COFEPRIS
Mexico's Federal Commission for Protection against Health Risks, the regulator for clinical trials and marketing authorizations.
What it means
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico's health regulator. It authorizes clinical trials and reviews marketing authorization dossiers. All submissions must be in Mexican Spanish, including protocols, informed consent forms, and regulatory correspondence.
Why it matters for LATAM submissions
COFEPRIS uses a formal requerimiento process. Translation errors that trigger a requerimiento reset the review clock, so country-specific terminology and complete certification matter.
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