Clinical trial application to the authority in Taiwan

For conducting clinical trials of pharmaceuticals or medical devices in Taiwan, it is necessary to submit the application to the Taiwan Food and Drug Administration (TFDA) except those classified as having no significant risk. In addition to TFDA approval, the clinical trial must also be submitted to the Institutional Review Board (IRB) of the trial institution. Clinical trials can only proceed after completing these submissions.

TFDA review focuses on aspects such as trial design and feasibility and authorizes the Center for Drug Evaluation (CDE), a non-profit organization, to conduct technical data review. Sponsors need to submit applications for clinical trial protocol review to TFDA and related documents, the process as shown in the figure:

Upon completion of the clinical trial, it needs to notified the authority , and a final report must be submitted for reference.

The TALENT team has extensive experience in conducting and managing clinical trials. We can provide clients with a complete trial management team and assist them in submission and responding. If you have any related needs or inquiries, please feel free to contact us.

Reference
1. Taiwan Food Drug Administration
2. Taiwan Clinical Trials: https://www.taiwanclinicaltrials.tw/en
3. Center for Drug Evaluation, Taiwan: https://www.cde.org.tw/eng/