Conducting clinical trials of pharmaceuticals or medical devices in Taiwan requires prior regulatory and ethical approval. Except for trials classified as having no significant risk, all clinical investigations must be submitted to the Taiwan Food and Drug Administration (TFDA) and the Institutional Review Board (IRB) of the participating institution. Clinical trials may commence only after both submissions have been completed and approved.

The TFDA is responsible for reviewing the trial design, feasibility, and overall compliance with regulatory requirements. The Center for Drug Evaluation (CDE), a non-profit organization authorized by the TFDA, conducts technical reviews of submitted data.

Applications must be submitted via the TFDA Online Application Platform , accompanied by the required review fee. All documents must follow the requirements outlined in the Notices for Clinical Trial Application issued by TFDA.

Review Process and Timelines for Clinical Trials

Deficiency Response and Timelines

If deficiencies are identified during review, supplements or amendments must be submitted within 14 days from the issuance of the deficiency notice. Extensions are not permitted. Failure to respond by the deadline allows the authority to reject the application based on available information.

Review Fees

Taiwan clinical research review fees vary significantly by the regulatory authority and type of application. Fees for Investigational New Drug (IND) applications to the TFDA can be TWD 60,000, while Institutional Review Board (IRB) review fees vary by institution, with examples including NT$15,000 for new applications by the Joint Institutional Review Board (JIRB). Fees also depend on whether the research is sponsored, government-backed, or an individual academic project.

  • New application for review: NT$15,000
  • Amendment applications: NT$2,500

Required Documents for Clinical Trial Protocol Applications

1. Application Documents

  • Application letter (trial details, purpose, sites, PI, study title, protocol number, participating countries, and document list)
  • Case category form & basic case information form (downloadable from TFDA website)
  • Electronic file directory (CD format)

2. Legal/Regulatory Authorizations

  • Copy of pharmaceutical license (or hospital certification / CRO authorization)
  • Ethics Committee (IRB) approval, or note on parallel submission
  • Proof of foreign market approval or foreign regulatory/ethics approval, if applicable

3. Trial Protocol Documents

  • Summary table of protocol content
  • Chinese and English abstracts of the protocol
  • Full clinical trial protocol (with version/date, signed by PI)

4. Informed Consent & Participant Materials

  • Informed consent form (with version/date, signed by PI)
  • Case Report Form (CRF)

5. Investigator Qualifications

  • CVs, academic background, publications of PI and co-investigators (signed)
  • Training records in compliance with Good Clinical Practice (GCP) and human subject protection regulations

6. Risk Management & Insurance

  • Insurance certificate and related documents for trial-related injury compensation

7. Technical & Product Documents

  • CMC, non-clinical (toxicology, pharmacokinetics), and available clinical data
  • Full toxicology and pharmacokinetics reports for first-in-human trials
  • Investigator’s Brochure (IB)
  • Validated Chinese version of Patient-Reported Outcome (PRO) questionnaires (if used as a primary endpoint)
  • Packaging and labelling materials (photos or drafts)

8. Import/Export & Logistics

  • Application forms, checklists, and supporting documents for import/export of investigational products

9. Special Procedures (If Applicable)

  • Multinational Multi-center Trials: foreign regulatory approval and undertaking form
  • Simplified Domestic New Drug Trials: undertaking form, FDA approval/protocol documents (Form FDA 1571, IND acknowledgement), and IRB letter from a U.S. hospital

10. Review Fee

  • Clinical trial protocol review fee (as listed above)

Reference:

https://www.cde.org.tw/drugen/25797/26014/26039/26041/26043/normalPost

https://www.fda.gov.tw/tc/siteContent.aspx?sid=9888

Author: 李慧婷 / Wai Theng Lee

Clinical Research Partnerships Manager