缩小在获得儿童友好型基本药物制剂方面的差距

Towards closingthe gap in access Some 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, thereshould be no suggestion that WHO endorses any specific organization, products or services. The useof the WHO logo is not permitted. If you adapt the work, then you must license your work under the Any mediation relating to disputes arising under the licence shall be conducted in accordance withthe mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/ Suggested citation. Towards closing the gap in access to child-friendly formulations of essentialmedicines. Geneva: World Health Organization; 2025.https://doi.org/10.2471/B09623. 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,such as tables, figures or images, it is your responsibility to determine whether permission is neededfor that reuse and to obtain permission from the copyright holder. The risk of claims resulting from General disclaimers. The designations employed and the presentation of the material in thispublication do not imply the expression of any opinion whatsoever on the part of WHO concerningthe legal status of any country, territory, city or area or of its authorities, or concerning the The mention of specific companies or of certain manufacturers’ products does not imply that theyare endorsed or recommended by WHO in preference to others of a similar nature that are notmentioned. Errors and omissions excepted, the names of proprietary products are distinguished by 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, eitherexpressed or implied. The responsibility for the interpretation and use of the material lies with the Cover image: © WHO / Zakarya SafariDesign and layout by 400 Communications Limited. Contents AcknowledgementsivAcronyms1Background2The needs and gaps perceived by health-care workers4The current market landscape for child-friendly formulations4Review of the age-appropriateness of medicines listedin the existing WHO EMLc4Informing PADO11Next steps for GAP-f: our shared path forward13References14Annex 1. Paediatric quality target product profileattributes and targets17Annex 2. Paediatric quality target product profile tool scoring criteria19 Acknowledgements The body of work summarized in this technicalreport was led by the WHO Essential MedicinesSecretariat with contribution from the GlobalAccelerator for Paediatric FormulationsSecretariat in the WHO Science Division. AsmaHafiz and Tiziana Masini led the writing of thisreport with input from Bernadette Cappello and the Clinton Health Access Initiative for theircontribution to the overall project. WHO wouldalso like to acknowledge Emelyne Gres (Penta This report is based on a project funded by theGates Foundation. The findings and conclusions Acronyms EMLWHO Model List of Essential MedicinesEMLcWHO Model List of Essential Medicinesfor ChildrenGAP-fGlobal Accelerator for Paediatric Background Ensuring that all children have access to safe,effective and age-appropriate medicinesis a global health imperative. The vision isthat paediatric formulations exist for a muchwider range of diseases and conditions andthat these formulations are widely available To address these challenges, WHOestablished the Global Accelerator forPaediatric Formulations (GAP-f)(10)in 2020, building on the political commitment of the2016 World Health Assembly resolution(11)that emphasized the need for innovationand access to quality, safe, effective andaffordable medicines for children across theproduct life cycle. Hosted within the WHO Although regulatory incentives andincreased investment from researchers and public–private partnerships have sought toadvance paediatric formulation development(1–3), a critical gap persists: the globalavailability of age-appropriate medicines forchildren remains limited, especially in low-and middle-income countries(4,5). Globally,only one third of countries include paediatricformulations in national essential medicines A cornerstone of this effort within WHO isthe Model List of Essential Medicines forChildren (EMLc)(12), first published in 2007and updated biennially –