Please refer to the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products” announced by the TFDA.

1. The sponsors may consult with CDE (Center for Drug Evaluation) for pre-IND consultation before the formal IND submission to TFDA or submit IND application to TFDA directly.
2. Before submission, the applicant has to complete the registration process on the Clinical Trials Network in Taiwan website and shall mail the hardcopies to the TFDA within 7 days to complete the application procedure.
3. According to the “Review Processing and Timeline for clinical trial” announced by the TFDA, the review time is summarized in the following table: 

   Review process	Review time(calendar days)
   Fast Track for Cell/Gene Therapy Product IND	30 days
   Standard Review for Cell/Gene Therapy Product IND	45 days
   Complex Review Process for Cell/Gene Therapy Product IND	150 days

(中文版)