Strengthening Veterinary Medicine Regulation

Introducing the Veterinary Medicines Regulatory Agency Self-Assessment Tool

Many countries lack the capacity to fully assess how effective their National Regulatory Authorities are in regulating veterinary medicines. This gap often leads to weak regulation, poor-quality or counterfeit medicines on the market and the misuse of antimicrobials [1]. The World Organisation for Animal Health (WOAH) supports countries in addressing these challenges by promoting enabling tools to help strengthen regulatory systems, improve veterinary medicine quality control and protect both animal and public health [2].

To bridge this gap, the United Kingdom Veterinary Medicine Directorate (UK-VMD) is developing and piloting the Veterinary Medicines Regulatory Self-Assessment Tool (VMRA-SAT). Designed to help countries assess how effectively they regulate veterinary medicinal products (VMPs), this pilot phase will show how effectively countries can evaluate their regulatory systems, identify weaknesses and strengthen their oversight of veterinary medicinal products [1].

What the Tool Assesses

The VMRA-SAT should guide national authorities through evidence-based questions covering:

• Legal authority to enforce regulations
• Definition and classification of veterinary medicine/medicinal product
• Institutional capacity and resources
• Risk management and compliance mechanisms
• Post-market monitoring of VMPs for safety, quality and efficacy
• Stakeholder and public engagement
  
  

After the assessment, countries receive a detailed report outlining strengths, weaknesses and recommendations for improvement [1].

Shaped by International Standards

To design the tool, the UK-VMD reviewed several assessment and benchmarking tools, including WOAH’s PVS Pathway, WHO’s Global Benchmarking Tool, the EU’s BEMA system and the World Bank’s EBA reports. It identified WHO’s Global Benchmarking Tool as the best fit. The VMRA-SAT adopts this tool’s structure – covering legal, institutional and operational areas – while tailoring its indicators to reflect how veterinary medicines are regulated in practice [1].

Collaboration and Pilot studies

The UK-VMD, in partnership with GALVmed and WOAH under the Better Regulation Project [3], has piloted the VMRA-SAT in several regions including Africa (Kenya, Tanzania, Uganda) and the Americas (Mexico, Chile) with more pilots planned in other regions of the world. The long-term goal is to fit the VMRA-SAT tool into a global veterinary regulatory strengthening framework that helps countries assess, compare and strengthen their veterinary medicines regulation.

Why It Matters

Effective regulation of veterinary medicines ensures that veterinary products used in animals are safe, effective and of high quality. This contributes directly to improved animal health and food safety while supporting global efforts to contain the development and spread of antimicrobial resistance (AMR) [4].

Call to Action

WOAH invites interested Members to explore or pilot the VMRA-SAT and share feedback to help refine and scale the tool globally. Kindly email the WOAH contact person below, who will liaise with the UK-VMD.

Together, we can strengthen veterinary medicine regulation and contribute to a safer, more sustainable future.

WOAH contact: Agatha Ugboma ([email protected])

---

References

1. Joseph N., Borriello S.P., Eckford S., Oyati O. (2025). – Development of a self-assessment/benchmarking tool for regulators of veterinary medicines. In Frontiers in Veterinary Science, Veterinary Humanities and Social Sciences, 12, 1648556. http://doi.org/10.3389/fvets.2025.1648556.  
2. World Organisation for Animal Health (WOAH) (2025). – Ensuring access to quality veterinary products. https://www.woah.org/en/what-we-offer/quality-veterinary-products/.
3. GALVmed (2024). – New project to improve access to quality veterinary products through better regulation in sub-Saharan Africa. https://www.galvmed.org/news/new-project-to-improve-access-to-quality-veterinary-products-through-better-regulation-in-sub-saharan-africa/.
4. Vidhamaly V., Bellingham K., Newton P.N., Caillet C. (2022). – The quality of veterinary medicines and their implications for One Health. BMJ Global Health, 7(8), e008564. https://gh.bmj.com/content/7/8/e008564.