会议报告：关于世界卫生组织关于世界卫生组织国际生物参考制剂的制备、鉴定、建立和使用的建议的非正式协商，虚拟会议

Informal consultation on WHO Recommendations for thepreparation, characterization, establishment and use of Virtual meeting 22-24 September 2025 Overview In response to requests from the field, WHO initiated the revision of Annex 2 of WHO TechnicalReport Series No. 932 to update the Recommendations on the preparation, characterization,establishment and use of international biological reference preparations (IBRP), reflectingscientific and regulatory advances since the previous revision in 2004. Following expertdrafting group work and a first round of public consultation, a fourth draft of the revisedRecommendations was developed. To further refine the document and obtain feedback fromstakeholders, WHO convened a virtual informal consultation on 22–24 September 2025 withrepresentatives from regulatory authorities, manufacturers, pharmacopoeias, standard-setting Session I: Opening of the meeting The meeting was opened by Dr Ivana Knezevic (WHO), who delivered the welcoming remarks.Dr Paul Stickings (Medicines and Healthcare products Regulatory Agency) served as chair, andDr Micha Nübling (consultant) acted as rapporteur. Dr Tiequn Zhou (WHO) informedparticipants that the assessment of the WHO Declarations of Interest had identified no potentialconflicts of interest. She then introduced the background, objectives and expected outcomes ofthe meeting. WHO has played a key role for more than 70 years in establishing the internationalbiologicalreference preparations(IBRP)to standardize vaccines and other biologicalsubstances,and in developing WHO written standards(such as guidelines andrecommendations) to ensure the quality, safety and efficacy of biological products. WHOprovidesbiological reference preparations to scientific communities,manufacturers ofbiological products, and national control laboratories around the world, which serve as The use of IBRP has played a critical role in ensuring the quality of biological products overthe past decades; however, the concepts, types, uses and other aspects of these preparations testingof biological products.Important issues and questions have been raised fromstakeholders on various occasions regarding the rationale, selection, development, distributionand use of reference preparations, for example: global harmonization of terminology, responseto public health emergencies, commutability, stability testing, assignment of unitage to different WHO has been requested to revise the current Recommendations [1] to provide harmonized,up-to-date information to guide the development and use of IBRP, particularly InternationalStandards (IS). In 2024, WHO initiated the revision of Annex 2 of the WHO TRS No. 932,including engagement of experts to review existing relevant documents and information,identify key issues, and conduct informal discussions with WHO Collaborating Centers andcustodianlaboratories. A drafting group,composed of experts from WHO custodianlaboratories and WHO Collaborating Centers, was convened by WHO and worked intensivelyon the revision of the document through physical and virtual meeting(s). A series of drafts were Invited participants in the meeting included representatives from manufacturers, nationalregulatory authorities, pharmacopoeias, standard-setting bodies, and international alliances,societies, and expert groups involved in standards and standardization activities. The objectivesof this meeting were: to exchange perspectives from stakeholders on the subject including therole and use of WHO IBRP; to review Draft 4 of the Recommendations for the preparation,characterization, establishment and use of WHO IBRP; and to discuss key issues from the first In the capacity of the Secretary of the Expert Committee on Biological Standardization (ECBS),Dr Knezevic gave an update on the recent and future WHO activities in the area of biologicals.Biological standardization is one of the core activities defined in WHO constitution [2]. Thework is accomplished through WHO biological programme, WHO Collaborating Centers, andthe WHO ECBS. This work also involves close collaboration with international scientific andprofessional communities, regional and national regulatory authorities, manufacturers, andexpert laboratories worldwide. Updates on organizational changes at WHO were presented. In SessionII:Perspectives from regulators,manufacturers and otherstakeholders on the role and use of WHO international standards Dr Mihaela Buda (European Directorate for the Quality of Medicines and HealthCare, EDQM)presented a brief introduction to the European Pharmacopoeia and highlighted key aspectsrelated to the establishment and role of the Ph. Eur. Reference Standards. She focused on theEDQM’s work in the field of WHO IS for antibiotics and provided an update on the EDQM’sBiological Standardization Programme, with focus on projects related to the establishment ofPh. Eur. Biological Reference Preparations (BRP). Regarding the topic of this meeting Dr Budaemphasize