The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot program to allow drug developers to share data generated by new approach methodologies (NAMs). This initiative is designed to help regulators gain experience with alternative testing methods and assess their scientific value within a regulatory context, potentially reducing the necessity for traditional animal studies during the drug development process. By establishing this structured, non-binding framework, the EMA aims to foster the regulatory acceptance of NAMs and strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. The pilot builds on the agency’s longstanding commitment to the 3Rs principles—to replace, reduce, and refine the use of animals in medicines regulation.
Currently, NAMs such as organoids, microphysiological systems, and computational models are increasingly used in early drug research, but the resulting information is rarely shared with regulators. This lack of information sharing has limited the ability of authorities to build confidence in these methods for formal regulatory applications. Through the new NAM data submission pilot, companies, contract research organizations, and academic laboratories can discuss NAM data independently of a marketing authorization application. Participants will receive non-binding feedback from an expert group comprising non-clinical specialists across the European regulatory network. This scientific dialogue is intended to promote harmonized assessment approaches and support a sustainable framework for integrating innovative methods into medicines regulation.
The launch follows similar global efforts to reduce reliance on animal testing. In March, the U.S. Food and Drug Administration (FDA) published draft guidance to assist sponsors in transitioning to non-animal alternatives, while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on reviewing clinical trial applications that utilize non-animal data. Additionally, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recently proposed a method using virtual control groups in rat dose-range-finding studies to replace concurrent animal control groups. Stakeholders can express interest in the NAM data submission pilot through the third quarter of 2027, after which the EMA intends to publish a report detailing the lessons learned from the program.
