世界卫生组织_生物制品质量控制中动物试验的替换或移除指南

Guidelines on the replacement or removal of animal tests for the quality control of biological products 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. © World Health Organization 2025 All rights reserved. The designations employed and the presentation of the material in this document do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this document. However, the material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors [or editors as appropriate] alone are responsible for the views expressed herein. Annex 2 Guidelines on the replacement or removal of animal tests for the quality control of biological products 1. Introduction 4 2. Purpose and scope 5 3. Terminology 6 4. General considerations 7 5. Adventitious agent testing 10 5.1 In vivo adventitious agent testing 10 5.2 Test for haemadsorbing and haemagglutinating viruses 10 5.3 Test for mycobacteria 11 5.4 Test for avian viruses 11 5.5 Conclusions 11 6. Pyrogenicity and endotoxin testing 12 6.1 Pyrogenicity testing 12 6.2 Endotoxin testing 14 6.3 Conclusions 15 7. Neurovirulence testing 15 7.1 Yellow fever vaccine 16 7.2 Oral poliomyelitis vaccine 17 7.3 Mumps vaccine 19 7.4 Other viral vaccines 19 7.5 Conclusions 20 8. Potency testing 20 8.1 Conclusions 23 9. Specific toxicity 24 9.1 Diphtheria, tetanus and acellular pertussis vaccines 24 9.2 Polysaccharide vaccines conjugated to a diphtheria or tetanus toxoid carrier protein 2