Editorial – June 26

by Laure Geoffroy, Project Leader

When the European Commission presented its roadmap for phasing out animal testing, it did something more than outline a long-term objective. It put a spotlight on a reality many working in the field already recognise: the science is moving fast, but uptake in practice is uneven.

The question is no longer whether non-animal methods can support safety assessment. In many cases, they already do. The question is how these approaches become part of day-to-day regulatory work across sectors, while preserving the integrity of safety evaluations and delivering a level of protection equivalent to that expected from current approaches. That gap between what exists and what is routinely used is where NAMWISE can make a tangible difference.

Rather than starting from theory, the project works from the situations that regulators and industry actually face. Decisions still need to be made under uncertainty. Data still need to be weighed, combined and justified. By working through concrete use cases, NAMWISE helps show how non-animal data can be handled in practice, not just in principle. This is closely aligned with the direction set by the roadmap. The document calls for progress on several fronts at once: better use of existing methods, continued development of new ones, and stronger coordination between actors. None of these can move forward in isolation. NAMWISE contributes by connecting these pieces.

On the scientific side, it brings together different types of evidence from in vitro systems to computational models and considers how they can be interpreted together. On the regulatory side, it engages with the frameworks that are already in place, identifying where guidance is needed and where flexibility already exists but is underused.

Just as importantly, the project creates space for discussion across communities that do not always interact closely in their daily work. Regulators, method developers and end-users do not always look at the same problem in the same way. Structured exchanges through workshops, stakeholder panels and case-based discussions help to make those differences visible and, over time, easier to bridge.

The roadmap also makes clear that this transition will require more than technical readiness: it must actively force dialogue between those who develop NAMs, those who assess them, and those who will ultimately rely on them in regulatory decisions. This is reflected in the creation of expert platforms at agency level, including ECHA’s collaborative platform  (CP-AAT) to bring together regulators, Member States experts, and stakeholders around the regulatory use of non-animal approaches, validation, standardisation and concrete scientific challenges. A similar need exists in the pharmaceutical sector, where dialogue with EMA and academic and industry NAM developers is essential to ensure that innovative methods are discussed early, understood in their scientific context and progressively connected to regulatory expectations. NAMWISE is directly positioned to contribute to this movement: its case studies can provide practical material for expert discussion, while the External Stakeholder Panel offers a structured interface through which regulators, agencies, researchers, industry and other end-users can challenge, refine and disseminate the project’s findings, turning its work into a concrete input for the wider implementation of the roadmap.

Training is another piece of the puzzle. Moving towards non-animal approaches requires new skills, but also familiarity. For many assessors, the challenge is not resistance but lack of exposure. Providing practical examples, rather than abstract guidance, helps build confidence more effectively than general statements about potential.

In this sense, NAMWISE is not separate from the roadmap. It works within the same trajectory, focusing on the points where progress tends to slow down: interpretation of data, consistency across frameworks, and confidence in decision-making. The transition described in the roadmap involves changes in methods, in processes, and in how evidence is judged, while maintaining the integrity of safety evaluations and an equivalent level of protection for human health and the environment. Projects like NAMWISE do not replace that broader effort, but they can help it move forward in a structured way.

By testing approaches, documenting what works and where difficulties remain, and feeding that experience back into the wider discussion, NAMWISE can remain closely involved as the roadmap evolve from a statement of intent into established practice.