As numerous factors have recently contributed to changes in the regulatory environment, we have been monitoring and analysing structural regulatory issues affecting overall access to medicines in the Latin Americas. As part of this research, CIRS developed R&D Briefing 76 to understand the impact of recent regulatory developments on the Mexican therapeutic landscape.
The objectives of this R&D Briefing and its recent Addendum were to gain a better understanding of:
- the impact of changes in the Mexican regulatory environment on the availability of new medicines for Mexican patients
- the way ‘new medicines’ are defined
- the impact of suspending the activities of the New Molecules Committee (NMC)
- the extent to which new drugs approved by the US FDA have been approved by other important jurisdictions specifically Argentina, Brazil, Canada, Chile, EMA and Mexico.
We recently presented our findings in a regional webinar attended by over 120 people; the slides from this webinar can be downloaded here.