Taiwan Strengthens Dual-Track Framework: New Monitoring Measures for Regenerative Medicine

On 25 August 2025, Taiwan enacted the “Safety Monitoring and Management Measures for Regenerative Medicine Products”, enhancing post-market oversight of regenerative therapies. This update builds on two foundational laws enacted in June 2024—the “Regenerative Medicine Act” and the “Regenerative Medicinal Products Act”—which together establish a dual regulatory framework covering clinical use and product commercialisation.

For biotech companies, these regulations create a clear, structured pathway into Taiwan’s emerging regenerative medicine market.

Taiwan’s Emerging Role in Global Biotech

Taiwan is actively positioning itself as a regional hub for biomedical innovation. Through comprehensive regulatory reform, it aims to attract global leaders in cell and gene therapies, tissue engineering, and combination products.

Central to this vision is Taiwan’s dual regulatory framework, which separates:

Clinical practice oversight (via the Regenerative Medicine Act), and
Product lifecycle regulation (via the Regenerative Medicinal Products Act).

This mature, internationally aligned structure harmonises with ICH, FDA, and EMA standards, offering enhanced clarity, speed, and predictability. It particularly benefits companies with advanced clinical data seeking entry into new markets.

Alongside regulation, Taiwan fosters international collaboration through high-level forums and strategic research partnerships. Recent government-backed initiatives have targeted CAR-T therapies, 3D bioprinting, and in vivo gene editing—highlighting strong support for cutting-edge innovation.

Collectively, these efforts position Taiwan not just as a regulatory gateway but as a strategic launchpad for regional expansion, especially into Japan and Southeast Asia.

Taiwan’s Dual Framework: Two Legislative Pillars

Understanding Taiwan’s regenerative medicine framework begins with the two core legislative pillars that underpin it: the Regenerative Medicine Act, which governs clinical use, and the Regenerative Medicinal Products Act, which oversees product development and commercialisation.

The Regenerative Medicine Act (再生醫療法)

This Act governs clinical application of regenerative therapies, setting strict rules for clinical deployment, ensuring patient safety, ethical compliance, and institutional oversight.

Key Provisions

Clinical use is restricted to licensed medical institutions
Compassionate use allowed for life-threatening conditions without alternatives
Prohibition of xenogeneic therapies
Rigorous donor consent protocols with special protections for vulnerable groups
Heavy fines (up to NT$20 million) for unauthorized practice or advertising by non-medical entities

Implications for Biotech

Successful clinical deployment requires strong partnerships with hospitals, thorough understanding of legal and ethical obligations. In addition, it requires operational readiness that extends well beyond standard product registration.

With the clinical oversight structure established, companies can advance toward market entry.

The Regenerative Medicinal Products Act (再生醫療製劑條例)

This Act regulates the development, approval, and commercialisation of regenerative products, offering a fast-track approval route for innovative therapies.

Key Features

Applies to gene therapies, cell therapies, tissue-engineered products, and device-combination therapies.
Allows conditional approval after Phase II trials for high-need indications, valid for up to five years.
Requires full compliance with GMP, GDP, and GCP, and mandates certified personnel for manufacturing and quality control.
Enforces strict standards for donor eligibility, informed consent, and data traceability.

Key Takeaway

For companies with promising Phase II data—particularly in oncology or rare diseases—this Act provides a clear, accelerated pathway to early market access. Once a product is approved, however, companies must maintain compliance through robust post-market surveillance.

Safety Monitoring and Management Measures (再生醫療製劑安全監測及管理辦法)

Market entry marks just the start of regulatory responsibilities. Taiwan’s “Safety Monitoring and Management Measures for Regenerative Medicine Products” establish comprehensive post-market surveillance requirements that align closely with international pharmacovigilance standards.

These measures ensure ongoing accountability, safeguard patient safety, and maintain regulatory integrity throughout the product lifecycle.

Key Obligations

Submission and approval of Safety Monitoring Plans for high-risk products.
Adverse event reporting within three days, especially when linked to global withdrawals.
Periodic Safety Update Reports (PSURs) every six months for the first two years, then annually, per ICH E2C(R2) guidelines.
Mandatory Risk Management Plans within 90 days of licence issuance.
Long-term data retention: 10 years for most products, 20 years for gene therapies.

Failure to meet these obligations can lead to licence suspension or revocation.

Next Steps for Biotech Executives

To succeed in Taiwan’s regenerative medicine market, biotech leaders must plan strategically and act proactively.

Audit Regulatory Readiness: Benchmark Taiwan’s requirements against EU or US frameworks to identify gaps in strategy, compliance, and resources.
Localise Safety Systems: Adapt pharmacovigilance and data management processes to meet Taiwan’s post-market obligations.
Engage Early with Taiwan FDA: Conditional approval pathways require proactive engagement and local strategic planning.
Collaborate with Experienced Partners: Work with local regulatory consultants to address language barriers, dossier requirements, and inspection protocols efficiently.

Following these steps positions companies for successful regulatory approval and sustainable market growth in Taiwan.

The Bottom Line

Taiwan’s recent regulatory updates—the “Regenerative Medicine Act”, “Regenerative Medicinal Products Act”, and the new “Safety Monitoring and Management Measures”— create a cohesive and efficient framework for regenerative medicine. This harmonised system offers biotech companies faster, safer market entry while aligning with global standards, establishing Taiwan as a strategic hub for regional biotech expansion.

Cisema provides end-to-end regulatory support—including strategy, compliance, dossier preparation, and local representation—to help biotech companies expanding into Taiwan. For expert guidance, contact Cisema today.