INN第81号执行摘要

81st Consultation on International Nonproprietary Names for Pharmaceutical Geneva, 14-17 October 2025 Executive Summary International Nonproprietary Names (INN) Programme Product Standards, Specifications and Nomenclature Unit (PSN)Medicines and Health Products Policies and Standards Department (HPS) © World Health Organization 2025 The designations employed and the presentation of the material in this publication do not imply the expressionof any opinion whatsoever on the part of the World Health Organization concerning the legal status of anycountry, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsedor recommended by the World Health Organization in preference to others of a similar nature that are notmentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital All reasonable precautions have been taken by the World Health Organization to verify the informationcontained in this publication. However, the published 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. 81st Consultation on International Nonproprietary Names for Pharmaceutical SubstancesGeneva, 14-17 October 2025 (hybrid face-to-face/virtual meeting) EXECUTIVE SUMMARY WELCOME and OPENING REMARKS Participants were welcomed to the 81st INN Consultation by Mr Deus Mubangizi, Director of theDepartment of Medicines and Health Products Policies and Standards (HPS). He focused his introduction on the re-structuring that has taken place within WHO, of the need toreduce personnel but at the same time maintain the important work of the organisation. HPS is one ofsix departments (down from thirteen) of the division of Health Systems Access and Data headed bythe Assistant Director General Dr Yukiko Nakatani. Within HPS, Dr Raffaella Balocco, has beenelevated to be Unit Head of not only the INN and Classification of Medical Products Unit (now team)but also two other teams, Norms and Standards for Pharmaceuticals (NSP), and Biologicals Normsand Standards and Transplantation (BNT). This brings together three WHO Expert Committees –INN, ECBS and ECSPP, plus the ATC/DDD advisory group – creating the largest normative unit formedicines within WHO. Overall, HPS hosts five of the six active WHO Expert Committees, and With healthcare products being the largest cost in a healthcare system, HPS remains highly important,but nonetheless had to be streamlined. During this process each division had to identify five corefunctions to be retained and the work of the INN impinges on all five HPS priorities but especially on Mr Mubangizi went on to highlight that more than 280 requests including 240 new ones, are to bediscussed in this Consultation. He remarked that INN remains totally important for internationalunderstanding and communication of drugs and that the INN continues to evolve, reflecting a growingneed to maintain consistent naming principles. The new INN protein database is also important and isbecoming an international reference model. Mr Mubangizi expressed his gratitude to fellow staff and Dr Balocco thanked the Director for his remarks and repeated her feeling of gratitude to her INN teamand also to the Experts for their work in staying abreast of all the requests from her. She added thateven with new limitations, WHO is an important organisation, and a privilege to work for. ELECTION of CHAIR, VICE-CHAIRS and RAPPORTEUR Professor Sarel Malan was nominated to chair this Consultation, and this was agreed. Professor Malan then requested the support of Dr Akinola Adisa and Mr Adrian Evans to be co-chairsof biologicals and chemicals respectively, and Dr Jim Roberston to be rapporteur, to which all agreed. Professor Malan was privileged to be Chair and before commencing with the Consultation, requesteda Tour de Table as there were several new members present. NOTES of the 80th INN CONSULTATION The report of the 80th INN Consultation was tabled and adopted by all, and thanks were proffered tothe rapporteur, Dr Robertson. NOMENCLATURE of INN During the 81st INN Consultation, 281 INN requests were discussed, including: •244 new INN requests, of which 136 were for biological substances•34 outstanding requests As a result of these discussions, 269 new names were selected, which are planned to be published inList 135 of proposed INN (p.INN) and COVID-19-related requests only in pending List 134. Threerequests did not fulfil INN criteria (No INN), 4 were withdrawn by the applicant and 5 requests were Four new stems/substems were selected, two suffixes were promoted to the pre-stems list and it wasdecided to review th