The European Medicines Agency (EMA) has launched a new pilot scheme aimed at giving regulators hands-on experience with innovative methods that could reduce or replace traditional animal testing in the development of medicines.
The voluntary data submission (VDS) pilot will allow companies, researchers, method developers, contract research organisations and academic laboratories to share data generated using New Approach Methodologies (NAMs) with regulators—even when no marketing authorisation application is involved.
NAMs include advanced in vitro technologies such as organoids and microphysiological systems, computational models and combinations of different methodologies. The approaches have the potential to deliver information comparable to, or better than, existing testing methods while reducing reliance on animal studies.
EMA said the initiative is designed to help build confidence in the regulatory value of NAMs, which are increasingly being used in research and early-stage medicine development but are rarely shared with regulators.
That gap has limited regulators’ ability to assess the scientific reliability of NAMs and develop experience in applying them to regulatory decision-making.
Under the new pilot, participants will receive individual, non-binding and non-decisional feedback from an operational expert group made up of non-clinical experts from across the European medicines regulatory network.
EMA expects the initiative to strengthen scientific dialogue between innovators and regulators, build regulatory expertise, encourage more consistent assessment of NAMs across Europe and help establish a sustainable pathway for incorporating these technologies into medicines regulation.
The pilot also builds on EMA’s longstanding commitment to the 3Rs principles—to replace, reduce and refine the use of animals in medicines development and regulation.
Organisations interested in taking part must first submit an application form. Following an initial validation, selected applicants will be invited to provide a full briefing package for scientific assessment.
EMA has published an information document outlining the pilot’s scope, eligibility requirements, submission process and assessment framework.
Applications to the VDS pilot are expected to remain open until the third quarter of 2027. EMA plans to publish a lessons-learned report at the conclusion of the pilot.
The initiative marks a significant step toward testing how scientifically robust alternatives to animal studies can move from research settings into practical regulatory decision-making.
