WHO Expert Committee on Biological Standardization: eighty-first report

The eighty-first report of the WHO Expert Committee on Biological Standardization presents the deliberations and recommendations arising from the Committee’s meeting held in October 2025. It reviews strategic developments in the standardization of biological products, including vaccines, biotherapeutics, blood products, in vitro diagnostics, and cell and gene therapy products, and outlines progress in the development and implementation of WHO written standards and international biological reference materials to support their quality, safety and efficacy.

The report documents the Committee’s consideration and adoption of new and revised WHO guidelines and international standards, including guidance on replacing or removing animal tests for the quality control of biological products. It also summarizes the establishment of new WHO international reference standards and reference reagents, proposed future standardization projects, and priorities for the revision and development of WHO recommendations. The report highlights the importance of international collaboration, regulatory convergence and scientifically robust reference materials in promoting harmonized evaluation, manufacture and quality control of biological products and supporting equitable global access to safe and effective health technologies.