FAQ
Drugs

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be submitted for the stability testing section?

刊登日期:2021-11-17  |  點閱次數 : 377 次 

During the RTF stage, stability testing results for at least three pilot-scale API batches should be provided. These should include 6 months of accelerated stability testing results and 6 months of long-term stability testing results. If the long-term stability testing results covers the re-test period of API, based on “Guidance on Drug Product Stability Testing”, accelerated stability testing results may be waived.

 

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