Series
Regenerative Medicine
Regenerative medicine in Taiwan has moved through three periods: before 2010, regulated as a technology; from 2010 to 2018, learning from the United States to regulate it as a drug; and from 2018, operating on dual tracks. In January 2026, Taiwan's two regenerative-medicine acts formally took effect.
This series begins with access to NHI data, then moves through structures of responsibility and routes to market access, to the competent authority's first public explanation six months after implementation. A Japanese industry case appears in the middle. Later articles return from market claims to the technology itself: how to read a cross-border advertisement, what mesenchymal stem cells actually do in the body, and what stable manufacturing and delivery require.
Regulatory and Industry Updates
Regulator announcements, rule changes and industry news since Taiwan's two regenerative medicine laws took effect, newest first. Each item links to its original source, most of which are in Chinese. Regulator announcements, institutional notices, company announcements and media reports are labelled separately.Last updated
Health minister: Taiwan will see a landmark drug license
According to Economic Daily News, Health and Welfare Minister Shih Chung-liang said in his address at the newspaper's 2026 Biotech Forum on October 7 that Taiwan's two regenerative medicine laws took effect in January and that Taiwan will also see a landmark drug license, giving regenerative medicine a real chance to obtain drug licenses. The report did not say which license he meant or when it would be approved.
National Health Insurance covers the CAR-T cell therapy Yescarta from October 1
On September 15 the National Health Insurance Administration announced (NHIA notice No. 1150056971) provisional reimbursement and coverage rules for Yescarta, which contains axicabtagene ciloleucel, and revised the coverage rules for drugs containing tisagenlecleucel (such as Kymriah), effective October 1. An NHIA press release on October 2 said the CAR-T therapy is for some adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma, adding a treatment option for relapsed or refractory patients.
Source: NHIA announcement (in Chinese)
UnicoCell Biomed's allogeneic adipose mesenchymal stem cells receive an export-only drug license
UnicoCell Biomed (6794) announced on October 1 that its human allogeneic adipose-derived mesenchymal stem cells, UC-hADSC, received an export-only drug license from the Ministry of Health and Welfare (MOHW license No. 000164). The company called it the first cell therapy product in Taiwan to obtain this kind of export license.
StemCyte International files with TFDA to register its cord blood cell product REGENECYTE as a regenerative medicine product
StemCyte International (4178) announced that it has applied to the Taiwan Food and Drug Administration (TFDA) to register its cord blood cell product REGENECYTE as a regenerative medicine product. The product already holds a U.S. FDA biologics license; the company said the approved uses and indications will depend on TFDA's final review.
Ministry of Health and Welfare sets biomedical investment rules, with regenerative medicine as a priority
On August 27 the Ministry of Health and Welfare issued operating rules for its program to invest in Taiwan's biomedical industry: strategic government investment of NT$10 billion over 10 years, with co-investors selected through an open process. Regenerative medicine is within scope; for priority targets such as regenerative medicine, co-investors and the trust account may invest at a 1:2 ratio.
Earlier updates (11)
The Reporter investigates unregulated exosome injections
The Reporter published an investigation into underground exosome injections and claims about their effects. It reported that in Taiwan exosomes may currently be used only as cosmetic ingredients applied to the skin, and that as of publication no exosome therapy had been approved for medical use, either as a regenerative medicine technique or as a product.
Chang Gung passes FACT accreditation for cellular therapy
According to Business Today on October 7, Chang Gung Medical Foundation passed accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT) on August 18. Chang Gung said the accreditation covers three stages: clinical care, cell collection, and cell processing.
Health minister hopes to see the first conditionally approved regenerative products by year end
Health and Welfare Minister Shih Chung-liang said in a forum speech that this is Taiwan's "first year of regenerative medicine", that a guidance program for regenerative medicine products has been set up, and that he hopes to see the first conditionally approved regenerative products by the end of the year.
Source: CNA (via United Daily News), 2026-08-15 (in Chinese)
TFDA publishes guidance on clinical trial applications for human extracellular vesicle products
TFDA published its guidance on clinical trial applications for human extracellular vesicle products (FDA notice No. 1151403418), giving developers of extracellular vesicle (exosome) products a reference when applying for clinical trials in Taiwan.
Source: TFDA announcement (in Chinese)
Ministry of Health and Welfare launches the Taiwan Regenerative Medicine Advanced Therapy guidance program (T-RMAT)
The Ministry of Health and Welfare set up the guidance program by order No. 1151401116, combining the expertise of TFDA and the Center for Drug Evaluation (CDE) to give regulatory science advice. Provided the rules have not changed and the application matches what was reviewed during guidance, the guidance conclusions bind later applications. Eligible are regenerative medicine products developed and made in Taiwan whose clinical trials run in Taiwan with a study population matching the claimed indication, or extracellular vesicles developed and made in Taiwan. Participants are in principle also limited to cases already in TFDA's drug consultation program and designated as CDE regulatory science consultation indicator cases, and the indication must have public health value and urgent clinical need. For products that finish guidance, hold the certificate and declare that their application matches the guidance review materials, clinical trial review takes 15 days in principle and marketing approval (including conditional approval) 120 days.
Source: TFDA program page (in Chinese)
Center for Drug Evaluation opens a regenerative medicine section
In response to the two laws taking effect, the Center for Drug Evaluation set up a regenerative medicine section on its website collecting the relevant regulations, guidelines, TFDA-approved regenerative medicine clinical trials, consultation services, and review perspectives and regulatory articles.
Ministry of Health and Welfare issues application instructions for conditional approval of regenerative medicine products
The Ministry of Health and Welfare sent the instructions by letter No. 1151400006, explaining how to apply for conditional approval; TFDA posted them on March 5. Under Article 9 of the Regenerative Medicine Products Act, conditional approval applies to products that treat life-threatening or severely disabling diseases, have completed Phase II clinical trials and, after a risk-benefit review, show safety and preliminary efficacy. It lasts no more than five years and cannot be extended.
Ministry of Health and Welfare revises application documents for regenerative medicine technique plans
By letter No. 1151661075 the Ministry of Health and Welfare announced that the instructions for using designated regenerative medicine products and the format for annual reports on regenerative medicine techniques are available in its regenerative medicine technique section, and that it has revised the application instructions and the plan template for regenerative medicine technique plans, for medical institutions to download.
Source: MOHW letter (via Taiwan drug regulation portal, in Chinese)
TFDA opens online filing for regenerative medicine product cases
By letter No. 1141404345 TFDA announced that its online drug registration review and filing platform (ExPRESS) now accepts regenerative medicine product cases. New applications, changes, renewals, inquiries and recruitment advertisements must all be filed online; paper submissions are not accepted.
Source: TFDA letter (via Taiwan drug regulation portal, in Chinese)
Ministry of Health and Welfare issues four rules including regenerative medicine ethics
By notice No. 1141671851 the Ministry of Health and Welfare issued four rules: the regenerative medicine ethics rules; the requirements for medical institutions applying to use regenerative techniques to treat life-threatening or severely disabling diseases for which no suitable drug, device or technique is available in Taiwan; the qualification rules for physicians performing regenerative medicine; and the requirements for relief measures when a regenerative medicine technique causes serious injury or death.
Taiwan's two regenerative medicine laws take effect
The Regenerative Medicine Act and the Regenerative Medicine Products Act were promulgated on June 19, 2024, and the Executive Yuan set January 1, 2026 as their effective date. The first mainly governs how medical institutions perform regenerative techniques, use designated regenerative products and manage the cells involved; the second governs regenerative medicine products made or imported by pharmaceutical firms.
- How Hard Is It to Find Taiwan's NHI Data in English or JapanesePublic data isn't the same as usable data: a single ODT page, and a trilingual lookup tool.
- Why a rare disease certificate lasts forever, but cancer only three yearsThirty years of actuarial calculation behind the catastrophic-illness certification tiers, and an early prototype of tiered reimbursement.
- Why Taiwan Allows Certain Cell Therapies That Have Completed Phase II to "Reach Market Conditionally First, Then Complete Verification Later"Two laws, conditional approval, and T-RMAT: the accelerated pathway for cross-border cell therapies entering Taiwan.
- A Map of Authority in Regenerative MedicineTFDA and the Department of Medical Affairs hold power written into law; CDE holds power written into a delegation agreement.
- Umbilical Cord Cells vs. Sarcopenia: Reframing Aging as an Inflammation Problem We Can Actually SolveA Japanese startup reframes aging as a fire that can be put out. (An industry case.)
- Asia-Pacific Regenerative Medicine Trials Surpass North America for the First Time — Where Does Taiwan Stand?Notes from Minister Shih Chung-liang's lecture, part one: the market's shift in scale, and Taiwan's early-phase strategy.
- Why Taiwan Rejected Both the U.S. and EU Models: The Logic Behind Its Dual-Track Regenerative Medicine FrameworkLecture notes, part two: the design logic of the dual-track system, and the five criteria for conditional approval.
- A Million-Dollar Dose: How Does Taiwan Plan to Pay for It?Lecture notes, part three: current approval status, the 180-day target, and the Asia-Pacific Rare Disease Center.
- "Reported to the Government" Does Not Mean "Government Approved"Japan's notification system, Taiwan's pre-screening of ads, and the cross-border ad caught in between.
- Before You Click on a Stem Cell Ad, Spend Three Minutes Doing ThisCheck the indication against the official database once, plus six phrases that should make you stop.
- After MSCs Enter the Bloodstream, Where Do the Cells Actually Go?The cells get stuck in the lungs and don't survive a day — and that's exactly how they work.
- What Manufacturing Capabilities Does Regenerative Medicine Need to Scale?After understanding what cells do, this article considers how potency, process changes, and technology transfer support reliable delivery.
Further reading
- What Makes Biomedical Data Use Trustworthy?
A further look at research permission, withdrawal, and exchange of personal health data. These questions are distinct from the readability of public NHI information addressed in the series.
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