The European Medicines Agency (EMA) has debuted a new voluntary pilot scheme designed to help preclinical toxicologists secure feedback on data generated from new approach methodologies (NAMs), as global regulators champion the move away from animal testing in preclinical research.
Under the new voluntary data submission (VDS) initiative, the EMA hopes to create a structured, non-binding framework that allows key players such as industry members, method developers, academics and contract research organisations (CROs) to share and discuss NAM data with experts without having to put forward an approval application.
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Upon submission, the EMA notes that pilot scheme participants will receive individual feedback from a group of non-clinical experts within the EMA’s regulatory network – potentially guiding developers in the right direction when working towards a potential marketing authorisation for their NAM. This feedback, the agency says, will be non-binding and non-decisional.
The EMA plans to accept submissions to the VDS pilot until the third quarter of 2027.
The EMA launches this initiative as part of its efforts to encourage the widespread acceptance and adoption of NAMs, which the agency says can provide information “comparable to, or better than current testing approaches,” while diminishing the need to rely on traditional animal testing procedures in the non-clinical setting.
It would also help the EMA to build further confidence and experience around regulating NAM approaches, the agency says, as data on their use in preclinical research is rarely shared with regulators.
This push from the EMA comes amid wider steps in this direction from global regulators, who are increasingly turning their attention to non-animal testing as the next frontier in non-clinical research. Another key agency leading this charge is the US Food and Drug Administration (FDA), which recently debuted some draft guidance on NAM validation after taking a step back from preclinical primate testing back in December 2025.
Debate on the future of NAMs in non-clinical research continues
While interest in the NAM approach continues to build, their continued use in the non-clinical setting remains an area of hot debate.
In a previous conversation with Clinical Trials Arena, Steve Bulera, CVP and Chief Scientific Officer for Safety Assessment at Charles River Laboratories, noted that NAMs were likely to become the dominant force in preclinical research – though this change will not happen overnight.
Meanwhile, experts in a keynote seminar held by the Westminster Health Forum noted that NAMs will likely play a key role as complementary alternatives to animal testing, rather than replacing their use outright. This is because they are not always able to replicate real human biological systems such as the brain, endocrine, reproductive or immune systems, they commented.
