or cells are sourced domestically

Conditional Approval Pathways and Evidence Flexibility

Applicants seeking conditional approval must submit written explanations addressing statutory conditions and complete license collection procedures within three months of notification:

1. Submit approved labels, inserts, and packaging (physical or color drafts)
2. Complete the filing of drug appearance and approved labels/inserts/packaging on the drug insert query platform
3. Submit the original notification letter stamped with the applicant's and person-in-charge's seals
4. Attach the approved draft, application copy, and license copy

Authorities require applicants to correct deficiencies within authority-notified deadlines and, where applicable, to supplement required documents before license collection.

In addition to clinical trial reports, applicants may submit Real-World Evidence as supplementary material. Evidence assessment may also incorporate patient-focused drug development concepts as part of the risk-benefit assessment.

Where deemed necessary, the competent authority may require applicants to submit product samples for examination as part of the registration review process.

Post-Market Traceability and Data Preservation Requirements

Following market entry, regulatory oversight continues through long-term traceability obligations. Regulations governing the preservation of data on supply sources and flows ensure that preparations remain traceable throughout distribution and clinical use.

Data Retention Responsibilities Across the Supply Chain

The regulations allocate data preservation duties by role:

• Preparation license holders must retain manufacturing or import records, active ingredient information — including tissue or cell tracking codes where applicable — and detailed supply flow data
• Preparation wholesalers must retain supplier information and downstream distribution records
• Medical institutions must retain supplier information and batch-based patient usage records, including patient name, identification number, and contact details

Pharmaceutical dealers must preserve relevant data for at least 30 years after the preparation’s shelf life expires. Medical institutions must preserve data for at least 15 years from the date of use, and where preparations are used in pediatric patients, records must be retained until the patient reaches adulthood plus an additional 15 years.

Inspection Authority and Personal Data Protection

Competent authorities may conduct regular or irregular inspections, request data and supporting documents, and perform on-site inspections. Regulated entities may not evade, obstruct, or refuse inspections. Authorities may invite scholars, experts, or institutional representatives to participate.

All collection, processing, and use of personal data must comply with the “Personal Data Protection Act” and related regulations.

Final Thoughts: What This Framework Means for International Companies

Taken together, the implementing rules establish an enforceable regulatory framework covering registration, donor suitability, recruitment advertising, and post-market traceability for regenerative medicine preparations in Taiwan. Although issued as separate instruments, they operate collectively to extend regulatory oversight from source qualification through post-market monitoring.

For foreign manufacturers and import license holders, market access now depends on coordinated compliance across sourcing, advertising, documentation, and long-term data preservation requirements, particularly where human tissues or cells are involved.

Further Information

• Explore Cisema’s pharmaceutical consulting services
• Read Taiwan Strengthens Dual-Track Framework: New Monitoring Measures for Regenerative Medicine

References

Read the official announcements from the Taiwan FDA in Traditional Chinese:

• Formulation of the “Regulations for the Preservation of Regenerative Medicine Preparation Supply Sources and Flow Information”
• Formulation of the “Regulations Governing the Publication of Recruitment Advertisements for Tissue and Cells Used in Regenerative Medicine Preparations”
• Formulation of the “Regenerative Medicine Preparation Inspection, Registration, and License Review Guidelines”
• Formulation of the “Measures for Determining the Suitability of Tissue and Cell Donors for Regenerative Medicine Preparations”