This message was posted by a user wishing to remain anonymous
Hi Narra,
Thank you so much for the reply.
The wordings in Q1E have no ambiguity: if you have 6-month accelerated data and 1.5 year LT, you get 2.5 years of shelf-life. The emphasis on "up to 24 months" in the Q&A document, on the other hand, is confusing to me. A colleague of mine indicated that 2x shelf-life is granted, up to 24 months, even in the absence of EITHER accelerated data or statistical analysis. I wanted to know if this is other people's experience too. If the ANDA sponsor uses the RLD as supporting data, I can see 1.5x as reasonable, but not 2x.
A related question: if the agency grants 2x the LT, up to 24 months, as a blank check, it applies to ANDA only?
OP
Original Message:
Sent: 13-Dec-2022 21:54
From: NARRA NAGA PAVAN KUMAR
Subject: Inconsistency between FDA's Q&A and ICH Q1E ?
- Of course the guidance document guide us to understand the data required for the submission , but how ever the decision is solely depended on the regulatory agency based on the case on to case submissions/review depending on molecule behavior. regarding the data requirement for submission when we consider NDA where in most of the cases the LT 12 months stability data and 6 months accelerated data is readily available at the time of IND submission 6 months LT data is required. where as in case of ANDA as per my knowledge and flow of the submissions considered many of the ANDAs are submitted with 6 months LT data and many if them got approved.
- According to the ICH Q1E Granting 2x shelf life time can be from either accelerated or LT. It gives more confident to the auditor if both the data is available, how ever it is not a requirement of having both, statistical analysis from one accelerated or LT is sufficient for the extrapolation of shelf life. how ever real time is required to support this. If any discrepancies observed in the LT testing of proposed(extrapolated) shelf life, The batch has to be recalled immediately up on the observation.
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NARRA NAGA PAVAN KUMAR
Mr.
Bengaluru
India
Original Message:
Sent: 12-Dec-2022 09:18
From: Anonymous Member
Subject: Inconsistency between FDA's Q&A and ICH Q1E ?
This message was posted by a user wishing to remain anonymous
The agency states in its Q&A document on stability testing that "FDA will grant a shelf life period of two times the available long-term data at the time of approval (up to 24 months) following the recommendation of the ICH Q1E Evaluation of Stability Data (ICH Q1E) guidance, provided the submitted data are satisfactory, and data evaluation and appropriate commitments are provided in accordance with ICH Q1E. Please refer to the decision tree (Appendix A) in ICH Q1E. The ANDA should be updated with 12 months of long-term data during the review cycle"
- Q1E says 12-month long-term data are expected at submission. How likely is the agency accept 6-month LT data when the package is submitted? Does it depend on whether it is an NDA or ANDA?
- Some people interpret the above document as the FDA granting shelf-life 2x the LT data, up to 24 months, regardless of the availability of accelerated data or sound statistical analysis. Is this your understanding too?