Colombia
Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
Colombia is regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), a deconcentrated body of the Ministerio de Salud y Protección Social created by Law 100 of 1993 and Decree 1290 of 1994. INVIMA regulates medicines, biologics, biosimilars, medical devices, IVDs, vaccines, blood products, food and cosmetics. The core medicines framework is Decree 677 of 1995 (the Colombian Medicines Statute) plus Decree 1782 of 2014 (biological medicines), Decree 843 of 2016 (simplified renewal/variation), Decree 481 of 2004 (Vital No Disponibles), Decree 335 of 2022 (GMP/GLP/GMP-clinical certification), Resolución 2378 of 2008 (GCP) and Resolución 2024015321 of 2024 (pharmacovigilance). Colombia operates a tiered framework with reliance for products approved by recognised authorities — INVIMA's Sala Especializada de Medicamentos (Comisión Revisora) accepts foreign assessment reports from FDA, EMA, Health Canada, Swissmedic, MHRA, PMDA, TGA and reference bodies of higher sanitary surveillance, although Colombia does not yet operate a formal verification-style pathway. INVIMA was designated by PAHO as a Regional Reference Authority of the Americas (Nivel IV) in 2011 and is a PIC/S full member (since 2024). Colombia is the fourth-largest pharmaceutical market in Latin America. Coverage is delivered through the contributory and subsidised regimes of the Sistema General de Seguridad Social en Salud (SGSSS); the Plan de Beneficios en Salud (PBS, formerly POS) is funded through the per-capita UPC. Non-PBS prescriptions are channelled through the MIPRES system. Pricing is regulated by the Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM) under direct, indirect and value-based pricing methodologies (Circular 03/2013, Decree 433/2018 and CNPMDM Circular 18/2024). The Instituto de Evaluación Tecnológica en Salud (IETS) provides national HTA.
About the authority
INVIMA is structured around the Dirección de Medicamentos y Productos Biológicos (DMPB — drug and biologic registration, post-market surveillance, pharmacovigilance), Dirección de Dispositivos Médicos y Otras Tecnologías, Dirección de Operaciones Sanitarias (inspections, GMP) and Dirección de Alimentos y Bebidas. Marketing-authorisation decisions are taken by INVIMA following technical recommendation of the Sala Especializada de Medicamentos y Productos Biológicos of the Comisión Revisora — a multidisciplinary scientific committee that meets monthly. Submissions are filed through INVIMA's Oficina Virtual electronic portal.
International affiliations
Reliance & recognition
INVIMA accepts assessment reports and approved labelling from recognised reference authorities as supporting evidence within the standard registration route, and operates a partial-reliance abbreviated comparability pathway under Decree 1782/2014 for biologics. INVIMA's PAHO Regional Reference Authority (Nivel IV) status, PIC/S full membership and growing use of foreign GMP certificates underpin practical reliance for both medicines and devices, although there is no formal verification-style recognition pathway.
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