Meeting report: Informal consultation on WHO Recommendations for the preparation, characterization, establishment and use of WHO international biological reference preparations, Virtual meeting

Overview

In response to requests from the field, WHO initiated the revision of Annex 2 of WHO Technical Report Series No. 932 to update the Recommendations on the preparation, characterization, establishment and use of international biological reference preparations (IBRP), reflecting scientific and regulatory advances since the previous revision in 2004. Following expert drafting group work and a first round of public consultation, a fourth draft of the revised Recommendations was developed. To further refine the document and obtain feedback from stakeholders, WHO convened a virtual informal consultation on 22–24 September 2025 with representatives from regulatory authorities, manufacturers, pharmacopoeias, standard-setting bodies and other stakeholders. Participants exchanged perspectives on the use of WHO IBRP, reviewed the draft document and discussed key issues requiring clarification, including terminology, principles of biological standardization, metrological aspects, commutability, and lifecycle considerations for IBRP, as well as the responsibilities of users, including manufacturers.