What Is CENAFyT in Mexico?

Post-market safety monitoring is a critical component of modern regulatory systems in the life sciences industry. Health authorities worldwide continue strengthening pharmacovigilance and surveillance mechanisms to ensure that medicines and medical devices remain safe throughout their lifecycle.

Within this context, Mexico has continued evolving its pharmacovigilance framework as part of broader regulatory reforms introduced in 2026. These reforms expanded the scope of the country’s national pharmacovigilance structure, transforming the National Pharmacovigilance Center (CNFV) into the National Center for Pharmacovigilance and Technovigilance (CENAFyT), coordinated by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) (Comisión Federal para la Protección contra Riesgos Sanitarios).

The Role of CENAFyT in Mexico’s Pharmacovigilance System

CENAFyT (Centro Nacional de Farmacovigilancia y Tecnovigilancia) serves as a national coordination structure responsible for strengthening the monitoring of the safety and performance of regulated health products in Mexico.

The center integrates pharmacovigilance and technovigilance activities within a unified framework that supports post-market surveillance for medicines and medical devices. Its role includes facilitating the detection, evaluation, and management of safety signals related to adverse drug reactions, device incidents, and other product safety concerns.

By consolidating these activities, CENAFyT contributes to improving the collection and analysis of safety information and reinforcing national surveillance systems for regulated health products.

Why It Matters for the Pharmaceutical Industry

For pharmaceutical and medical device companies operating in Mexico, robust pharmacovigilance systems are essential for maintaining regulatory compliance and ensuring patient safety.

Understanding how post-market surveillance activities are coordinated through structures such as CENAFyT may help organizations align internal pharmacovigilance processes, safety reporting mechanisms, and regulatory documentation with expectations from COFEPRIS.

Conclusion

As regulatory authorities continue strengthening lifecycle monitoring systems, structures such as CENAFyT reflect Mexico’s ongoing efforts to reinforce pharmacovigilance and technovigilance oversight.

For companies interested in entering or expanding within the Mexican pharmaceutical market, understanding how these surveillance structures operate can be an important element of navigating the country’s evolving regulatory landscape.

Navigating pharmacovigilance and post-market surveillance requirements in Mexico requires a clear understanding of how safety monitoring systems are coordinated within the regulatory framework. Freyr supports pharmaceutical and medical device companies with pharmacovigilance operations, regulatory intelligence, and compliance strategies aligned with COFEPRIS expectations—helping organizations maintain effective safety oversight while supporting regulatory readiness in the Mexican market.