The Mexican Pharmaceutical Council (CFM) highlighted the opportunities arising from greater cooperation between the FDA, Cofepris, and Health Canada.
The FDA, Cofepris, and Health Canada share relevant regulatory functions: authorizing drugs, monitoring their safety, evaluating efficacy and quality, supervising good manufacturing practices, issuing health alerts, withdrawing risky products, and protecting public health through market control and supervision.
FDA, Cofepris, and Health Canada
These three agencies are dedicated to regulating, authorizing, and monitoring drugs in the United States, Mexico, and Canada, respectively.
“We see enormous potential in deeper cooperation between the FDA, COFEPRI, and Health Canada,” said Alejandro Sanders, executive director of the CFM, at a USTR hearing held on December 3, 2025, in Washington on the six-year review of the USMCA.
In his view, mutual trust in inspections, joint pathways, and the FDA’s permanent presence in Mexico are practical measures that will strengthen oversight and speed up approvals.
At the same time, he added, government procurement can be a decisive catalyst.
“A North American approach to procurement of essential medicines, APIs, and KSMs would provide the industry with the long-term certainty needed for significant investments,” Sanders said.
Supply chains
For the CFM, strengthening regional security functions would have positive effects. First, on economic security. Then, on public health in North America. In addition, it would position the region as a key player in cooperation strategies between regional blocs.
In turn, the parties to the USMCA could benefit from more resilient and integrated supply chains. They would also benefit from greater availability of medicines in all three countries. At the same time, innovation and intellectual development processes within the region would be strengthened.
Finally, the CFM maintains that the pharmaceutical industry can replicate the integration achieved in other strategic sectors. To this end, it proposes common standards, specific incentives, and joint innovation and investment strategies. North America already has talent, science, and a solid manufacturing base.
“A region can only achieve sustained productivity, prosperity, and justice when its neighboring populations enjoy health, safety, and prosperity. We believe that now is the time to move from dependence to resilience, from fragmentation to integration, from vulnerability to leadership,” Sanders said.