Mexico

Pharmacovigilance in Mexico is coordinated by COFEPRIS through the Centro Nacional de Farmacovigilancia (CNFV). The governing Spanish-language standard is NOM-220-SSA1-2016, Instalación y operación de la farmacovigilancia, as modified, and it is mandatory for holders of sanitary registrations and their legal representatives. The standard requires relevant pharmacovigilance units to designate a trained responsable de Farmacovigilancia, maintain documented procedures and quality controls, submit individual safety reports to the CNFV, and participate in risk-management activities. For medicines, the NOM’s reporting table sets a maximum of 7 calendar days for serious suspected adverse reactions/adverse events and 90 calendar days for non-serious cases in the spontaneous/stimulated pathway; clusters of two or more similar serious cases involving the same medicine and batch must be reported immediately and no later than 48 hours, lack of efficacy within 15 calendar days, and scientific-literature notifications within 30 calendar days. The NOM also establishes Periodic Safety Reports (RPS) and Planes de Manejo de Riesgos (PMR) and provides for routine or targeted pharmacovigilance verification by COFEPRIS. Mexico does not use an EU PSMF as a universal statutory concept, so EU PSMF/QPPV rules should not be substituted for the Mexican framework. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.