EMA Nitrosamine Q&A Rev14 published

The latest Q&A includes new Q&A 22 on approach to control presence of N-nitrosamine
exceeding the AI while CAPAs are being implemented. LTL approach is applicable to avoid supply disruptions during CAPA implementation. Please check the details.


Thanks for sharing…
This is really surprising that, within a month Q&A published documents 2 times revised.

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I share the link to a good youtube video about the LTL approach for nitrosamines. The video is fun and informative for us. Thank you for uploading, @fernandaw.


The word “limit” inside the red box means interim limit or AI?

And could you please give some advices about how to determine the treatment duration of a drug? According to my current undersanding, many drugs is impossible to be taken for a lifetime, such as antibiotic. Does such drug can be justified as a LTL used drug?

The limit refers to interim AI (corrected), which has to be derived from established AI.

Even though it is general perception that antibiotics meant for short-duration. There could be cases where the antibiotics are used for long term pertinently for recurring infections. In that case it is always preferred to consider worst case for the safety of the patient.

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Hi, @Pradpharma,

The limit will likely mean the interim limit if it is similar to LTL in ICH M7. After the determination of AI, the interim limit can be applied for up to 3 years during CAPAs, I think.

Agree @Yosukemino . I have corrected my response above

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