What are the procedures for registration of clinical trials of human cellular products?
刊登日期:2019-11-11 | 點閱次數 : 1333 次
Please refer to the “Application Procedures and Review Guidelines for Clinical Trials of Human Cellular Products” announced by the TFDA.
- 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.
- 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.
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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
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