WHO Issues New Guidelines to Phase Out Animal Testing in Biological Product Quality Control

Following the NIH’s recent decision to stop funding research projects relying solely on animal experiments, the World Health Organization (WHO) has published its Guidelines on the replacement or removal of animal tests for the quality control of biological products. The document stresses that recommendations for adopting in vitro methods take precedence over older WHO requirements, urging manufacturers, developers, and regulators to prioritize validated, animal-free approaches without delay.

The guidance highlights that while animal tests historically played a central role in assessing safety and efficacy, they are now often deemed less reliable than modern in vitro techniques. Since 2019, the WHO has systematically reviewed animal-based testing requirements, identifying alternatives for potency, pyrogenicity, and neurovirulence assessments. The new framework emphasizes the 3Rs principle—replacement, reduction, and refinement—and encourages early integration of in vitro tests, particularly under Quality by Design strategies. Legacy products remain challenging, but WHO calls for close collaboration with regulatory authorities to accelerate the transition.

03-09-2025