Review of Clinical Trial Protocols for New Drugs

　　　CDE　is the window of Investigational New Drug (IND) submission and is responsible for IND review. A transparent and timely process is established to enforce the quality and efficiency of IND review. Where necessary, CDE will arrange face-to-face meetings or provide teleconference with the sponsor for the IND issues. CDE completes IND review within 20 calendar days and sends the recommendation to DOH. Most of the recommendations are adopted by Bureau of Pharmaceutical Affairs (BPA) which directly issues the administrative decision. A few cases may be processed to further discussion in Drug Advisory Committee.

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