Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Profile narrative

INVIMA, also known as the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, is Colombia’s national authority responsible for the regulation, control, and surveillance of medicines, foods, medical devices, cosmetics, and related health products. Its mandate includes evaluating the safety, efficacy, and quality of these products before they can be marketed, issuing sanitary registries, and monitoring compliance through inspections and post‑market surveillance. The institute serves domestic manufacturers, importers, exporters, and healthcare professionals by providing the permits and certifications required for legal distribution and use of regulated goods. It also oversees port inspections to verify that imported products meet national sanitary standards and collaborates with other public health entities on quarterly safety reporting and alert systems.

As a public institution, INVIMA operates under the Ministry of Health and Social Protection of the Colombian government, giving it a governmental mandate that extends across the entire national territory. Its regulatory activities are not limited to a specific sector but cover the full spectrum of health‑related commodities, positioning it as the central point of reference for both industry stakeholders and consumers seeking assurance about product safety. The institute’s work is evident in the critical services it provides, such as the issuance of export certifications, the facilitation of port clearance procedures, and the maintenance of a national database of adverse event notifications.

The institute’s distinguishing attributes stem from its specialized focus on vigilance—combining pre‑market evaluation with ongoing post‑market monitoring to ensure continuous protection of public health. This dual approach enables INVIMA to detect emerging risks, enforce corrective actions, and maintain confidence in the national supply chain of medicines and foods. Notably, INVIMA’s technological platform supports the delivery of these services online, a fact highlighted by the cyber incidents it experienced in February and October 2022, when attacks on its information systems disrupted the web portal, blocked access to permit processing, and interrupted port inspections and safety reporting, underscoring the reliance of its operations on secure digital infrastructure.

Incidents

2 incidents linked to this organisation.