EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data 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.

This pilot is part of EMA’s efforts to foster the 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 such as organoids and microphysiological systems, computational models, as well as a combination of multiple methodologies. Ultimately, this initiative aims to 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,…