A Regulatory Database for the Global Veterinary Diagnostics Market: Mapping 120+ Countries for Industry Leaders

Context

An international federation representing veterinary diagnostics manufacturers had identified the need to develop a reference tool to support its regulatory convergence activities, in a sector where the frameworks applicable to diagnostic kits vary considerably from country to country.

The challenge

Unlike human in vitro diagnostic devices which benefit from an international regulatory convergence strategy, the requirements applicable to veterinary diagnostics remain highly heterogeneous across countries. Identifying these requirements in a reliable and reproducible way represented a major methodological challenge.

The One Health Compliance solution

• Definition of key information categories, research and analysis of regulatory requirements for each target country according to the federation’s priorities.
• Iterative development of the tool in collaboration with the regulatory working group, to ensure its operability and field relevance.

The result

• A regulatory requirements mapping tool, launched with 19 countries and now covering over 120 countries used by global industry leaders in their compliance activities and exchanges with the WOAH (World Organisation for Animal Health).

✓ 120+ countries covered ✓ Reference tool used by global industry leaders ✓ Presented in exchanges with the WOAH 

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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