European Medicines Agency launches pilot to reduce animal testing

The European Medicines Agency (EMA) has launched a pilot program to promote the use of New Approach Methodologies (NAMs) as alternatives to animal testing in the pre-clinical development of medicines. This initiative, known as the Voluntary Data Submission (VDS) program, encourages companies, academic laboratories, and developers to share data obtained through innovative techniques.

These methodologies include organoids, microphysiological systems, and computational models. The EMA notes that these innovative methods have the potential to provide information that is comparable to, or even superior to, current animal testing approaches. The program aims to foster regulatory acceptance by allowing regulators to gain experience with these methods and evaluate their scientific value in a regulatory context.

Participation in the pilot is voluntary and occurs outside of formal marketing authorization applications, ensuring that the process does not delay product approvals. Participants will receive individual, non-binding scientific feedback from a group of non-clinical experts. The call for participation remains open until September 2027.