FAQ
Drugs

On the API Registration and DMF Refuse to File (RTF) checklist, with regards to item 7 on the Type III checklist which states “Are drug substance and intermediate specifications, analytical procedures and certificates of analysis provided?”, what information should be provided?

刊登日期:2021-11-17  |  點閱次數 : 211 次 

For the drug substance part, drug substance specification, detailed description of the in-house analytical procedures and batch analysis results for one drug substance batch should be provided. For intermediates, if an intermediate can be isolated, then the intermediate specification, analytical procedures and in-house analysis results should be provided.

 

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