Overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Scientific guideline

This reflection paper provides an overview of the main tests that involve the use of animals that are required for the regulatory testing of veterinary medicines. It also includes opportunities for further improvement in the application of 3Rs. A parallel document on human medicines is also available.

Keywords: 3Rs, regulatory testing, regulatory acceptance, testing approaches, veterinary medicines

Current version - under consultation

Draft reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Revision 1

Draft: consultation closed Consultation dates: 13/02/2025 to 30/06/2025 Reference Number: EMA/CHMP/CVMP/3Rs/164002/2016 Rev. 1

Document history

Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs

Adopted Reference Number: EMA/CHMP/CVMP/3Rs/164002/2016

Overview of comments received on 'Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs' (EMA/CHMP/CVMP/3R...

Reference Number: EMA/CHMP/CVMP/3Rs/731924/2016

Draft reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs

Draft: consultation closed Consultation dates: 29/04/2016 to 31/10/2016 Reference Number: EMA/CHMP/CVMP/JEG-3Rs/164002/2016 Summary:

In October 2014 the CHMP and CVMP agreed a draft guideline for consultation on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (EMA/CHMP/CVMP/JEG- 3Rs/450091/2012).