世界卫生组织生物标准化专家委员会2025年10月13日至16日会议的主要成果

The81stmeeting of the WHO Expert Committee on Biological Standardization (ECBS) washeld from13to16October2025as a hybrid meeting.ECBSmembersmetin personat theWHO TrainingCentre in Tunis, with other participants attending virtually.The ECBSdiscussedabroadrange ofcurrentissuesin relation tothe quality, safety and efficacy ofbiologicalproducts used in medicine,and was updated on theactivitiesofthecustodianlaboratories forthe highly specializedWHOmeasurementstandardsused in this field.Prior tothe main meeting, anopen information-sharing sessionwas held on Monday 13 October 2025thatincluded representatives ofnon-state actors, intergovernmental organizations and otherentities.ECBS members, regulatory authority representatives and subject matter experts fromgovernmental organizationsthenparticipated in themainmeeting from Monday 13 October toWednesday 15 October 2025.All ECBS decisions and recommendations regarding theestablishment ofnew and replacementWHOmeasurement standards, as well as theadoptionof WHOpublished guidance documents,were madeduringa closed session held onThursday16October2025attended only by ECBS members andtheWHOsecretariat.At the end of theclosed session, theECBS providedits feedbackand recommendationsto WHO.Afullmeetingreportwill be published in the WHO Technical Report Seriesin 2026. The mainmeetingoutcomesincluded theECBSrecommendation toadopt the following WHOdocument: •WHO Guidelineson thereplacementorremovalof animal tests for the quality controlof biological products Animal tests havelongplayed a part in thequality control and lot release ofbiological products.However, theirinherent variability and poor precisionis increasingly renderingsuch testsinferior towell-designed non-animal in vitro assays for monitoring product quality andproduction consistency,and for assessing the potential consequences of manufacturingchanges.As part ofitscontinuing and concerted efforts in this area,WHOconvened an expertdraftinggroup todevelopoverarchingguidance on the replacement or removal ofanimal teststhat will nowsupersedetherelevantrecommendationsprovidedinpreviously publishedWHOdocuments.Thisimportant new document has been aligned with current thinking amongregulators worldwide,and reinforces WHO’s commitment to support manufacturers andregulators of biological productsin accelerating theimplementation ofnon-animalin vitroalternatives toanimal-based quality controlapproacheswhenever scientificallyjustified. Asshownin Table 1, the ECBSalsorecommended the establishment ofsixreplacementand11newWHO international referencestandards. As well asrecommendingthe adoption of theaboveWHOGuidelinesandtheestablishmentofthe17 internationalreferencestandardsshownin Table 1, theECBSalsodiscussedthefollowing: 1.A core functionenshrined inthe WHOConstitutionis to develop, establish and promotethe use ofinternational standards. Such standardsinclude the international referencestandardsthat form the basis ofnationalregulationofvitally neededbiologicalproductsandin vitrodiagnostics.The Committee was updated onthe progress made inrevisingtheWHORecommendations for the preparation,characterization and establishment ofinternational and other biological reference standards.Reflecting both the considerabletechnological advancesmadein recent years in the manufacturing and testing of biologicalproducts,andtheincreasing range,useand demand forthe associatedWHO internationalreference standards, the revised document willcontinue tobe thefoundational documentin guiding the work of WHO,itscustodian laboratories and other key stakeholders in thisfield. TheECBScommended the progress that had been made andlooked forward toreviewing the documentwith a view to recommending its adoptionat its next meetinginApril 2026. 2.WHO Recommendations,Guidelines and other published guidance documents onbiological productsunderpin thevital WHOprequalification process,and are aninvaluableresource for product developers,manufacturers and regulators, especially in low-andmiddle-income countries.Faced with unprecedented demand forthese highly resource-intensive but crucially needed products, WHO continues to promote transparency aroundthe process used to prioritize their development. The ECBS reviewed the prioritiespresentedfor forthcomingWHO publications in the context oftheirglobal public healthimportance.Highlightedpriorities included the need for published WHO guidance onnewtuberculosisvaccinesandoncell-basedyellowfever vaccines, along with a recognizedneed for ECBS inputs andsubsequentpublished WHO guidance in the coming years on thedevelopment of poliomyelitisvaccines based on virus-like particles. 3.The development of polysaccharide conjugate vaccines continues to represent a keystrategy in protecting infants and young children against a range of pathogens associatedwith considerable public health burdens, particularly in low-and middle-income countries.With regard to the need for specific WHO guidance in this area, the ECBS noted that anumbe