In November, 2024 The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) adopted a revised guideline on the ‘Evaluation of the Benefit-Risk Balance of Veterinary Medicinal Products’ to further enhance its assessment procedure for veterinary products within the EU.The revision, set to come into effect in May 2025, will align with the existing regulatory and scientific framework established by Regulation (EU) 2019/6 which covers several key aspects of veterinary medicines including authorization and use of veterinary medicinal products and pharmacovigilance among others.
Since the original guideline’s adoption in 2009, there have been several regulatory changes, breakthroughs and new concerns over issues like antimicrobial resistance which have necessitated an update by the CVMP. The update, a thirteen-page document offers a new and more structured approach to benefit-risk balance evaluation of veterinary medicinal products for a more consistent and transparent decision-making by authorities by offering a systematic approach to both pre- and post-authorization assessments.
This means, regulatory assessments for veterinary medicinal products are now based on a structured and risk-driven approach that factors in not just the product’s benefits but also the potential hazards to animals, humans, and also the environment. While regulatory requirements for the sector have always been strict, marketing authorization holder, veterinarians and other stakeholders should expect even stricter requirements to demonstrate medicines safety and efficacy in addition to ongoing monitoring and reporting obligations as the globe shifts towards stricter pharmacovigilance.