EMA 启动自愿数据提交试点，推进动物试验的创新替代方法

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, 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 are rarely shared with regulators, limiting 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 independently 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 are invited to submit an application form to express their interest. Following an initial validation process, selected applicants will be invited to submit a full briefing package for scientific assessment. An information document, including details on the scope of the pilot, eligibility criteria, submission requirements and assessment process, is also available.

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.