The animal health sector’s perspective

AnimalhealthEurope developed a detailed sector-specific Roadmap identifying the main challenges, both technical and regulatory, faced by the animal health industry in the implementation of new approach methodologies (NAMs). The animal health sector strongly supports the accelerated development, validation and uptake of technologies and methods to reduce reliance on animal-based tests in the research, manufacturing and authorisation of veterinary medicines.

International harmonisation in the regulatory acceptance of NAMs is an essential element for successful outcomes globally.

Our Commitment to the 3Rs approach

In the EU, animal health companies are required by law to demonstrate that all veterinary medicines are effective and safe for the animal patient, the user, the consumer and the environment. This evidence is generated using a range of testing techniques, including chemical, physical, in silico, in vitro and in vivo.

Our members are committed to the phase-out of animal-based tests, wherever and whenever possible, under the 3Rs approach — Replacement, Reduction and Refinement — and the science-based phase-in of new approach methodologies (NAMs).

Whilst there is no single replacement for animal testing, and various tests are required by legislation, we will work together with all stakeholders involved to drive forward the phase-out of animal testing where scientifically feasible. The final stages of safety and efficacy testing for veterinary medicines will, however, always need to be conducted in the target species.