The European Medicines Agency (EMA) provided initial endorsement for a new approach methodology (NAM) intended to replace live animal control groups in early toxicity testing. The method uses “virtual control groups” derived from historical animal-control datasets generated in previous studies. EMA’s support positions the approach as the first NAM formally endorsed that could, in future applications, be included in marketing authorization submissions. While the endorsement is limited in scope, it represents a practical regulatory pathway for integrating non-animal control data into toxicology packages. The virtual control database was assembled through an EU-funded project with contributions from 20 pharmaceutical and crop science companies. For biotech developers, this is a concrete signal that EU regulators are willing to accept parts of the toxicology evidence package that reduce the need for concurrent animal controls—an operational shift with potential impacts on timelines and study design costs.