Taiwan’s Food and Drug Administration (TFDA), an agency of the Ministry of Health and Welfare, is the regulator responsible for authorizing investigational drug and biologic clinical trials conducted on the island. TFDA relies on the Center for Drug Evaluation (CDE) to carry out much of the scientific and technical review of a trial protocol, so a sponsor’s practical point of contact for dossier questions is often CDE even though TFDA issues the formal authorization. For a sponsor already familiar with the U.S. Investigational New Drug (IND) model, TFDA clinical trial protocol approval is the closest functional equivalent in Taiwan, and it sits alongside a separate, genuinely useful option for genuinely multiregional trials: an accelerated review track, commonly referred to in industry and regulatory-affairs literature as a Multinational Clinical Trial Notification or CTN pathway.
This guide covers what TFDA and CDE do and how the standard IND-equivalent process works, what CASRAI could and could not independently verify about review timelines, what the multinational fast-track option is (and where the specific numbers commonly quoted for it come from), the separate ethics-review requirement, and how Taiwan’s pathway compares to other Asia-Pacific regulators CASRAI has already covered.
What TFDA and CDE each do
TFDA is the statutory regulatory authority: it issues the formal clinical trial authorization, sets the applicable notices and fee schedules, and is the body a sponsor’s authorization ultimately comes from. CDE is a separate technical-review body that TFDA relies on for the scientific evaluation of a submitted dossier — chemistry, manufacturing, and controls (CMC) data, non-clinical pharmacology/toxicology data, and the clinical protocol itself — and CDE also operates a pre-submission Review Related Consultation (RRC) service that lets a sponsor discuss protocol design or dossier scope with reviewers before formally filing, similar in purpose to pre-IND meetings with other regulators. A sponsor must be either a pharmaceutical firm or a teaching hospital jointly qualified by the Ministry of Health and Welfare and the Ministry of Education; principal investigators, co-investigators, and trial personnel must be qualified by training and must conduct the trial to Good Clinical Practice (GCP) standards.
The standard IND application process
Applications are filed through TFDA/CDE’s online submission channel and must include the documentation specified in TFDA’s own “Notices for Clinical Trial Application,” along with the applicable review fee under TFDA’s published fee schedule for drug registration and trial review. CDE’s published guidance on protocol review confirms one specific, concrete procedural deadline sponsors should plan around: if CDE issues a deficiency notice during review, the sponsor’s response — supplements or amendments addressing the deficiency — is due no later than 14 calendar days after receipt, with no extension available; failing to respond in that window allows TFDA to decide the application based on the information already on file. Sponsors should treat the current fee amounts and the full current document checklist as items to confirm directly against TFDA’s and CDE’s own published notices at the time of filing, since both are revised periodically and CASRAI is not treating any third-party-quoted fee figure as authoritative here.
How long standard review actually takes
This is one area where CASRAI wants to be explicit about the limits of what’s verifiable from TFDA’s own English-language materials versus what circulates in secondary industry sources. Third-party regulatory-affairs and CRO publications describe standard TFDA IND review timelines that vary depending on how the clock is anchored — figures in roughly the 30-to-60-calendar-day range appear across different sources, with some measuring from a complete technical dossier and others measuring from a separate ethics-committee milestone. CASRAI was not able to confirm a single, TFDA-sourced total review-time figure that reconciles these variants, so treat any specific day count you see quoted by a CRO or consultancy as a planning estimate rather than a regulatory commitment, and confirm the current expected timeline directly with TFDA, CDE, or Taiwan-based regulatory counsel before building it into a submission plan.
The multinational fast-track (“CTN”) pathway
The core claim behind a “Multinational CTN Fast Track” is real, but it’s worth being precise about what CASRAI could confirm directly from TFDA versus what is reported by industry sources without a primary citation CASRAI could independently verify.
TFDA’s own English-language announcement of clinical-trial-review enhancement measures (dated 2017) establishes an accelerated review option for trials that are genuinely multiregional — specifically, “multiregional and non-first-in-human clinical trials conducted in both one of the ten medical-advanced countries and Taiwan,” alongside a separate track for investigator-initiated academic trials using products already tested domestically. That announcement’s own headline figure (30 days) is scoped to the cell- and gene-therapy trials it specifically covers, not to IND review generally, and TFDA has stated it continues to revise these measures over time — so treat 2017 as the origin of the mechanism, not necessarily its current parameters.
Separately, multiple industry and CRO publications describe a broader, general-drug version of this idea — usually labeled a Multinational Clinical Trial Notification (CTN) scheme — under which a sponsor who is filing the same protocol in parallel with a recognized reference regulator (most often cited as the U.S. FDA or EMA) can qualify for administrative-track review at TFDA rather than full technical re-review, with several sources citing review times as short as roughly two weeks against a standard review measured in multiple weeks, and describing CTN filings as now a substantial share of Taiwan’s total IND volume. CASRAI could not trace the specific “14 days” figure, the exact qualifying reference-country list, or the “administrative review only” characterization to a primary TFDA/CDE publication independently of these secondary sources, so present them here as industry-reported rather than confirmed, and recommend any sponsor relying on this pathway for a submission timeline confirm the current eligibility criteria, qualifying countries, and expected review period directly with TFDA or CDE. The list of qualifying reference jurisdictions is itself reported inconsistently across sources — some describe it narrowly (U.S. FDA, EMA), others describe a broader ten-country list (commonly reported as including the United States, the United Kingdom, Germany, France, Japan, Switzerland, Canada, Australia, Sweden, and Belgium) — which is another reason to verify current eligibility directly rather than rely on any single secondary source.
Ethics review: a separate, parallel requirement
TFDA/CDE authorization does not, on its own, permit a trial to enroll subjects. Taiwan requires independent ethics review and approval at the institutional level — functionally equivalent to Institutional Review Board (IRB) review in the U.S. model — before the first subject can be enrolled at a given site, following the pattern common across the Asia-Pacific pathways CASRAI has covered elsewhere (see the Korea and Thailand comparisons below). As with those jurisdictions, sponsors should plan the site-level ethics review and the TFDA/CDE technical review as parallel, independent tracks rather than assuming one gates the other in a strict sequence, and should confirm current site-level requirements with each participating institution.
How Taiwan compares to other pathways CASRAI has covered
- South Korea (MFDS): see CASRAI’s MFDS Clinical Trial Approval guide — a 30-working-day default implicit-clearance model for the Clinical Trial Plan (CTP), Korea’s IND equivalent, with its own pre-submission consultation option.
- Japan (PMDA): see CASRAI’s PMDA Clinical Trial Notification (CTN) entry — Japan’s own use of the term “CTN” refers to its domestic notification-based system, distinct from Taiwan’s multinational fast-track despite the similar acronym; don’t conflate the two when comparing jurisdictions.
- China (NMPA): see CASRAI’s NMPA Clinical Trial Approval Process guide for China’s considerably longer default review track and its own expedited option for qualifying innovative drugs.
- Singapore (HSA): see CASRAI’s HSA Clinical Trial Pathways guide — Singapore also uses “CTN” as a defined term within its own CTA/CTN/CTC framework, again a different mechanism from Taiwan’s multinational fast track despite the shared abbreviation.
- Thailand (Thai FDA): see CASRAI’s Thailand Clinical Trial Approval guide for a regional comparison with a distinct ethics-committee structure.
- Vietnam and the Philippines: see CASRAI’s Vietnam DAV/MOH pathway guide and Philippines FDA pathway guide for two more Southeast Asian comparison points.
- Cross-jurisdiction dossier design: sponsors coordinating a trial spanning Taiwan alongside other regions should also read CASRAI’s coverage of ICH M11, the harmonized clinical trial protocol template increasingly used to reduce region-by-region protocol rework, and the underlying ICH E6(R2) GCP standard that Taiwan’s own GCP requirement is aligned with.
Worth flagging explicitly: “CTN” is used as a defined term by at least three different Asia-Pacific regulators covered on this site — Taiwan’s TFDA (multinational fast-track notification), Japan’s PMDA (its standard domestic Clinical Trial Notification system), and Singapore’s HSA (one leg of its CTA/CTN/CTC framework) — and none of the three mechanisms work the same way. A sponsor’s regulatory affairs team should never assume a “CTN” process description written for one of these jurisdictions transfers to another.
Who manages this process
In practice, the TFDA/CDE submission is typically owned by a sponsor’s Taiwan regulatory affairs function or a Taiwan-based CRO acting on the sponsor’s behalf, coordinating with the participating institution’s own ethics review body and, where the trial qualifies, assembling the parallel-filing evidence (protocol identity, submission dates, and status with the reference regulator) needed to support a multinational fast-track request. For a multinational sponsor’s research administration office, the practical value of this guide is knowing which questions to put to Taiwan regulatory counsel or a local CRO early — current fee amounts, the current qualifying-country list for fast-track eligibility, and a realistic (not vendor-quoted) review-timeline estimate — rather than treating any single third-party figure as a committed date.
Frequently asked questions
Is a TFDA clinical trial authorization the same as an FDA IND?
Functionally comparable — both are the required regulatory authorization before an investigational drug or biologic can be administered to human subjects in that jurisdiction, and TFDA relies on CDE for much of the underlying technical review the way FDA relies on its own review divisions. The specific review-timeline mechanics differ and, as covered above, CASRAI could not confirm a single authoritative TFDA total-timeline figure to cite directly against the FDA’s 30-calendar-day standard.
How long does TFDA review actually take?
Reported figures vary by source and by how the clock is anchored, generally somewhere in the range of roughly 30 to 60 calendar days for standard review. CASRAI could not confirm one authoritative figure directly from TFDA’s own materials, so confirm the current expected timeline with TFDA, CDE, or local regulatory counsel rather than relying on any single third-party estimate.
What is the Multinational CTN Fast Track, exactly?
It’s a real accelerated review option for genuinely multiregional trials — TFDA’s own 2017 enhancement-measures announcement confirms an accelerated track tied to a trial running in both Taiwan and one of a defined set of other countries, though that announcement’s specific figures are scoped to cell- and gene-therapy trials. A broader version covering general drug INDs, often described in industry sources as reducing review to as little as roughly two weeks when the protocol is filed in parallel with a reference regulator such as the U.S. FDA or EMA, is widely reported but not something CASRAI could independently confirm word-for-word against a primary TFDA source — verify current eligibility and timeline directly with TFDA/CDE before relying on it.
Do I still need separate ethics committee approval?
Yes. TFDA/CDE authorization and site-level ethics review are independent requirements, and both must be satisfied before a site can enroll its first subject — this is the same pattern as in Korea, Japan, and the other Asia-Pacific pathways CASRAI has covered.
Who is eligible to apply for a Taiwan clinical trial authorization?
The applicant must be a pharmaceutical firm or a teaching hospital jointly qualified by Taiwan’s Ministry of Health and Welfare and Ministry of Education; investigators and trial personnel must meet GCP training and qualification requirements.
Key takeaways
- TFDA is Taiwan’s clinical trial regulator; CDE performs much of the technical review on TFDA’s behalf and also offers a pre-submission consultation (RRC) service.
- Applicants must be a pharmaceutical firm or an MOHW/MOE-qualified teaching hospital, with GCP-qualified investigators and trial personnel.
- A confirmed, specific procedural deadline: deficiency-notice responses are due within 14 calendar days, with no extension available.
- Overall standard review-timeline figures vary across third-party sources (roughly 30-60 calendar days) and CASRAI could not confirm one authoritative TFDA-sourced total — verify directly before planning around any single quoted number.
- A real multinational fast-track mechanism exists, confirmed via TFDA’s own 2017 enhancement-measures announcement for multiregional trials run alongside a defined set of other countries; the widely-reported ~14-day figure and full current eligibility criteria for the general-drug version could not be independently confirmed from a primary TFDA source and should be verified directly.
- Site-level ethics review is a separate, mandatory requirement independent of TFDA/CDE authorization.
- “CTN” means three different things at TFDA, PMDA, and HSA respectively — don’t assume a process described for one transfers to another.
