EU: EMA consults on virtual control groups to reduce animal use in medicines development

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has released a draft qualification opinion on a novel methodology in preclinical research that has the potential to lower the number of animals, specifically rats, required in certain dose-range finding studies. Specifically, this method uses virtual control groups which are created by analysing existing control data and selecting suitable “virtual comparator animals” to match those receiving treatment. According to the EMA, integrating novel approach methodologies (NAMs) such as virtual control groups could not only decrease the number of animals required in non-clinical studies but also improve the scientific relevance and predictability of testing. The consultation, open from today until 12 May 2026, invites input from the scientific community and stakeholders.