Taiwan pairs prior TFDA approval for Phase I to III trials with hospital IRB review and a joint IRB system for multicentre studies. Capture keeps Taiwanese sites in one study with a field-level audit trail, and you can build and test it free first.
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Study region
Taiwan
Key points for studies in Taiwan
Regulation
In Taiwan the sponsor applies to the TFDA for trial approval and, at the same time or soon after, applies to the IRB at each site. Industry summaries describe the standard initial IND review as taking in the order of 45 calendar days and describe a faster pathway for multinational trials whose protocol has also been filed with a major regulator such as the US FDA or EMA. A guide that repeats these figures adds that it could not verify the timelines, so treat them as planning assumptions only and ask the TFDA or your Taiwanese CRO for the current service standards.
The IRB application is normally prepared by the sponsor or CRO and filed in the name of the investigator. For a multicentre study the joint IRB system lets one main-review IRB carry the substantive review while participating hospitals use a sub-review IRB for local matters, and one source quotes about 20 working days for the main review. Which hospitals sit in which category, and how your sites fit, is a question for the research office at each hospital.
Two practical consequences for the data system. First, the sponsor needs a precise description of what will be collected, ideally the blank eCRF set. Capture exports every approved form printed empty with a cover page, form index and visit-by-form matrix. Second, a multicentre IRB will ask about monitoring, query handling and who can edit data. Role-based access, auto-queries and a field-level audit trail answer those in one place. See query management software for clinical trials.
Medical device studies and low-risk research follow different TFDA and ministry rules and often skip the IND route. They still need IRB review under the Human Subjects Research Act. Ask the IRB at the start which route your study follows. For device work see EDC for medical device clinical trials.
| TFDA / CDE | Main-review IRB | Sub-review IRB | Hospital contract | |
|---|---|---|---|---|
| Reviews protocol and product data | ||||
| Reviews consent form | ||||
| Local investigator and facility | ||||
| Budget and indemnity | ||||
| Can run in parallel with TFDA | n/a |
Terms
| Term | Meaning | Why it matters for data |
|---|---|---|
| TFDA | Taiwan Food and Drug Administration, under the Ministry of Health and Welfare. | Approves the trial application and can inspect trial sites and records. |
| CDE | Center for Drug Evaluation, which does much of the technical review for the TFDA. | Questions on the protocol and data collection often come from here. |
| IND | Investigational new drug application, here the trial approval request. | Needs protocol, product and safety data before enrolment. |
| IRB | Institutional review board at each hospital. | Approves consent and the study at each site; the audit trail supports follow-up. |
| JIRB | Joint IRB system for multicentre trials, with main- and sub-review IRBs. | Concentrates review but each site still has local steps. |
| PDPA | Personal Data Protection Act. | Governs collection, use and transfer of personal data, including health data. |
Data protection
Taiwan generally allows cross-border transmission of personal data. Article 21 of the PDPA lets the central competent authority for an industry restrict it in defined cases: national interest, a treaty requirement, inadequate protection in the destination country, or a transfer arranged to avoid the Act. Sources say there is no single data protection authority and that each industry authority handles oversight, although a dedicated commission was expected and its status should be checked. They also report that some sector regulators have restricted transfers to mainland China.
Medical records and health examination data are among the special categories the PDPA treats more strictly, with exceptions that include some academic and statistical research. We did not retrieve the exact article wording, so do not assume a research exception covers your use. Ask Taiwanese counsel about the lawful basis, whether participant consent should name cross-border processing, and whether the health authority has guidance for trial data.
Capture hosts in the EU (Frankfurt) and the USA (N. Virginia), not in Taiwan. In practice, name the hosting regions in the consent form and the clinical trial agreement. Site coordinators see participant names while researchers see coded IDs, enforced by row-level security, and data is encrypted at rest (AES-256) and in transit (TLS). See GDPR compliant clinical trial software for the transfer principles many sponsors apply.
Create several site accounts, enter sample data and check site-level exports in the free sandbox.
Multicentre
Each site gets a coordinator portal, site-level participant numbering such as 001-0042, and data filtered by site. Enrolment can use site-specific QR codes with no app install for participants. Approved forms are locked, so every hospital uses the same version, and an amendment moves all sites together.
Randomized
166 / 240
Open queries
24
Fields verified
84%
3 open queries · 92% SDV
7 open queries · 85% SDV
14 open queries · 61% SDV
0 open queries · 100% SDV
Site risk
Site 03 query backlog
Data lock
Site 04 ready to lock
Typical start-up
A sketch for planning, not a regulatory timeline.
Ask the lead hospital whether the joint IRB system applies and which IRB is the main reviewer.
Protocol, investigator brochure, consent materials, site information and the blank eCRF PDF.
Submit in parallel where allowed, with your Taiwanese representative or CRO.
Hospital agreements, indemnity and the PDPA transfer wording for EU or US hosting.
Create site accounts, train coordinators and enrol after approvals are on file.
Taiwanese research
Taiwan has a dense network of academic medical centres, a strong health information infrastructure and an active biotech and device sector, which is why it features in many Asia-Pacific programmes next to Japan, South Korea and Singapore. Sponsors also run investigator-initiated studies and registries from the major hospitals, and many of these teams do not want a heavyweight vendor project.
For those studies Capture offers a self-serve route: build the study, test it free and go live without a sales call. See EDC for investigator-initiated trials and clinical trial software without a CRO. For regional context read the Japan and Hong Kong guides, and the China page if mainland sites or data are involved.
Before you start
IND, device or other pathway, and any fast-track eligibility, checked with the TFDA.
Joint IRB or individual hospital IRBs, with the main reviewer named.
Approved Traditional Chinese consent and participant information prepared by your team.
Lawful basis and transfer wording for EU or US hosting, checked with counsel.
Decision on whether mainland sites or data are involved and which rules apply.
Coordinator and investigator accounts matched to the delegation log.
The TFDA, under the Ministry of Health and Welfare, approves drug trials, with the Center for Drug Evaluation doing much of the technical review. IRBs approve the study at each site. Confirm the current process with the TFDA.
Sources say IRB review can run in parallel with the TFDA application. Trial start requires both. Check with the TFDA and your IRB.
A system for multicentre trials in which a main-review IRB carries the substantive review and other participating hospitals use sub-review IRBs. Ask your lead hospital how it applies to your study.
The Personal Data Protection Act. Article 21 lets industry authorities restrict cross-border transfers in certain cases. How it applies to trial data should be checked with Taiwanese counsel.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Name the hosting regions in consent and contracts.
No. Capture is self-serve. Your team or your CRO builds and runs the study in the platform.
No regulator approves EDC software. Capture provides an audit trail, e-signatures and access controls. Your validated use is what regulators assess.
Yes. The free sandbox has every feature, with no credit card and no time limit.
Keep exploring
Clinical trial software in China
NMPA, HGR and data export.
Clinical trial software in Hong Kong
Drug Office certificate and PDPO.
Clinical trial software in Japan
PMDA and J-GCP.
Query management software
Auto-queries and resolution.
EDC for medical device trials
Device studies without drug import.
Multi-site trial management
Site-level numbering and exports.
Same forms, checks and audit trail at every hospital. Free sandbox.