EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.

ITF is a dedicated forum for early dialogue between regulators and developers of medicines to discuss innovative aspects such as emerging therapies, methods and technologies. Set up to ensure coordination across the Agency, the ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It will provide an opportunity to discuss 3R-compliant methods and facilitate their integration into the development and evaluation of medicinal products.

The ITF’s service is free of charge and any NAMs adhering to the 3Rs principles that can be used to fulfil testing requirements are eligible for consideration.

Alternative approaches to animal models, such as improved tests based on human and animal cells, organoids, organ-on-chips and in silico modelling, provide opportunities to develop better and more predictive scientific tools to protect human and animal health as well as the environment.

Opening the ITF platform to discussions of 3Rs-compliant methodologies is expected to encourage prioritising and speeding up the integration of alternative methods into the regulatory framework. This action supports the reduction of animal use and is in line with EMA's Regulatory Science Strategy to 2025 aiming to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine.

EMA press release, 29/09/2021