EMA’s human medicines committee (CHMP) has issued a draft qualification opinion for a new methodology in preclinical research, which can reduce the overall number of animals (rats) used in specific dose-range finding studies. This method replaces standard (concurrent) animal control groups with virtual control groups. By qualifying this new approach methodology (NAM), the CHMP can accept evidence generated using virtual control groups (within the defined context of use) as scientifically valid in future medicines applications.