监管和资格预审部，《2025-2028年战略行动计划》

Department of Regulationand PrequalificationStrategic action plan 2025–2028 © World Health Organization 2025Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO;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-commercialpurposes, provided the work is appropriately cited, as indicated below. In any use of this work, there shouldbe no suggestion that WHO endorses any specific organization, products or services. The use of the WHOlogo is not permitted. If you adapt the work, then you must license your work under the same or equivalentCreative Commons licence. If you create a translation of this work, you should add the following disclaimeralong with the suggested citation: “This translation was not created by the World Health Organization(WHO). WHO is not responsible for the content or accuracy of this translation. The original English editionshall be the binding and authentic edition”.Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediationrules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/).Suggested citation.Department of Regulation and Prequalification: strategic action plan 2025–2028.Geneva: World Health Organization; 2025.https://doi.org/10.2471/B09421. Licence:CC BY-NC-SA 3.0 IGO.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.To submit 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, suchas tables, figures or images, it is your responsibility to determine whether permission is needed for thatreuse and to obtain permission from the copyright holder. The risk of claims resulting from infringementof any third-party-owned component in the work rests solely with the user.General disclaimers.The designations employed and the presentation of the material in this publicationdo not imply the expression of any opinion whatsoever on the part of WHO concerning the legal statusof any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiersor boundaries. Dotted and dashed lines on maps represent approximate border lines for which thereThe mention of specific companies or of certain manufacturers’ products does not imply that they areendorsed or recommended by WHO 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 WHO to verify the information contained in this publication.However, the published material is being distributed without warranty of any kind, either expressed orimplied. The responsibility for the interpretation and use of the material lies with the reader. In no eventshall WHO be liable for damages arising from its use. may not yet be full agreement. ContentsForewordAcknowledgementsAbbreviationsExecutive summaryIntroduction to WHO’s Department of Regulation and PrequalificationEnvironmental landscapeCall to actionStrategic priorities and objectivesMeasuring impact and resultsMoving the agenda forwardReferences ivvvivii16810222628iii Forewordas disparities in access to essential health products continue to widen. Strengthening regulatory systems,therefore, is not just a technical priority but an ethical imperative. Our 2025–2028 plan outlines targetedstrategies and activities to achieve these goals.We will enhance partnerships across sectors, advance innovative solutions not only to support thedevelopment of regulatory systems but solutions to encourage health product developers and manufacturersto bring forth new innovative technologies. In doing so, we will enable the World Health Organization (WHO)to better meet the needs of vulnerable populations globally and prequalify products to provide access(to specific countries which lack the systems in place to provide quality assured health products). These effortsare designed not only to improve access but to reinforce public trust in health products – a crucial componentin achieving our mission of health equity.As long as prequalification will be needed, it will have to continuously evolve, adapting to new circumstancesand promoting public health, through quality-assured, safe and effective, equitable and affordable access tohealth and medical products.I am grateful to our dedicated team, partnersand stakeholders worldwide for their ongoingcommitment and collaboration. Together, weare forging a future where safe, effective andaffordable health products are within r