Mexico

Mexico is regulated by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), a deconcentrated body of the Secretaría de Salud created by the 2001 reform to Article 17 bis of the Ley General de Salud (LGS). COFEPRIS regulates medicines, biologics, biocomparables (biosimilars), medical devices, IVDs, vaccines, blood products, cosmetics, food, tobacco and pesticides under the LGS and the Reglamento de Insumos para la Salud (RIS). Since 2020, and reinforced by the July 2025 abbreviated pathway agreement, Mexico has accelerated reliance on Autoridades Reguladoras de Referencia (ARR/AAR-equivalence) including FDA, EMA, Health Canada, Swissmedic, TGA, PMDA, MHRA and WHO Prequalification. The Equivalence Agreement (Acuerdo de Equivalencia, originally 2012, expanded 2020 and 2024) lets COFEPRIS rely on a foreign approval and shorten review for both medicines and devices. Mexico is a PIC/S applicant, ICH observer, and a founding member of PANDRH. Mexico is the second-largest pharmaceutical market in Latin America (after Brazil), with public procurement (IMSS, ISSSTE, INSABI/IMSS-Bienestar) dominating volume and the Cuadro Básico y Catálogo de Insumos del Sector Salud (managed by the Consejo de Salubridad General, CSG) governing public-sector access. Patent-protected products go through the CCNPMIS price-negotiation commission for public reimbursement.