An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the Mexican regulatory system for the assessments of innovative new products have had a negative impact on approvals of innovative medicines.

This CIRS Briefing addresses the impact of suspending the activities of the New Molecules Committee (NMC) on the Mexican therapeutic landscape. Our findings indicate the regulatory approval system that had been in place prior to the NMC ceasing its activities provided an opportunity for innovative products to obtain regulatory approval, despite recognised long timelines and process inefficiencies. The current situation has severely curtailed the availability of innovative products; this landscape could be improved by the reinstitution of the NMC, the more effective use of accelerated pathways and by prioritising the assessment of critically important new medicines.

If you have any questions or comments on this Briefing, please don’t hesitate to get in touch with Dr Lawrence Liberti: