The EMA gave initial endorsement to a new approach methodology (NAM) that replaces live animal control groups in early toxicity testing using “virtual” controls derived from historical animal-control data. The endorsement is described as the first formal step that could support future incorporation into marketing approval applications. The move targets a long-standing bottleneck in preclinical safety programs, where animal controls can drive cost, timelines, and variability while contributing limited translational value. For biotech and pharma, the signal suggests that regulatory-accepted NAM frameworks may expand, encouraging sponsors to redesign early tox packages around qualified datasets and pre-built control models rather than repeating animal control cohorts.