This morning COFEPRIS published their Nitrosamines Guideline “GUÍA PARA LA VALORACIÓN, MANEJO Y MITIGACIÓN DE RIESGOS POR LA PRESENCIA DE IMPUREZAS DE NITROSAMINAS EN FÁRMACOS Y MEDICAMENTOS EN MÉXICO”
Official Guide: https://www.gob.mx/cms/uploads/attachment/file/934527/Gu_a_Nitrosaminas_Versi_n_Final_20240724.pdf
@LATAM_Community No se querrán perder esta actualización que se publico hoy desde COFEPRIS Mexico!! Todos sus comentario y perspectivas son bienvenidas!
@Naiffer_Host - do you have an English version at all please?
@trust_user_a @trust_user_b @trust_user_c @trust_user_d
This morning COFEPRIS (Mexico) published their Nitrosamines Guideline “GUÍA PARA LA VALORACIÓN, MANEJO Y MITIGACIÓN DE RIESGOS POR LA PRESENCIA DE IMPUREZAS DE NITROSAMINAS EN FÁRMACOS Y MEDICAMENTOS EN MÉXICO”
You can access the guide and dive deep into its details right here in the Nitrosamines Exchange community. For global reach, please feel free to forward this notice to your regulatory affairs colleagues.
-Naiffer Romero
USP
Using Google translation:
-English:
COFEPRIS_Guia_Nitrosaminas_Version_Final_20240724 English.pdf (1.7 MB)
German:
COFEPRIS_Guia_Nitrosaminas_Version_Final_20240724 German.pdf (1.7 MB)
French:
COFEPRIS_Guia_Nitrosaminas_Version_Final_20240724 French.pdf (1.7 MB)
Portuguese:
COFEPRIS_Guia_Nitrosaminas_Version_Final_20240724 Portuguese.pdf (1.7 MB)
Chinese:
COFEPRIS_Guia_Nitrosaminas_Version_Final_20240724 Chinese.pdf (1.9 MB)
Thank you Naiffer! I can always count on the Nitrosamines Exchange Community!
Very, very quick skim read but one thing that appears to jump out (apologies if I am misreading this) - limits have been established and published for many molecules in Appendix 2. However, if there is a nitrosamine that isn’t on this list, then there is no mention of utilizing CPCA, and the limit defaults to 18 ng/day.
I also saw the same - this is a significant deviation from other health authorities; I would be very interested if anyone with connections to COFEPRIS could comment on the reasons for this - especially as most of the appendix 2 limits are CPCA-based.
There’s also no mention of the enhanced Ames test as far as I can see!
Some highlights from my side:
Step 1: Risk assessments 8 months and in spanish (we have everything in English here 
)
Step 2: Only at qualified labs from COFEPRIS. Internal Mexico market do not have capacity to absorb the testing of all. I infer foreign laboratories will need to apply. This is a lot of work.
Step 2 & 3: 3 years for confirmatory and implementation
Unknown nitrosamines will need to go to 18 ng/day. That effectivelly and let me say plainly will generate the same issue from EU in the past, shortages in some medicines.
I read Esomeprazole and Omeprazole there, the nitrosation compounds there are not nitrosamines per se… maybe a general nitrosamine makes sense there.
“The risk assessment must be prepared by qualified and experienced personnel required in the subject, which must be reviewed and authorized by the TRS and FIF in Mexico” We should all ask for authorization there
The only reference to something toxicological for nitrosamines is based on the ICH M7 (R2), that we all know until the next update, there are some missing gaps. Then what about Ames, TGRs, etc. Nonetheless, that studies I still see will come from big pharma, than local industry (too much resource intensive).
Nonetheless, wellcome move from COFEPRIS on behalf of patient safety, as with everything, not all is perfect but this was needed . Lets see if industry groups locally could further enhance the discussion. There are some politics topics, that hopefully would not make difficult the interaction on behalf of looking for improvements.
Tomorrow I will post a deep dive into the guide and appendix… as a community we have unique opportunity to gather insides, questions and/or ask clarifications. Please submit your questions or considerations.
Thank you Naiffer .Where we can have appendix II which contains acceptable intake
Thanks a lot Naiffer Romero for the updates. I think now this subject is spreading across the globe.
Well noted, thank you
Thank you Naiffer! for sharing COFEPRIS published Nitrosamines Guideline
See the top of the post for links
Further highlights:
Deadlines
@Naiffer_Host
Hi Mr. Naiffer,
Good morning…
Could you please share the English version of Annexure 1 & 2 of recently published Mexico Nitrosamine guideline.
Thanks
Nilesh
Unfortunately I do not have the appendix translation. They contains the API of concern and the AI limits respectively.
@Naiffer_Host
Ok Mr. Naiffer
Thanks for your reply…
Can we expect english translation copy, in future.
Dear Community, in the spirit of raising our nitrosamine-related voice!..
I have been given a unique opportunity to present at the upcoming “XI Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH).” Of course, Nitrosamines are an important topic, which is why we were invited to participate in the panel discussion!
