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.

While the reduction of animal testing will be gradual, this first qualification opinion for a NAM used in the assessment of toxicity, creates a blueprint for future applications. Potential iterations of the NAM could be qualified for use in toxicological studies where control groups are routinely required. Replacing control groups with ‘virtual animals’ in such studies would have a substantial impact on reducing the total numbers of animals…