世界卫生组织国家药品质量控制实验室全球网络：首次会议报告，巴西里约热内卢，2024年10月1日至3日

First meeting report, Rio de Janeiro, Brazil1–3 October 2024 WHO Global Network of NationalQuality Control Laboratories forPharmaceuticals First meeting report, Rio de Janeiro, Brazil1–3 October 2024 WHO Global Network of National Quality Control Laboratories for Pharmaceuticals: first meeting report, Rio de Janeiro,Brazil, 1–3 October 2024 ISBN 978-92-4-010522-5 (electronic version)ISBN 978-92-4-010523-2 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike3.0IGO licence (CCBY-NC-SA3.0IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, providedthe work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHOendorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adaptthe work, then you must license your work under the same or equivalent Creative Commons licence. If you create atranslation of this work, you should add the following disclaimer along with the suggested citation: “This translationwas not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of thistranslation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rulesof the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. WHO Global Network of National Quality Control Laboratories for Pharmaceuticals: firstmeeting report, Rio de Janeiro, Brazil, 1–3 October 2024. Geneva: World Health Organization; 2025. Licence:CCBY-NC-SA3.0IGO. Cataloguing-in-Publication (CIP) data.CIP data are available athttps://iris.who.int/. Sales, rights and licensing.To purchase WHO publications, seehttps://www.who.int/publications/book-orders. Tosubmit requests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such as tables,figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtainpermission from the copyright holder. The risk of claims resulting from infringement of any third-party-ownedcomponent in the work rests solely with the user. General disclaimers.The designations employed and the presentation of the material in this publication do not implythe expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city orarea or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on mapsrepresent 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 endorsedor recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However,the published material is being distributed without warranty of any kind, either expressed or implied. The responsibilityfor the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arisingfrom its use. This publication contains the report of the firstmeeting of the WHO Global Network of National Quality ControlLaboratories for Pharmaceuticals and does not necessarily represent the decisions or policies of WHO. Cover photos: Based on Adobe Stock AI-generated assets. Further developed with the use of generative AI tools. Contents Abbreviations and acronymsvExecutive summaryvi1.Opening and welcome12.Official presentation of WHO-GNP32.1Objectives of the Network and its membership32.2Sharing of information: the SharePoint site of WHO-GNP33.Expectations of potential members of WHO-GNP54.Updates from WHO64.1GPPQCL: updates on the new version, current activities and impacts on quality controllaboratories and other guidance64.2WHO prequalification: impact of the new version of the good practices on inspections74.3Laboratory Networks and Services team: updates on regulatory strengthening activitiesand capacity-building74.4GBT and WLA84.5Summary of discussions95.Challenges for NQCLs: networking, reliance and recognition mechanisms115.1Current experience in networking: the General European Official Medicines ControlLaboratory Network115.2Current experience in networking: the South-East Asia Regulatory Network125.3Current experience in networking: the African Medicines Quality Forum1