Colombia’s pharmacovigilance system for medications has historically been guided by Decree 2200 of 2005.

The latest regulation concerning pharmacovigilance in Colombia is Resolution 2024015321 of 2024, which outlines the framework for the National Pharmacovigilance System (SNFV).

This resolution sets forth the requirements for pharmacovigilance officers, introduces a risk-based classification for holders of marketing authorization, and enhances the processes for the reporting and analysis of adverse events on a national scale.