It would be interesting to understand the reasoning (and procedural impact) of COFEPRIS in adopting principles like CPCA, EAT, in vivo mutagenicity testing indirectly via Appendix 2 but not really in the key guidance. Can they evaluate AIs with no international publication precedent (linked to the NDSRI structure and/or value proposed) or do they only endorse already published AIs? (And if this has a link with defaulting to 18 ng/day.)
Would also like to hear the perspective on international recognition from other panelists like ISP Chile having no nitrosamine guidance/regulation beyond ranitidine and sartans and more broadly how these non-NITWG members look at NITWG.
Thank you for sharing a summary of the panel output later this month.
Hi Naiffer, thanks for bringing up this with the Community - unique opportunity indeed
For Mexico: how is the Authority planning to implement, considering key factors as the listed by @Diego_HM and @ccdw some days ago in this “conversation line”, from which I see as critical the requirement for local personnel/lab to perform activities, unknown nitrosamines “falling by default” into 18 ng/day and the acceptability of EAT and in-vivo mutagenicity data
For other NRAs would be good to “explore” if there is any potential upcoming update/guidance already planned or “in the table as idea” to be issued by their side
Will be of very much interest any output you could share after the Conference.
