The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.