Mexico Launches New Veterinary Pharmacovigilance System

The Ministry of Agriculture and Rural Development has launched a new Veterinary Pharmacovigilance System to enhance the safety, quality, and efficacy of animal medications. The system, developed by the National Service for Health, Safety, and Agri-Food Quality (SENASICA), aims to identify, assess, and mitigate risks associated with veterinary drugs sold in Mexico.

The system, managed by the General Directorate of Animal Health, collects data from veterinary product administrators to monitor and prevent adverse reactions in animals throughout the medication process. This initiative is designed to support the rational use of veterinary drugs and ensure the production of safe and healthy food.

Key stakeholders in the veterinary field, including pharmaceutical companies, distributors, veterinary hospitals, pharmacies, research units, and veterinarians, will be involved in the system. This collaborative approach is intended to streamline the reporting and management of adverse drug events.

As part of the system's rollout, SENASICA's Livestock Services and Certification Directorate conducted a two-day training session for 84 professionals from 47 pharmaceutical companies. The training, which included both in-person and virtual components, covered the history of pharmacovigilance in Mexico, the new regulatory framework, and essential concepts for evaluating drug safety.

Additionally, SENASICA introduced the Veterinary Pharmacovigilance Guide for Adverse Event Reporting (REAS) and Safety Report Preparation. This guide outlines procedures for documenting unexpected reactions not related to dosage or allergies, tracking events indicating potential efficacy failures, monitoring adverse reactions in humans, and addressing issues such as maximum residue limits and environmental concerns. The Veterinary Pharmacovigilance System will be implemented gradually and is expected to become a mandatory compliance tool for Mexico's veterinary pharmaceutical industry