On the ANDA Refuse to File (RTF) checklist, Item 3 of annex checklist 5 states “Does the application data include synthesis steps and process flow diagrams of the manufacturing process, drug substance specification, analytical procedures and certificates of analysis?”. Is it acceptable to provide drug substance specification, analytical procedures and certificates of analysis issued from drug product manufacturer?
刊登日期：2021-11-17 | 點閱次數 : 1372 次
No, since annex checklist 5 of ANDA Refuse to File (RTF) checklist is based on MOHW no. 1071404052 announcement which allows alternative data to be provided instead of “technical documents of the drug substance”. Therefore, the information from the drug substance manufacturer should be provided instead of the information from the drug product manufacturer.
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