Abstract

Latin America has progressed in the post-marketing care and assessment of veterinary products by structured surveillance (pharmacovigilance), risk−benefit assessment and regulatory monitoring throughout the product lifecycle. This regulatory evolution is driven by the growing adoption of the ‘One Health’ concept, given the indirect links between veterinary products and human health, food safety and the environment.

In Brazil, regulations governing veterinary pharmacovigilance and recent restrictions on antimicrobial use demonstrate that national systems are incorporating these globally significant programmes. While countries like Chile and Colombia show notable regulatory variation, they already have well-structured veterinary pharmacovigilance programmes. Regional initiatives such as the American Committee on Veterinary Medicines (CAMEVET) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) foster scientific convergence and provide widely used operational guidelines; however, they do not replace national regulations for registering or authorising veterinary products.

The next step for Latin America envisions the consistent implementation of regulatory and pharmacovigilance systems, characterised by solid regulatory capacity among governmental agencies and drug companies, alongside transparent, traceable procedures.

This article examines how the regulation of veterinary medicines in Latin America is shifting from pre-market authorisation towards oversight of the entire product lifecycle, using recent Brazilian reforms as a case study and placing them within a region marked by national heterogeneity and ongoing harmonisation efforts.