Notice: Full Implementation of Online Application for Drug Clinical Trial Cases

To enhance the efficiency of submission and review of drug clinical trial cases in Taiwan, the Drug Registration Review and Online Application Platform (ExPRESS) has fully implemented online application for the following cases:

1. Multinational, multicenter clinical trial cases (including new applications, amendments, and final reports).
2. Clinical trial inquiry cases.
3. General clinical trial review cases (including Fast Track review, new applications, amendments, and final reports).
4. Bioavailability/Bioequivalence (BA/BE) and in vitro comparison test cases (including new applications, amendments, and final reports).
5. Bridging study (BSE) cases.
6. Cell therapy product clinical trial cases (including new applications, amendments, and final reports).
7. Gene therapy product clinical trial cases (including new applications, amendments, and final reports).

Important Timeline

Starting January 1, 2026 (Year 115), all applications for the import/export of investigational drugs under clinical trial plans must be submitted online only. Paper submissions will no longer be accepted.

Recommendations

• Companies holding a business certificate are encouraged to apply for the MOEA Electronic Official Document Exchange Service to expedite document transmission.
• For the online application portal and user manual, please visit: http://e-sub.fda.gov.tw/dohclient/Login.aspx.