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As Mexico’s pharmaceutical industry continues to grow, Regulatory updates are being introduced to improve drug quality, speed up approval processes, and align with international standards. Here are three major changes shaping the Regulatory landscape in 2025:
1. Updated GMP Guidelines: Changes to NOM-059-SSA1-2015
Mexico’s Official Standard NOM-059-SSA1-2015, which outlines Good Manufacturing Practices (GMP) for pharmaceuticals, is undergoing important changes.
These updates are designed to improve the approval timeline for biotechnological drugs by aligning Mexico’s regulations more closely with global GMP standards. The goal is to ensure medicines are safe, effective, and of high quality.
The revised standard will officially come into effect on December 1, 2025.
2. Regulatory Reliance: Recognizing Global Approvals
To streamline clinical research and drug evaluations, the Mexican Ministry of Health is adopting Regulatory Reliance Practices.
This means COFEPRIS (Mexico’s health regulatory agency) can now consider the evaluations done by respected international agencies such as:
- European Medicines Agency (EMA)
- U.S. Food and Drug Administration (FDA)
- UK’s MHRA
- Health Canada
By recognizing approvals from trusted authorities like the European Medicines Agency, Mexico aims to accelerate access to innovative therapies while upholding safety and quality.
3. Stronger Pharmacovigilance: Monitoring Drug Safety
To ensure the ongoing safety of medicines, COFEPRIS is enhancing its pharmacovigilance efforts.
This includes:
- Conducting awareness campaigns
- Improving how adverse drug reactions are tracked and managed
- Ensuring timely responses to safety concerns
These efforts reflect Mexico’s commitment to public health by detecting risks early and protecting patients more effectively.
Conclusion
These regulatory changes reflect Mexico’s dedication to creating a robust and transparent pharmaceutical environment—one that welcomes innovation while safeguarding public health.
At Freyr, we support pharmaceutical companies in staying compliant with evolving regulatory frameworks across LATAM and beyond.
From product registration to pharmacovigilance and GMP consultation, our experts are here to help you navigate every step with confidence.
Contact us today to ensure your products meet Mexico’s 2025 regulatory standards.
