世界卫生组织药品质量认证计划

WHO certification scheme on thequality of pharmaceutical products © World Health Organization 2025Some 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,provided the work is appropriately cited, as indicated below. In any use of this work, there should be nosuggestion that WHO endorses any specific organization, products or services. The use of the WHO logo isnot permitted. If you adapt the work, then you must license your work under the same or equivalent CreativeCommons licence. If you create a translation of this work, you should add the following disclaimer along withthe suggested citation:“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 be the binding andAny 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. WHO certification scheme on the quality of pharmaceutical products. Geneva: World HealthOrganization; 2025.https://doi.org/10.2471/B09336. 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 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 astables, figures or images, it is your responsibility to determine whether permission is needed for that reuse andto obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with theuser.General disclaimers.The designations employed and the presentation of the material in this publication do notimply the expression of any opinion whatsoever on the part of WHO 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 anddashed lines on maps represent approximate border lines for which there may not yet be fullagreement.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 capitalletters.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 responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO beDesign and layout by Inis Communication authentic edition”.liable for damages arising from its use. ContentsAcknowledgements1. Introduction2. Background3. Purpose and evolution of the WHO Certification SchemeEvolution of the SchemeKey changes to the Scheme4. Regulatory ecosystem and other tools5. Experiences from regulatory authorities and industry perspectives5.1 Reflections from National Regulatory Authority of Cuba, Center for State Control of Medicines,Medical Equipment and Devices (CECMED)5.2 European Medicines Agency (EMA)5.3 Singapore Health Sciences Authority (HSA)5.4 Reflections from Industry – International Federation of Pharmaceutical Manufacturersand Associations (IFPMA)6. Strengths and limitations of the Certification Scheme7. The way forwardReferences iiiiv1233456691011141516 ivAcknowledgementsThis publication was a true collaborative effort,and we would like to express our sincere gratitudeto the collaborators for their technical expertiseand dedication developing, writing and revisingthispublication:Dr Samvel Azatyan, Team Lead of RegulatoryConvergence and Networks, WHO headquarters,Geneva, Switzerland.Dr Luther Gwaza, Team Lead of Normsand Standards for Pharmaceuticals, WHOheadquarters, Geneva, Switzerland.Dr Djamila Reis, Technical Officer at RegulatoryConvergence and Networks, WHO headquarters,Geneva, Switzerland.Dr Celeste Sánchez, Head of Policy and RegulatoryAffairs, Center for State Control of Medicines, Medical Equipment and Devices (CECMED),La Habana, Cuba.Ms Virginia Rojo Guerra, Head of the ProceduresOffice, European Medicines Agency (EMA),Amsterdam, TheNetherlands.Ms Alice Lim, Senior Regulatory Specialist,Licensing and Certification Branch, Audit andLicensing Division, Health Products RegulationGroup, Singapore Health Sciences