AI for NDSRI by Brazil regulatory

Guidance, Documents, Resources
1

Is there any update guidance available of Brazil regulatory for AI for NDSRI ?

2

Hello Mahendra!
To date, we have not had any updates on current legislation or guidance on N-nitrosamines. As it’s ICH member and has an agreement with the EMA, the limits adopted here in Brazil for “known” nitrosamines and, even for NDSRIs, are in line with what we already know internationally.
In the case of NDSRIs, the limits already set out in the EMA guidance and appendix can be used. If the new nitrosamine is not yet included, the ANVISA guide contains the following passage in item C of section 8:
“During the risk assessment there is still the possibility of other nitrosamines, potential or real, being found, in addition to those listed in Table 3. Given the absence of specific limits, a similar approach to that previously carried out for nitrosamines with limits listed in this guide is recommended, with the determination of a specific limit based on carcinogenicity studies, when available. In cases where carcinogenicity studies are not available, it is recommended to derive a limit from a comparison of the Structure Activity Relationship (SAR) with known nitrosamines or to apply a specific TTC for the class of nitrosamines.”
Hope this help.

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3

@CesarJr Thanks for the reply. Do we know if ANVISA is looking to update soon the current Nitrosamines Guideline?

4

Hi @Naiffer_Host!

I have been at the last meeting of the Brazilian Pharmacopoeia in November/2023.
There, was discussed about the nitrosamines and the issue of its being included in the Brazilian Pharmacopoeia. The issue of regulatory updates was addressed too.
According ANVISA itself, the updates from other agencies are being followed up (mainly EMA) and an update of the Guide n° 50 would soon be published (we were told it was in the pipeline), however we have not had a forecast with dates.
The last guide edition is version 3 of June/2023.

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Thanks Cesar… It would be interesting to learn what Brazilian Pharmacopoeia is thinking on addressing Nitrosamines Impurities.
I recently participated in the compedial discussion between USP, EP, JP, IPC part of Pharmacopeial Discussion Group. We learned a lot from our EP’s colleagues on their compendial journey to address Nitrosamines.

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6

Hii,

ANVIA has published Guide on Nitrosamine Control in Active Pharmaceutical Ingredients and Medicines Guide no 50/2021 – version 4 on 31/07/2024 and valid from 01/08/2024.
May be useful to you so plz find attached.

Regards,

JIGAR SHAH
ANVISA.pdf (2.8 MB)

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7

Dear All,

Thanks a lot dear.

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