Overview
Mexico has taken a decisive step in modernizing its healthcare system with the creation of the National Center for Pharmacovigilance and Technovigilance (CENAFyT). Integrated into the General Health Law, this new body expands supervisory powers over both medicines and medical equipment, ensuring greater protection for all citizens.
Introduction
In the dynamic landscape of public health, constant surveillance is the first line of defense against sanitary risks. In a historic announcement made in Mexico City, COFEPRIS (Federal Commission for Protection against Sanitary Risks) officially transitioned the former National Pharmacovigilance Center (CNFV) into the new CENAFyT.
This change is more than just a name update; it reflects the reforms to the General Health Law published in January 2026. It positions Mexico as a leader in technical-scientific regulation within Latin America by consolidating safety monitoring for both pharmaceutical and technological medical products.
What Changes with CENAFyT
The primary evolution of this structure is administrative and strategic unification. While the previous model focused predominantly on pharmaceuticals, CENAFyT establishes Technovigilance as a pillar of equal importance.
Centralized Coordination: The center now coordinates, with greater authority, the reporting of adverse reactions and the management of incidents related to medical technologies—ranging from simple syringes to complex diagnostic equipment.
Regulatory Updates: CENAFyT holds direct responsibility for updating and controlling fundamental technical standards:
- NOM-220-SSA1-2016: Guidelines for Pharmacovigilance.
- NOM-240-SSA1-2012: Guidelines for Technovigilance.
Data Integration: All members of the National Pharmacovigilance System must now align their databases, communications, and official reports with this comprehensive new structure.
Impact on Public Health
The consolidation of CENAFyT allows for early risk identification. By constantly monitoring the life cycle of products—from the consumption of medicines to the use of equipment in hospitals—the healthcare system becomes preventative rather than reactive. This ensures that the quality and efficacy of all treatments available in the national market are maintained under the highest international standards.
Conclusion
The creation of CENAFyT represents an unprecedented institutional advancement for Mexico. By raising the bar for surveillance over medicines and medical devices, COFEPRIS is not only modernizing public administration but fulfilling its essential commitment: protecting the health of the population. This milestone strengthens trust in the sanitary system and ensures that medical innovation always goes hand-in-hand with patient safety.
.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about.
- General Health Law. Reforms published in the Official Gazette of the Federation (DOF) on January 15, 2026.
- Press Release: Creation of the National Center for Pharmacovigilance and Technovigilance (CENAFyT). Mexico City, March 9, 2026.
- SECRETARY OF HEALTH. Official Mexican Standard NOM-220-SSA1-2016, Installation and operation of pharmacovigilance.
- SECRETARY OF HEALTH. Official Mexican Standard NOM-240-SSA1-2012, Installation and operation of technovigilance.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.
