Series

Regenerative Medicine

Regenerative medicine in Taiwan has gone through three phases: managed as a medical technique before 2010, managed as a drug under the U.S. model from 2010 to 2018, and running on dual tracks since 2018. In January 2026, Taiwan's two regenerative medicine laws formally took effect.

This series starts with a question about the accessibility of NHI data, moves through the structure of regulatory authority and approval pathways, and continues to the regulator's first public account six months after implementation. Along the way, it includes a Japanese industry case. The final three pieces turn to the market itself: when a technology outruns the institutions meant to contain it, how does a cross-border advertisement get read, and what do mesenchymal stem cells actually do once they're in the body?

How Hard Is It to Find Taiwan's NHI Data in English or Japanese Public 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 years Thirty 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 Medicine TFDA 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 Solve A 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 Framework Lecture 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 This Check 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.

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