FAQ
Drugs

What CMC data of active controls or concomitant drugs should be submitted for investigational new drug (IND) applications?

刊登日期:2019-11-11  |  點閱次數 : 474 次 

If the drugs for active control/concomitant drug use have been approved for marketing in Taiwan and are made by the same manufacturer, the license number should be provided and CMC data can be waived.

If the drugs for active control/concomitant drug use have not been approved for marketing in Taiwan and have not been used in approved clinical trials in Taiwan, the CMC data of drug substance and drug product should be submitted in accordance with the provisions of the “Clinical Trial Protocol-Guidance on Technical Documents”. If the drug has been marketed in one of the A10 countries (please refer to the “Regulations for Registration of Medicinal Products”), proof of permission to market (in A10 counties), the name and address of the manufacturer of the drug product, compositions of the drug product, and certificate of analysis of the drug product should be provided.

 

(中文版)


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