ЕМА запустила пилотный проект по добровольному обмену данными для замены тестов на животных

The European Medicines Agency (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 replace or reduce the use of traditional animal studies in the non-clinical development of medicines. This pilot is part of the EMA’s efforts to foster the regulatory acceptance of NAMs by enabling regulators to gain experience with these approaches and assess their scientific value. NAMs can include complex in vitro systems such as organoids and microphysiological systems, computational models, as well as a combination of multiple methodologies. Ultimately, the initiative aims to strengthen the future use of scientifically robust alternatives to animal testing in regulatory decision-making. It builds on the EMA’s longstanding commitment to the 3Rs principles — replace, reduce and refine the use of animals in medicines development and regulation. Although NAMs are increasingly used in research and early medicine development, data on their use is rarely shared with regulators, limiting the opportunities to build confidence in their regulatory application. The new VDS pilot aims to create a structured, non-binding framework that enables companies, method developers, contract research organisations, academic laboratories and other stakeholders to voluntarily submit and discuss NAM data independent of a marketing authorisation application. Participants will receive individual, non-binding and non-decisional feedback from an operational expert group comprising non-clinical experts from across the European medicines regulatory network. The initiative aims to enhance scientific dialogue, increase regulatory experience with NAMs, promote harmonised assessment approaches across Europe and support the development of a sustainable framework for integrating these innovative methods into medicines regulation. Organisations interested in participating in the new pilot can apply. Following an initial validation process, the selected applicants will be invited to submit a full briefing package for scientific assessment. 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. Published on September 7, 2026