全球智能药物警戒战略

The global smartpharmacovigilance strategy The global smart pharmacovigilance strategy ISBN978-92-4-011675-7(electronic version)ISBN 978-92-4-011676-4 (print version) © World Health Organization2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO 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 useof this work, there should be no suggestion that WHO endorses any specific organization,products or services. The use of the WHO logo is not permitted. If you adapt the work, then youmust license your work under the same or equivalent Creative Commons licence. If you createa translation of this work, you should add the following disclaimer along with the suggestedcitation:“This translation was not created by the World Health Organization (WHO). WHO is notresponsible for the content or accuracy of this translation. The original English edition shall bethe binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordancewith the mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. The global smart pharmacovigilance strategy. Geneva: World HealthOrganization;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. To submit requests for commercial use and queries on rights andlicensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to athird party, such as tables, figures or images, it is your responsibility to determine whetherpermission is needed for that reuse and to obtain permission from the copyright holder. Therisk of claims resulting from infringement of any third-party-owned component in the work restssolely with the user. General disclaimers.The designations employed and the presentation of the material inthis publication do not imply the expression of any opinion whatsoever on the part of WHOconcerning the legal status of any country, territory, city or area or of its authorities, orconcerning 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 thatthey are endorsed or recommended by WHO in preference to others of a similar nature thatare not mentioned. Errors and omissions excepted, the names of proprietary products aredistinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in thispublication. 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 lieswith the reader. In no event shall WHO be liable for damages arising from its use. Editing, design and layout by Inis Communication Contents Message from the Assistant Director-General,Health Systems, Access and DatavForewordviTo our partnersviiiAcknowledgementsixAbbreviationsxiiGlossaryxiiiExecutive summaryxviIntroduction11. Underlying principles and concepts52. Implementation ofThe global smart pharmacovigilance strategy193. Enhanced safety communication354. Measuring the uptake and impact ofThe global smart pharmacovigilancestrategy375. Applying the principles ofThe global smart pharmacovigilance strategy:case studies from countries41References47Annex 1. Building on the past: pharmacovigilance ecosystem overview51Annex 2. Pandemic preparedness and pharmacovigilance59Annex 3. Key institutions supporting implementation ofThe global smartpharmacovigilance strategy63Annex 4. Approach to content development67 Message from the AssistantDirector-General, HealthSystems, Access and Data Nobody should be harmed when seeking care. Our collective efforts to strengthenhealth systems must include effective measures to ensure the safety of medicines andother health technologies. This is especially important in the current context of multiplecomplex challenges, limited resources, and competing priorities. This document,The global smart pharmacovigilance strategy,provides evidence-based information to support Member States to address their most pressing healthcare needs while building robust, resilient and lasting pharmacovigilance systems. Itcomplements the WHO Programme for International Drug Monitoring. Drawing on products and programmes such as these, all of us have a role to play – frompatients and their families to hea