WHO Advocates Replacing Animal Testing in Biological Product Quality Control

Following the NIH’s recent move to phase out funding for grant applications relying solely on animal testing, the World Health Organization (WHO) has issued new guidelines titled ‘Guidelines on the replacement or removal of animal tests for the quality control of biological products’. The document emphasizes the 3Rs principle (replace, reduce, refine) and encourages immediate development, validation, and implementation of in vitro, animal-free methods for quality control, even before older WHO documents are updated.

The WHO notes that while animal testing has historically informed product safety, efficacy, and mechanisms of action, modern in vitro approaches are often scientifically superior. The guidelines recommend replacing or removing animal tests wherever feasible, reducing usage where full replacement is not yet possible, and applying Quality by Design principles during product development. Legacy products should be reassessed for the necessity of animal testing in collaboration with regulatory authorities, promoting safer, more ethical, and scientifically robust quality control practices.

22-09-2025