FAQ
Drugs

What are the procedures for registration of clinical trials of human cellular products?

刊登日期:2019-11-11  |  點閱次數 : 860 次 

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)


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