The EMA gave initial endorsement to a new approach to early toxicity testing designed to replace live animal controls with “virtual counterparts.” The virtual groups are derived from historical control data generated in animals used previously in studies, within a broader EU-funded project that involved 20 pharma and crop science companies. Although the scope described is limited, the development is framed as the first time the EMA formally endorses a new approach methodology that could later be included in marketing authorization applications for toxicity testing. For biopharma, the practical takeaway is a continued regulatory drift toward NAM data packages that can reduce animal usage while preserving evidentiary value—potentially reshaping how early-stage toxicity dossiers are planned and justified.