Guidelines on the replacement or removal of animal tests for the quality control of biological products

Overview

Adopted on the recommendation of the Eighty-first meeting of the World Health Organization Expert Committee on Biological Standardization, 13–16 October 2025. This finalized and edited document is being provided here prior to its formal publication both as a standalone resource in the WHO Institutional Repository for Information Sharing (IRIS) and as Annex 2 of the full report of the above meeting which will appear in the WHO Technical Report Series.