{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T12:58:04Z","timestamp":1784552284206,"version":"3.55.0"},"reference-count":28,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:00:00Z","timestamp":1759795200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:p>Shortages of medicines are a global public health challenge with a significant impact on patient care. While the issue is at the top of the agenda of EU policymakers, regulators and healthcare providers, shortages are a complex problem with many contributing factors requiring multifaceted solutions. This article is a reflection of the work EMA and network of EU regulatory agencies for medicines carried out since 2012, in particular its taskforce, set up in 2016 to provide strategic and structural solutions to tackle shortages in the EU. Since its inception, the taskforce played a key role in spearheading activities related to medicines\u2019 shortages. Members of the taskforce supported important initiatives from leading the work on critical medicines to laying the foundation for Regulation (EU) 2022\/123, which reinforces EMA\u2019s role in crisis preparedness and management of medicinal products and medical devices. On 18 December 2024 the taskforce reached the end of its mandate. Its work is now integrated into EMA and HMA\u2019s core activities. Future activities such as the implementation of shortage prevention plans will be further defined by measures in the revised pharmaceutical legislation, and the proposed Critical Medicines Act.<\/jats:p>","DOI":"10.3389\/fpubh.2025.1673681","type":"journal-article","created":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T11:43:35Z","timestamp":1759837415000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe"],"prefix":"10.3389","volume":"13","author":[{"given":"Inga","family":"Abed","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Bennett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brendan","family":"Cuddy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Dang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Garc\u00eda Burgos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domenico","family":"Di Giorgio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Lamas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Momir","family":"Radulovic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuno","family":"Sim\u00f5es","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui","family":"Santos Ivo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugues","family":"Malonne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Dias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,10,7]]},"reference":[{"key":"ref1","volume-title":"The shortage economy","year":"2021"},{"key":"ref2","volume-title":"Reflection paper on medicinal product supply shortages caused by manufacturing\/good manufacturing practice compliance problems","year":"2012"},{"key":"ref3","volume-title":"EU medicines agencies network strategy to 2020 - working together to improve health","year":"2015"},{"key":"ref4","volume-title":"Reform of the EU pharmaceutical legislation","year":"2023"},{"key":"ref5","volume-title":"Structured dialogue on security of medicines supply","year":"2021"},{"key":"ref6","volume-title":"Regulation (EU) 2022\/123 of the European Parliament and of the council of 25 January 2022 on a reinforced role for the European medicines agency in crisis preparedness and management for medicinal products and medical devices","year":"2022"},{"key":"ref7","year":""},{"key":"ref8","volume-title":"Guidance on detection and notification of shortages of medicinal products for marketing authorisation holders (MAHs) in the union (EEA)","year":"2019"},{"key":"ref9","volume-title":"European shortages monitoring platform","year":""},{"key":"ref10","volume-title":"EMA takes further steps to address critical shortages of medicines in the EU","year":"2023"},{"key":"ref11","volume-title":"Good practices for industry for the prevention of human medicinal product shortages","year":"2023"},{"key":"ref12","volume-title":"Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use","year":"2022"},{"key":"ref13","volume-title":"CA15105 - European medicines shortages research network - addressing supply problems to patients (medicines shortages)","year":""},{"key":"ref14","volume-title":"Risk management plans to mitigate the potential for drug shortages - guidance for industry","year":"2022"},{"key":"ref15","volume-title":"Drug shortages - an exploration of the relationship between U.S. market forces and sterile injectable pharmaceutical products: interviews with 10 pharmaceutical companies","year":"2017"},{"key":"ref16","volume-title":"Communication from the commission to the European Parliament, the council, the European economic and social committee and the Committee of the Regions - addressing medicines shortages","year":"2023"},{"key":"ref17","volume-title":"The European Commission. Proposal for a regulation of the European Parliament and of the council laying down union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European medicines agency, amending regulation (EC) no 1394\/2007 and regulation (EU) no 536\/2014 and repealing regulation (EC) no 726\/2004, regulation (EC) no 141\/2000 and regulation (EC) no 1901\/2006","year":"2023"},{"key":"ref18","volume-title":"Good practice guidance for communication to the public on medicines\u2019 availability issues - recommendations for EU national competent authorities and EMA to ensure adequate public information","year":"2019"},{"key":"ref19","volume-title":"Public information on medicine shortages","year":"2025"},{"key":"ref20","volume-title":"Feedback from surveys to patients, healthcare professionals and National Competent Authorities on communication of recent medicine shortages, joint PCWP\/HCPWP plenary meeting","year":"2023"},{"key":"ref21","volume-title":"Moving together towards better prevention of medicine shortages in the EU \u2013 Feedback from the HMA\/EMA multistakeholder workshop on shortages","year":"2023"},{"key":"ref22","volume-title":"HMA\/EMA workshop on availability of authorised medicines","year":"2019"},{"key":"ref23","volume-title":"Shortages of medicines in OECD countries. OECD health working papers","author":"Chapman","year":"2022"},{"key":"ref24","volume-title":"Union list of critical medicines","year":"2024"},{"key":"ref25","volume-title":"Commission staff working document - vulnerabilities of the global supply chains of medicines - structured dialogue on the security of medicines supply","year":"2022"},{"key":"ref26","volume-title":"Future-proofing pharmaceutical legislation \u2013 Study on medicine shortages \u2013 Final report (revised). European Commission, directorate-general for health and food safety, Luxembourg: Publications Office of the European Union","author":"De Jongh","year":"2021"},{"key":"ref27","year":""},{"key":"ref28","volume-title":"Critical medicines act","year":"2025"}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1673681\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T11:43:36Z","timestamp":1759837416000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2025.1673681\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,7]]},"references-count":28,"alternative-id":["10.3389\/fpubh.2025.1673681"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2025.1673681","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,7]]},"article-number":"1673681"}}