🇧🇷 Guideline for the control of Nitrosamines Rev. 4

Guidance, Documents, Resources
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@trust_user_a @trust_user_b @trust_user_b @trust_user_c

Happy Friday.
Christmas in August!! Yesterday Mexico, today, ANVISA. Brazil’s national regulatory body published a revision of its nitrosamine guideline, “Guia sobre o Controle de Nitrosaminas em Insumos Farmacêuticos Ativos e Medicamentos,” Version 4.

Anvisa Nitrosamine guideline V4.pdf (1.6 MB)

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Visit the community for in-depth discussion and access to non-official translations of the guideline.

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Non-official translations (Google Translation)

Ensligh:
Anvisa Nitrosamine guideline V4 English.pdf (2.8 MB)

Spanish:
Anvisa Nitrosamine guideline V4 Spanish.pdf (2.8 MB)

German:
Anvisa Nitrosamine guideline V4 German.pdf (2.8 MB)

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I was just going to publish the new version you beat me this time :smiley: . It is going to be a busy month!

I will edit my post with my insights on the new version when I finish going through it.

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Thank you for sharing
Much appreciated

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Certainly, this is good news.

It is highly significant to witness our agency’s position on this matter and its endorsement of the CPCA calculation and the Enhanced Ames assay test.

Great job, ANVISA!

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Thank you for sharing :slight_smile:
Muito obrigada!!

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Your outstanding work is truly appreciated. We are grateful for your unwavering support and the invaluable information you provide.

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Dear Naiffer, Thanks for sharing ANVISA Nitrosamine guideline

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Thanks for sharing the guidance. The acceptable intake mentioned by ANVISA is NDMA: 9601 ng/day, MeNP: 40010 ng/day. However, in other guidelines, NDMA is 96 ng/day and MeNP is 400 ng/day.

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Check the original documents when reviewing the translation. Those additional numbers are the footnotes. Be careful!

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Thanks for observation.

As per the original documents, NDMA is 96.0 ng/day and MeNP 400 ng/day.

During translation, superscript is converted into the value. Please refer original.

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Yes Naiffer Noted and thanks for same

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Ok Dinkar thanks for same

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01 and 10 are the references to these values. I have checked all values and are inline with other regulators

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Thanks for sharing this guideline. Can anyone compile the difference between version 3 vs version 4

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@Naiffer_Host thx again for sharing ¡!

Do you (or any one else) know if there is “public” accessible link from ANVISA already available?
I was not able to find it (in ANVISA web´s page v03 still appearing and links pertained to update up to v04 requires login)

Regards,
Estefy

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556594c5-4764-417a-9fb2-c06d299a02a4 (anvisa.gov.br) is what gives version 4 for me without login.

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Gracias! que buena quincena!!!
MĂ©xico y luego Brasil!

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Dear @Naiffer_Host thank you for sharing about the update!

It caught my attention that the limit for NMPA is 34,3 ng/d, based on the harmonic mean of results published in Carcinogenicity Potency Database. Meanwhile the EMA limit for NMPA is 100 ng/d. EMA’s appendix 1 does not provide any explanation but the limit is consistent with CPCA (0+3 hydrogens, no other features).

Do you think EMA may tighten the limit for NMPA, taking into account that 34,3 ng/d is grounded in experimental results?

Best regards,
Marcin

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