Yueh-Ping Liu
Department of Medical Affairs,
Ministry of Health and Welfare, Taiwan

To respond to the rapid advancement of frontier medical technologies and the public’s growing expectations for more comprehensive healthcare options, the Ministry of Health and Welfare (MOHW) has long been committed to establishing a transparent and data‑driven governance framework for emerging medical technologies. The public proposals submitted through the national online policy participation platform in 2015 highlighted the actual needs of patients and families seeking access to cancer immunotherapy and cell‑based treatments. These inputs enabled the MOHW to incorporate public sentiment directly into policy planning in a timely manner. This milestone prompted the government to initiate cross‑ministerial collaboration, gradually shaping a national‑level blueprint for regenerative medicine policy.

In 2018, the MOHW completed a major revision of the Regulations Governing the Application or Use of Specific Medical Techniques, Examinations, and Medical Devices, formally integrating cell therapy into a structured regulatory system and ensuring the safe, professional oversight of these technologies.

In 2026, the implementation of the Regenerative Medicine Act and the Regenerative Medicinal Products Act marked Taiwan’s entry into a new stage of comprehensive legal governance, establishing clear responsibilities and aligning regulatory structures with international trends.

Amid the global expansion of regenerative medicine, the MOHW bears the dual responsibility of safeguarding patient safety while supporting medical innovation. To achieve this balance, the government has adopted a risk‑stratified and dual‑track regulatory model—comprising a technique track and a product track—to ensure that every stage, from preparation and validation to clinical application, adheres to clear quality standards and safety requirements, while continuous monitoring and scientific assessment support ongoing policy refinement. Under the technique track, autologous cell therapies are performed by medical institutions within Good Tissue Practice (GTP)–compliant manufacturing environments.

Under the product track, regenerative medicinal products are governed by the Pharmaceutical Affairs Act, requiring compliance with Good Manufacturing Practice (GMP)standards and market authorization to ensure product quality meets international standards.

As of the end of 2025, a total of 468 cell therapy implementation plans had been approved nationwide, with 2,365 patients receiving treatment. The MOHW compiles these implementation outcomes into annual reports, which serve as an important basis for policy adjustment, risk management, and enhanced international transparency. To address illegal medical practices and misleading advertisements, the dual‑law framework strengthens inspection and enforcement mechanisms, including substantial fines, public disclosure of violations, and, when necessary, confiscation of equipment, in order to protect public rights and promote a responsible healthcare environment.

With respect to exosome‑based therapies, a topic of significant public attention, the MOHW adheres to a principle of “evidence first, patient safety foremost.” Due to the current immaturity of clinical evidence, exosome therapies are not permitted for routine clinical use. The MOHW will continue monitoring global research developments, convening expert consultations, and reviewing regulatory approaches as appropriate. The MOHW urges the public to avoid unapproved treatments and requires medical institutions to uphold professional ethics and comply with legal standards.

Regenerative medicine is not only a scientific endeavor but also an embodiment of public values and patient rights. The MOHW places great emphasis on informed consent, patient participation in decision‑making, and the quality of communication between healthcare providers and patients.

Moving forward, the MOHW will continue advancing digital governance by establishing interoperable data systems across institutions, strengthening cybersecurity and personal data protection, leveraging artificial intelligence and big‑data analytics for risk surveillance, and integrating genomic, imaging, and medical record data to support a comprehensive ecosystem for data‑driven decision‑making.

The year 2026 marks the inaugural year of implementation of Taiwan’s dual regenerative medicine laws and an important governance milestone in the field of emerging medical technologies. The MOHW will remain committed to advancing regenerative medicine guided by scientific evidence, transparency, and a patient‑centric approach. Together with the medical community, industry, and the public, the MOHW aims to build a safe, ethical, and sustainable regenerative medicine environment and strengthen Taiwan’s competitiveness in the global regenerative medicine landscape.

Dr. Yueh-Ping Liu

Director-General

Department of Medical Affairs

Ministry of Health and Welfare