Goodbye general animal safety tests

This article reviews the historical use of general animal safety tests in the European Pharmacopoeia, their scientific limitations, and the ethical concerns that have driven their progressive elimination. It highlights the role of the European Pharmacopoeia Commission in implementing the 3Rs principles (Replacement, Reduction, and Refinement) and introducing a fourth 'R', "Removal". Key milestones include the suppression of tests for abnormal toxicity, pyrogens, histamine and depressor substances, culminating in the complete abolition of general animal safety tests by 2026. The article emphasises the scientific superiority of validated in vitro methods, the impact of good manufacturing practices, and the regulatory strategies that ensure product safety without reliance on animal testing. This evolution represents a significant achievement for animal welfare and modern pharmaceutical quality control.