New project aims to advance alternatives to animal testing

The European Medicines Agency (EMA) has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of information generated using New Approach Methodologies (NAMs). These innovative methods have the potential to provide information comparable to, or better than current testing approaches, while helping to replace or reduce the use of traditional animal studies in the non-clinical development of medicines.

The pilot is part of EMA’s efforts to deepen regulatory acceptance of NAMs by enabling regulators to gain experience with these approaches and assess their scientific value in a regulatory context. NAMs can include complex in vitro systems, computational models, as well as a combination of multiple methodologies.

The Agency said this initiative will strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. It builds on EMA’s longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation.

Participants in the VDS pilot will receive individual feedback from an expert group comprising non-clinical experts from across the European medicines regulatory network.

Submissions to the VDS pilot are expected until the third quarter of 2027. At the end of the pilot, EMA will publish a lessons-learned report.