TL;DR — After the Regenerative Medicine Dual Acts take effect on January 1, 2026, Taiwan is gradually forming three layers of interlocking institutional design: the parent statutes of the Regenerative Medicine Dual Acts, the “approval with conditions” (also referred to in this article as conditional approval) under Article 9 of the Regenerative Medicine Products Act, and the “Taiwan Regenerative Medicine Advanced Therapy Pilot” (T-RMAT) announced by the TFDA and the CDE in March 2026. Compared against international systems, this design belongs to the same policy trend as the US RMAT, the EU PRIME, and Japan’s Sakigake in offering accelerated pathways for regenerative medicine. The point is not “relaxing review,” but rather: for qualifying products, the competent authority may—when benefit-risk is already preliminarily supported—trade post-market verification, risk management, and ongoing surveillance for the possibility of patients gaining treatment options earlier. Taiwan’s regulatory framework is largely in place; what is more worth watching next is whether industry actually submits applications along this pathway and accumulates verifiable market cases.

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Recently we have been evaluating the possibility of bringing a cell therapy to market in Taiwan. The therapy has already entered the mid-to-late stage of clinical evaluation, and we are currently making a preliminary assessment of its clinical value, regulatory pathway, and commercialization model. My initial intuition was that this pathway would still depend heavily on a complete Phase III, additional local trials, and a long wait for market entry. But once you take the system apart, you find that over the past few years Taiwan has in fact gradually laid out a pathway quite different from the conventional imagination.

Behind this therapy is a group of patients who have already waited many years. Many regenerative medicine therapies already demonstrate meaningful efficacy at the Phase II stage in the US, yet patients in Taiwan typically have to wait another 5 to 10 years. By the time US Phase III is complete, the product reaches market, is brought into Taiwan, and clears health insurance reimbursement, some people can no longer wait. For diseases that progress quickly, every link that can be shortened is, in real terms, an option.

In June 2024, the Legislative Yuan passed on third reading the Regenerative Medicine Act and the Regenerative Medicine Products Act, which were promulgated by the President and take effect on January 1, 2026. At the same time, the TFDA and the CDE also introduced the “Taiwan Regenerative Medicine Advanced Therapy Pilot” (T-RMAT), announced and launched in March 2026, as a complementary measure to strengthen early regulatory communication, review planning, and pre-submission guidance. With these several systems layered together, therapies that “already possess Phase II evidence and target life-threatening or seriously debilitating diseases” do indeed face a more discussable possibility of accelerated entry in Taiwan than in the past.

This pathway carries at least two common misunderstandings. First, many people, upon hearing “conditional approval may be applied for after completing Phase II,” intuitively wonder whether this means review standards are being relaxed. Second, many multinational pharmaceutical companies, when evaluating Asian markets, may still regard Taiwan as a market that traditionally takes on US and European data relatively late, and have not yet incorporated the conditional approval and guidance pilot under the new system into the same strategic calculus. In fact, both of these intuitions deserve to be re-examined.

Why can completing Phase II make a product eligible to apply for market entry? How the three layers stack up

Returning to the Regenerative Medicine Products Act itself, the conditional approval designed under Article 9 is one of the cores of this pathway. According to the provisions, an applicant must simultaneously satisfy specific disease attributes, clinical trial progress, and benefit-risk data conditions; not every product that has completed Phase II can apply directly.

First, the indication must be for a “life-threatening disease” or a “seriously debilitating disease.” “Life-threatening” refers to a disease that has progressed to a stage where death may reasonably occur within several months, or where premature death may occur if not treated early—the emphasis being on the imminence of the risk of death. “Seriously debilitating” refers to a disease that has severely impaired bodily function, affected daily life, or rendered the patient unable to live independently, and that may further deteriorate if untreated. Transient sequelae or complications that resolve on their own are not included.

Second, the applied-for product must have completed Phase II human trials. In other words, the product is not still at the proof-of-concept stage, but has already accumulated safety and preliminary efficacy data of a certain scale in trial subjects.

Third, the applicant must submit data sufficient to support a benefit-risk assessment, and only after the competent authority’s review deems it to have safety and preliminary efficacy, and it has been approved by the Regenerative Medicine Review Committee, may conditional approval be obtained. The role of this review committee is to bring the perspectives of medicine, ethics, industry, patients, and review practice onto one table, and to decide whether a particular product is worth trading “early market entry” for “subsequent verification obligations.” In other words, this is not “finish Phase II and reach market,” but rather “only after finishing Phase II does a product become eligible to be rigorously discussed for whether it may reach market conditionally.”

After obtaining approval with conditions, the developer receives a license valid for a maximum of five years that cannot be extended. During this period, the developer must continue to conduct efficacy verification trials, or submit real-world data (RWD) studies with substantial evidentiary support, and periodically submit data to the competent authority. If the attached obligations are not fulfilled, or a major safety concern arises, the competent authority may revoke the approval with conditions.

So this ticket is not a blank check. It is more like a time-limited entry qualification with attached obligations that may be withdrawn at any time. The first phase trades the completed Phase II data, benefit-risk review, and committee judgment for early access; the second phase requires continuing to conduct efficacy verification trials after market entry and periodically submitting data. If the obligations are not fulfilled, or the competent authority assesses that a major safety concern has arisen, the approval may be revoked. This is a different matter from “relaxing review”—the latter directly lowers standards, while the former changes part of the evidence requirements into phased fulfillment.

The second layer is the parent-statute framework of the Regenerative Medicine Dual Acts. The Regenerative Medicine Act regulates the execution side—medical institutions—covering matters such as physician qualifications, institutional facilities, human trials, informed consent, and adverse reaction reporting. The Regenerative Medicine Products Act regulates the product side, bringing everything from registration review, approval with conditions, manufacturing and distribution, and post-market management to drug-injury relief into a “full lifecycle management” framework similar to that for conventional drugs. For developers, this means the standard for competitiveness is no longer only scientific technology, but also includes PIC/S GMP, GDP, batch consistency, distribution tracking, cold-chain logistics, and long-term risk management capability.

The third layer is T-RMAT. The TFDA and the CDE announced T-RMAT in March 2026, positioning it as an accelerated guidance mechanism whose purpose is to allow qualifying regenerative medicine product developers to establish scientific consensus with the review side before formal submission, and to align the direction of clinical, CMC (chemistry, manufacturing, and controls), toxicology, statistical, and other data with review standards from the outset. The planned guidance model includes biweekly two-way communication with the two agencies, rolling review, written review opinions, and a binding effect of early consultation conclusions on subsequent submissions when conditions remain consistent. When a developer ultimately chooses to submit for approval with conditions or a BLA (Biologics License Application), the target review timeline can be compressed to 120 days, while for an IND (clinical trial application) the target is 15 days. These figures are target review timelines as publicly stated by the competent authority; actual submission outcomes still depend on the completeness of case-specific data.

In practice, to enter T-RMAT, the following categories of projects will be prioritized for support: regenerative medicine products already covered by existing TFDA or CDE guidelines and consultation programs; products planning to apply for a BLA (including approval with conditions) between 2026 and 2027; first-in-human trials of exosomes or extracellular vesicles (exosome/EV); and regenerative medicine products with public health value and high clinical urgency.

Putting the three layers together, what you see is not just three independent tools, but a continuous design of “alignment at the scientific consultation stage → clear thresholds for approval with conditions → continuation into post-market verification and safety surveillance.”

Placing Taiwan back on the map of international accelerated pathways

Placed within the global coordinate system, this pathway is not an isolated case. The US FDA’s RMAT designation (Regenerative Medicine Advanced Therapy) has been in operation since the passage of the 21st Century Cures Act in 2016. According to FDA cumulative data as of September 30, 2025, CBER had received 388 RMAT designation requests, of which 193 were granted, 165 denied, and 14 withdrawn. These figures show one thing: RMAT is not a handful of isolated cases, but an accelerated pathway within the US regenerative medicine review system that has already accumulated considerable practical experience. In the same year, the EU’s EMA launched PRIME (PRIority MEdicines), in which the CHMP/CAT assign a rapporteur early on to provide connected services from scientific consultation and protocol assistance to accelerated assessment; in 2024 it received 58 applications and granted 15 designations.

The most worthwhile comparison for Taiwan is in fact Japan. Japan’s Sakigake designation system, launched in 2015, places “developed first in Japan,” “early clinical data showing clear efficacy,” “targeting unmet medical need,” and “priority consultation and accelerated review” into the same logic, and shortened the review timeline from 12 months to 6 months. Beginning in 2017, Sakigake was further combined with conditional approval for regenerative medicine products, forming Japan’s version of a system that pairs “front-end accelerated guidance, back-end conditional access, and then post-market data to verify efficacy and safety.” Taiwan’s current T-RMAT plus approval with conditions, though differing in institutional detail, follows a policy logic that can be compared against this. For therapies whose data sources span the US, Japan, and Europe, Taiwan’s position on this pathway is now closer to “running alongside” than to the “running behind” of the past decade.

On the ground in cross-border collaboration: why many people miss this pathway

From the perspective of cross-border collaboration, the most common problem this mechanism encounters is not a design problem, but an information gap.

Many overseas teams’ understanding of Taiwan is still stuck at “small market, review follows the US and Europe, limited incentives to enter.” But in the regenerative medicine space, Taiwan’s pace of institutional updating in recent years has actually been quite fast: the dual acts taking effect, approval with conditions coming online, the T-RMAT guidance pilot being announced, the Regenerative Medicine Review Committee and post-market management framework gradually taking shape. These changes have not yet fully translated into a shared understanding within the international industry.

Another common misjudgment is treating “Phase II plus market entry” as “lowering evidence requirements.” But in practice, the combined compliance costs during the approval-with-conditions period—the efficacy verification obligations, post-market safety surveillance, source and distribution tracking, and drug-injury relief design—are not lighter than going through full approval. The real difference of this pathway is not “cheaper,” but “saving time and letting patients in need access the therapy earlier.” For therapies in Taiwan with real patients waiting, this time difference may be the difference between whether certain patients can hold on long enough.

A third observation worth bringing to the table is that this pathway is also especially suited to therapies that have already accumulated data on East Asian populations. The reason is not that Taiwan only looks at East Asian data, but that regenerative medicine products involve immune responses, cell dynamics, long-term safety, and process differences, so whether foreign clinical data can be extrapolated to Taiwan requires more thorough explanation than for ordinary drugs. If a product already has interpretable clinical data in Japanese, Korean, Taiwanese, or other East Asian populations, it becomes easier to discuss during review “which data can be extrapolated and which data need to be reinforced.” Many therapies currently pursuing the Sakigake and conditional approval pathways in Japan happen to meet this condition.

In the course of cross-domain collaboration on the circular economy and semiconductors, I have seen several periods of “the system has already changed, but industry has not yet caught up.” Such periods usually feature two types of people: one type is bound by established impressions and keeps walking the familiar but already outdated pathway; the other type goes back to re-read the rules and adjusts their external narrative and internal timetable. The latter are often the group that enters new markets fastest in the years that follow.

Not relaxing review, but changing part of the evidence requirements to phased completion

If all you remember is “Phase II can reach market,” you will miss the other side of approval with conditions.

First, approval with conditions is valid for a maximum of five years and cannot be extended upon expiry. That is to say, this is not a transitional market-entry qualification that can be extended indefinitely; if the applicant fails to complete the subsequent verification and supplement the data needed to support full approval within the statutory period, the conditional approval cannot be maintained indefinitely.

Second, conditional approval does not mean subsequent efficacy verification is waived. By design, during the approval period the applicant must continue to conduct efficacy verification trials, or submit real-world data studies with substantial evidentiary support, and periodically submit data to the competent authority. In practice, this can often be understood as: a portion of the confirmatory evidence ordinarily expected to be completed before market entry is instead continuously supplemented after market entry—but this does not necessarily equate to the traditional, narrow sense of Phase III.

Third, the applicant cannot simply submit clinical data and be done with it. Under the conditional approval system, the applicant must also submit an efficacy verification plan, the fee and collection method, patient relief measures, and other matters designated by the competent authority. In other words, this system requires not only scientific evidence, but also financial transparency and risk-bearing arrangements for patients actually accessing the therapy.

In addition, after a regenerative medicine product obtains conditional approval, it does not thereby escape the general drug lifecycle management requirements. Based on the competent authority’s current public statements and the context of relevant regulations, obligations such as manufacturing quality, distribution management, source and distribution tracking, post-market safety surveillance, and drug-injury relief must still be implemented in tandem. This also means that for applying companies, conditional approval is not “obtain the market-entry qualification first and complete internal compliance later,” but rather requires preparing a considerable degree of quality and supply-chain management before entry.

Putting the foregoing conditions together, one can better understand the true logic of this system. Conditional approval is not “approve first and worry later,” but rather—under the premise of a specific disease, high medical need, and already preliminarily supported efficacy and safety—the competent authority trading more intensive post-market verification, risk management, and ongoing surveillance for the possibility of earlier access. For developers, this does not reduce responsibility, but rather shifts part of the responsibility from waiting before market entry into regulatory obligations that must be continuously fulfilled after market entry.

Therefore, conditional approval, Regenerative Medicine Review Committee review, the T-RMAT guidance pilot, drug-injury relief, and full-lifecycle management are not separate institutional parts, but different links supporting the same logic of accelerated access. If one sees only “can reach market earlier” while ignoring the back-end surveillance, verification, and patient-protection design, one misreads the essence of this system.

Looking at the Next Decade Through This Pathway

Article 1 approaches it from the angle of the “data interface,” arguing that complete open data does not equal usable data, paired with a four-language searchable tool page (30 major categories + ICD-10 codes + proof validity periods). Article 2 approaches it from the angle of “reimbursement uptake,” discussing how the catastrophic-illness validity-period tiering already possesses many of the elements needed for tiered reimbursement in the AI era. This article approaches it from the angle of the “market-entry pathway,” looking at how the three-layer mechanism of the Regenerative Medicine Dual Acts, approval with conditions, and T-RMAT connects regenerative medicine products with “mature Phase II evidence” into Taiwan’s market and clinical-application pathway. Laid together, these three threads show that after the Regenerative Medicine Dual Acts took effect, Taiwan is no longer merely discussing innovative therapies in the abstract, but has begun concretely building an institutional framework for evaluating conditional access for specific products. For industry, the real next step is not to debate “whether Taiwan matters” in the abstract, but to judge which product types, which evidence combinations, and which timelines can actually walk this pathway.

For the global regenerative medicine industry, whether Taiwan is worth re-evaluating in the coming years will depend on whether this system can accumulate real success cases, and whether the competent authority continues to provide predictable review interaction. For the policy and review side, institutional integrity will ultimately come back to two things: whether the safety record stays stable, and whether conditional approval can truly connect smoothly to subsequent complete evidence.

For patients and families, the true meaning of this design is time. The gap in market-entry timing for the same therapy across different countries has often been the decisive factor for fast-progressing diseases. The core value of the three-layer mechanism of the Regenerative Medicine Dual Acts, approval with conditions, and T-RMAT is precisely to release part of that time gap earlier, by means of “post-market verification + risk management + patient relief.” For some patients, this is not merely policy progress, but the very possibility of “whether they can hold on long enough.”

For those working in cross-border collaboration, this pathway also offers a new starting point for conversation. Over the past decade and more, Taiwan-Japan collaboration has mostly centered on electronics, semiconductors, and circular materials. After the Regenerative Medicine Dual Acts took effect, Taiwan and Japan now share one more topic worth discussing: whether Japan’s years of accumulated Sakigake and conditional-approval experience and Taiwan’s newly launched approval with conditions and T-RMAT can form an operable connecting pathway in actual cases. This is one of the directions this series will continue to watch.

The next article can go further from the angle of data extrapolation, discussing bridging data under the ICH E5 framework, definitions of East Asian populations, and how—when global clinical data may directly support an application in Taiwan—the competent authority and applicants typically view population factors and the acceptability of external data. This will further connect the “market-entry pathway” discussed here to the actual technical details of an application.

Glossary

  • Regenerative Medicine Act: The law regulating medical institutions’ execution of cell therapy techniques; enacted and promulgated in June 2024, effective January 1, 2026. It governs the “medical side.” For a detailed introduction, see Article 1’s glossary.
  • Regenerative Medicine Products Act: The law regulating pharmaceutical companies’ development, manufacturing, and marketing of regenerative medicine products (including cell therapy drugs); enacted and promulgated in June 2024, effective January 1, 2026. It governs the “manufacturer side.” The two laws together are called the “Regenerative Medicine Dual Acts.”
  • Approval with Conditions (Conditional Approval, also referred to in this article as conditional approval): Under Article 9 of the Regenerative Medicine Products Act, for regenerative medicine products meeting “life-threatening or seriously debilitating disease,” “completed Phase II human trials,” and “data submitted by the applicant reviewed as having safety and preliminary efficacy and approved by the Regenerative Medicine Review Committee,” a conditional approval not exceeding five years and non-extendable may be granted.
  • T-RMAT (Taiwan Regenerative Medicine Advanced Therapy Pilot): A regenerative medicine product guidance pilot announced and advanced by the TFDA and the CDE in March 2026, focused on pre-submission regulatory and scientific consultation, review preparation, and increased communication density. Publicly stated target review timelines are 120 days for a BLA (including approval with conditions) and 15 days for an IND; actual case outcomes still depend on data completeness. The naming logic aligns with the US FDA’s RMAT designation.
  • Regenerative Medicine Review Committee: The review body established under the Regenerative Medicine Products Act, responsible for reviewing major matters such as approval with conditions and efficacy verification plans.
  • FDA RMAT (Regenerative Medicine Advanced Therapy Designation): The US FDA’s regenerative medicine accelerated pathway operating since the passage of the 21st Century Cures Act in 2016, providing support such as accelerated approval, rolling review, and close interaction for cell therapy, tissue engineering, and gene therapy products that treat serious or life-threatening diseases and whose preliminary clinical evidence indicates they can address unmet medical need.
  • EMA PRIME (PRIority MEdicines): The European Medicines Agency’s priority medicines scheme operating since March 2016, providing support such as early CHMP/CAT rapporteur assignment, iterative scientific consultation, and accelerated assessment.
  • PMDA Sakigake: The “Sakigake (さきがけ)” designation system operated by Japan’s Ministry of Health, Labour and Welfare since 2015, a pioneer review system worth comparing against. It provides accelerated review for medical products developed first in Japan whose early data show clear efficacy, and since 2017 has been further combined with conditional approval for regenerative medicine products, forming Japan’s version of a two-layer “accelerated design + early access” architecture.
  • ICH E5: The International Council for Harmonisation guideline on ethnic factors and the acceptability of foreign clinical data; the foundational framework for bridging-data argumentation. The next article will explore this in depth.
  • PIC/S GMP: Good Manufacturing Practice for pharmaceuticals.
  • GDP (Good Distribution Practice): Good Distribution Practice for pharmaceuticals.
  • RWD (Real-World Data): Health-related data collected in routine clinical settings—such as electronic medical records, health insurance data, registry databases, and patient-reported outcomes—that can be used to support efficacy verification during the approval-with-conditions period.

Note: This article is a compilation of public information and institutional observation, and does not constitute medical, legal, investment, clinical-trial-design, or pharmaceutical-application advice. Whether an individual product qualifies for approval with conditions, is suitable to enter T-RMAT, or whether its overseas clinical data can be accepted, should still be based on the latest announcements of the Ministry of Health and Welfare’s Food and Drug Administration and the Center for Drug Evaluation, as well as the Regenerative Medicine Act, the Regenerative Medicine Products Act, and related subsidiary regulations.

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