Europe: EMA launches pilot on New Approach Methodologies to reduce animal testing

The European Medicines Agency (EMA) has introduced a voluntary pilot scheme for data generated through New Approach Methodologies (NAMs). These methods may involve complex in vitro systems, including organoids and microphysiological systems, as well as computational models. They may provide information that is comparable to, or better than that obtained through current testing methods, while contributing to efforts to replace or reduce animal studies in the non-clinical development of medicines. The initiative also builds on EMA’s longstanding commitment to the 3Rs principles – to replace, reduce and refine the use of animals in medicines development and regulation. 

While NAMs are becoming more common in research and early-stage medicine development, such data are still rarely shared with regulators. The pilot is therefore designed to give regulatory authorities more experience with these methods, support the assessment of their scientific value for regulatory purposes and promote scientific dialogue. 

Participants may provide NAM data voluntarily and independently of a marketing authorisation application and will receive individual, non-binding feedback from experts within the European medicines regulatory network. The pilot is also intended to encourage greater consistency in the assessment of NAMs across Europe and contribute to the development of a sustainable framework for their future integration into medicines regulation. 

Data submissions are expected to remain possible until the third quarter of 2027. Once the pilot has concluded, EMA will publish a report summarising the experience and lessons gained.