Chile

Chile is regulated by the Instituto de Salud Pública de Chile (ISP) through its Departamento Agencia Nacional de Medicamentos (ANAMED), under the Ministerio de Salud (MINSAL) and the Subsecretaría de Salud Pública. ISP was created by Law 18.164 (1982); the medicines framework is set by the Sanitary Code (DFL 725/1967) and Decreto Supremo 3 of 2010 (Reglamento del Sistema Nacional de Control de los Productos Farmacéuticos de Uso Humano), as amended by DS 65/2019 (therapeutic equivalence) and DS 30/2019 (biological products). ANAMED was designated by PAHO as a Regional Reference Authority of the Americas (Nivel IV) in 2011. Chile is a PIC/S full member (since 2017) and operates a tiered framework with reliance on assessments from recognised reference authorities (FDA, EMA, MHRA, Swissmedic, Health Canada, PMDA, TGA) under the abbreviated registration route. Bioequivalence is mandatory for an expanding list of products under DS 65/2019. Chile is a high-income market with universal coverage delivered by FONASA (public) and ISAPREs (private). Catastrophic and high-cost coverage is provided by GES/AUGE (Garantías Explícitas en Salud, Law 19.966) and the Ley Ricarte Soto (Law 20.850 of 2015) for high-cost diagnostics and treatments including rare diseases. CENABAST handles centralised public-sector procurement. There is no mandatory price-setting for medicines, but ETESA (Evaluación de Tecnologías Sanitarias) within MINSAL conducts national HTA for Ricarte Soto and AUGE inclusion.