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Mexico’s National Regulatory Authority (NRA) for medicines and vaccines, led by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has been officially pre-selected by the Pan American Health Organization (PAHO) as a candidate to obtain the status of World-Listed Authority (WLA) by the World Health Organization (WHO).

This recognition, formerly known as “Level IV” or “Regional Reference Authority,” represents an international validation of the agency’s technical competence, independence, transparency, and regulatory compliance.
Being designated as a WLA not only strengthens the institutional position of COFEPRIS but could also have a transformative impact on Mexico’s regulatory ecosystem and its leadership role within Latin America.

Why WLA Status Matters

According to WHO, a WHO-Listed Authority (WLA) is one that has demonstrated the capacity to perform essential regulatory functions in alignment with international standards. This designation allows other health authorities around the world to adopt its regulatory decisions through mechanisms of trust and technical cooperation.

For the industry, this may translate into key advantages:

  • Greater international recognition of registrations issued by COFEPRIS
  • Reduction of duplicative procedures for exports
  • Potential acceleration of approvals in markets that recognize WLAs
  • Increased attractiveness for pharmaceutical and biotech investments in Mexico

What Stage Is COFEPRIS In?

According to PAHO’s official site, COFEPRIS has already been pre-selected and is currently undergoing technical evaluation toward formal designation.
To date, only three agencies in the Americas hold WLA status: ANVISA (Brazil), Health Canada, and the U.S. FDA.

While no official timeline has been published for a final decision, COFEPRIS’s selection as a candidate reflects the institutional progress made in recent years, particularly in areas like digitalization (via DIGIPRIS), transparency, and technical autonomy.

What Could This Mean for Regulated Companies?

From a strategic standpoint, the potential recognition of COFEPRIS as a WLA reinforces its role as a key player in regional regulatory convergence. For regulated companies, this may imply:

  • The need to align internal processes with higher regulatory standards
  • Enhanced traceability, consistency, and technical justification in regulatory submissions
  • Opportunities to design market-entry strategies based on COFEPRIS-issued decisions
  • Strengthening of good regulatory practices, documentation quality, and use of CTD/eCTD structures

Inclusion on the WLA list would also reinforce the principles of regulatory reliance, enabling deeper collaboration between agencies and potential cross-recognition of regulatory decisions across the region.

A Pragmatic Approach to Regulatory Transition and Planning

The possible WLA designation of COFEPRIS implies not only regulatory shifts, but also the need to rethink strategies aligned with convergence, global standards, and inter-agency cooperation.

In this context, having specialized support becomes essential to:

  • Interpret evolving regulatory frameworks through a technical and regional lens
  • Identify potential impacts on registration management and product lifecycle
  • Evaluate opportunities arising from reliance or cross-recognition models
  • Strengthen internal capabilities to meet future regulatory demands without improvisation

At Freyr, we work closely with regulatory teams to support informed, sustainable, and regionally adapted decision-making in an evolving Latin American regulatory landscape.

Want to know more or need support? Contact us.