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Mexico's regulatory landscape has taken a significant step toward international harmonization. In March 2024, the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) published a new agreement in the country’s Official Gazette (DOF) that allows the recognition of Good Manufacturing Practice (GMP) certificates issued by trusted regulatory authorities across the Americas and beyond.

This regulatory milestone opens the door for medicines manufactured outside of Mexico to be evaluated and approved based on COFEPRIS' confidence in the standards applied by globally aligned health authorities.

Recognition Based on Regulatory Trust

The new framework enables COFEPRIS to accept GMP certificates issued by foreign authorities during the drug registration process, provided those authorities are considered reliable and operate under internationally accepted standards.

This recognition is based on the principle that the regulatory requirements of the issuing authority are sufficient to satisfy COFEPRIS' own quality, safety, and efficacy expectations, thereby avoiding duplication and streamlining procedures without compromising technical rigor.

Recognized Reference Authorities

The agreement categorizes recognized authorities into two major groups:

1. Authorities from the Americas:

  • ANMAT (Argentina)
  • ANVISA (Brazil)
  • INVIMA (Colombia)
  • ISP (Chile)
  • CECMED (Cuba)
  • Health Canada (Canada)
  • FDA (United States)

2. Global Authorities:

  • Members of PIC/S (Pharmaceutical Inspection Co-operation Scheme), including:
    • TGA (Australia)
    • MHLW (Japan)
  • Authorities listed as WHO Listed Authorities (WLA) with maturity level 4, such as:
    • MFDS (Republic of Korea)
    • HSA (Singapore)
    • SFDA (Saudi Arabia)

This recognition expands opportunities for high-standard pharmaceutical products to access the Mexican market more efficiently.

Documentation Requirements for Acceptance

GMP certificates issued abroad must either:

  • Be apostilled, or
  • Have a verifiable digital signature and traceable electronic record.

This ensures COFEPRIS can validate the authenticity of submitted documentation without requiring additional notarial or physical procedures.

Impact on the Pharmaceutical Industry

This recognition mechanism significantly reduces registration timelines and regulatory costs. It facilitates faster access to approved treatments for patients while easing operational barriers for foreign manufacturers.

At a strategic level, it reinforces Mexico's role as a collaborative regulatory authority aligned with international best practices.

How Can Freyr Strengthen Your Regulatory Strategy?

At Freyr Solutions, we help pharmaceutical companies optimize their drug registration processes in Mexico by leveraging recognized GMP certificates, ensuring COFEPRIS compliance, and accelerating approval timelines. Our services include:

  • Technical review and validation of certificates issued by recognized authorities
  • Regulatory consulting for submission strategies involving mutual recognition
  • Legal representation and compliance monitoring in Mexico

Ready to optimize your market entry strategy in Mexico?
Connect with our experts and learn how to leverage this new framework to accelerate your product approvals.