Dear colleagues,
I’m currently evaluating the possibility of applying the Less Than Lifetime (LTL) approach for nitrosamine risk assessment in the context of new generic product registrations. I’d be very interested to hear about your practical experiences with different agencies (EMA, FDA, TGA). Have you successfully applied the LTL approach in a new registration dossier?
Any insights or lessons learned would be greatly appreciated.
Dear RFI
Kindly as per regulator guidance and published experience as below :
1-FDA :does not accept the LTL approach for nitrosamine limits
2-EMA: has accepted LTL only as a temporary/interim measure, with strong justification and a clear plan to meet lifetime AI.
3-TGA: generally aligns with EMA — possible as an interim step, but not a permanent solution.
Conclusion : LTL can help bridge supply continuity in EMA/TGA submissions, but don’t rely on it for FDA.
see attached as per FDA As below:
https://www.fda.gov/media/141720/download?utm_source=chatgpt.com
Hi Rfl
As per my knowledge, LTL is not acceptable for US market products. However, I am having experience of LTL approach with EU region where we have communicated the proposal for one of the product with LTL approach & received the positive response from agency.
In my experience LTL in this point in time, it is a ‘tool’ that CAN only be leveraged by the regulatory authority for a particular drug to prevent shortage. There are clear discussion under M7 to evaluate the considerations in the future, but at the moment is not accepted by manufacturing for proposing a higher limit.
-Naiffer
My experience with EMA has been that LTL has not been accepted for products not already in the market. I believe the question in the Q&A explicitly says it does not apply for new/ongoing applications
has anyone experience with negative EAT and LTL? is this applicable? is this acceptable by EU reg bodies?