Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

INVIMA grants the sanitary registration (registro sanitario) that a medicine needs to be sold in Colombia. Under Decreto 677 de 1995 a new medicine needs a pharmacological evaluation, a judgement on its usefulness, suitability and safety, which is reserved to a specialist committee (the Comisión Revisora, now its Sala Especializada de Medicamentos). The decree gives that committee 180 working days, with the clock stopped while the applicant answers questions, or 30 working days when the medicine is registered in at least two reference countries and has not been rejected in any; the reference countries are the United States, Canada, Germany, Switzerland, France, England, Denmark, the Netherlands, Sweden, Japan and Norway. For biological medicines, Decreto 1782 de 2014 allows three routes, the full dossier, comparability and abbreviated comparability, holds them to the same standard, and gives INVIMA three months after a favourable pharmacological evaluation to decide on registration, which then lasts five years.

Since Decreto 433 de 2018, an applicant for a new medicine also files a comparative dossier and its intended price, which INVIMA passes to the Instituto de Evaluación Tecnológica en Salud for a classification of therapeutic value in parallel; the result goes to the national price commission, and after 180 days without a final opinion the requirement is treated as met.