NAMs and the European Biotech Act: A Strategic Opportunity for In Silico Medicine

A recent event at the European Parliament brought renewed attention to the growing role of NAMs highlighting the forthcoming European Biotech Act as a major opportunity to accelerate the transition toward non-animal science while strengthening Europe’s global competitiveness.

The discussion gathered representatives from EU institutions, scientific organisations and civil society, all emphasizing the urgent need to modernise biomedical and environmental research through more human-relevant, ethical and technologically advanced methods.

At the centre of the debate were NAMs — a broad category of innovative tools that includes organoids, organ-on-chip systems, advanced computational modelling and AI-driven approaches. These technologies are increasingly recognised as scientifically robust alternatives to traditional animal testing, with the potential to improve translational relevance, accelerate innovation and reduce research costs.

For the in silico community, the event confirmed a significant policy shift underway across Europe. Computational toxicology, AI-assisted drug discovery, mechanistic modelling and digital twins are no longer viewed as emerging niche technologies, but as essential pillars of next-generation biomedical research and regulatory science.

Speakers stressed that one of the key challenges remains the absence of a clear and harmonised definition of NAMs across EU legislation. Without consistent terminology and regulatory alignment, the adoption and validation of innovative methods risks remaining fragmented between sectors and Member States. They also highlighted the importance of sustained investment, stronger research infrastructure, integration of NAMs into education and training, and closer cooperation between science, industry and regulators.

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