EMA launches European shortages monitoring platform to tackle persistent medicine shortages

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EMA launches European shortages monitoring platform to tackle persistent medicine shortages

Genéricos/General | Posted 03/12/2024 0 Post your comment

The European Medicines Agency (EMA) launched the European Shortages Monitoring Platform (ESMP) to address persistent medicine shortages across the European Union (EU). This centralized system improves reporting, monitoring, and management, ensuring medicine availability during crises and public health emergencies, and will be mandatory from 2025.

The PGEU Medicines Shortages Report 2023 highlights a growing burden of medicine shortages across Europe, negatively affecting patient trust in the pharmaceutical supply chain. Annual surveys of EU pharmacists reveal that since 2019, all EU countries have reported shortages yearly, with 75% of surveyed countries in 2022 noting a worsening situation compared to the previous year.

To address this persistent challenge, the EMA launched the initial version of the European Shortages Monitoring Platform (ESMP) on 28 November 2024. This platform allows marketing authorisation holders (MAHs) to report shortages of centrally authorised medicines, marking the start of a transition period that will conclude on 2 February 2025, when ESMP usage becomes mandatory.

The ESMP aims to centralise and automate data collection, providing real-time information to improve the monitoring, prevention, and management of shortages across the EU and European Economic Area (EEA). While the initial version focuses on shortage reporting, the second version (to be released in February 2025) will expand its functionalities to include reporting on supply, demand, and availability during crises, supporting EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

Public access to information on medicine shortages will be available through EMA’s and national catalogues. During the transition period, MAHs may continue traditional reporting methods but are encouraged to adopt the platform, with EMA offering training and support resources on its website.

The ESMP is a core component of EMA’s extended mandate under Regulation (EU) 2022/123, designed to improve stakeholder communication and ensure medicine availability during public health emergencies and significant events. Regular updates on the platform are provided via the ESMP webpage.

Drug shortages are not a unique challenge to Europe, Japan, the UK, and the US are also facing a drug shortage crisis and are recommending policy solutions [1-3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Japan’s drug shortage crisis: challenges and policy solutions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/generics/research/japan-s-drug-shortage-crisis-challenges-and-policy-solutions
2. GaBI Online - Generics and Biosimilars Initiative. UK NHS faces drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/es/genericos/general/uk-nhs-faces-drug-shortages
3. GaBI Online - Generics and Biosimilars Initiative. FDA identifies causes of drug shortages, recommends solutions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Dec 3]. Available from: www.gabionline.net/generics/general/FDA-identifies-causes-of-drug-shortages-recommends-solutions

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