FDA endorsement of animal-replacement toxicity testing is moving from policy to practice. The EMA is poised to approve its first “new approach methodology” (NAM) to replace live animal controls in toxicity studies, with virtual control groups derived from historical datasets. The framework is being compiled in an EU-funded project involving 20 pharma and crop-science companies. While the scope is limited, it marks the first formal EMA step that could allow NAM-generated evidence to feed into marketing-approval applications—reducing reliance on live controls in early safety work.