Mexico Pharmacovigilance Resources

COFEPRIS pharmacovigilance regulation, NOM-220-SSA1-2016, national reporting routes and current guidance for Mexico.

Resource family Country & Regional Pv Requirements
Resource type Country Pharmacovigilance Reference Hub
Maintained by Comisión Federal para la Protección contra Riesgos Sanitarios
Jurisdiction Mexico
Status Official Mexican pharmacovigilance regulation and guidance
Access Public
Official link verified 2026-09-04
Official source Visit official resource ↗

Pharmacovigilance in Mexico is coordinated by COFEPRIS through the Centro Nacional de Farmacovigilancia and the national pharmacovigilance system.

Core official resources

Practical use

NOM-220-SSA1-2016 remains the core Mexican pharmacovigilance standard, together with its 2020 modification. Operational procedures should be checked against the latest COFEPRIS guidance and reporting instructions because the agency periodically updates implementation material.