The ESMP will be mandatory for MAH’s reporting drug shortages from 2 February 2025. Credit: DreamerAchieverNoraTarvus / Shutterstock.

The first version of the European Shortages Monitoring Platform (ESMP) has gone live to help marketing authorisation holders (MAHs) report shortages of centrally authorised medicines.

Yesterday’s (28 November) launch marks the beginning of a transition which will last until 2 February 2025, after which use of the platform will be mandatory. The second version of the ESMP will be released in the same month, with the full scope of functionalities for MAHs and national competent authorities (NCAs).

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The ESMP will centralise and automate data collection on medicine shortages, enabling regulatory bodies to track medicine availability in an effort to improve the prevention, monitoring, and management of medicine shortages across the European Union (EU) and European Economic Area (EEA). The ESMP is integrated with the European Medicines Agency’s (EMA) data management services to ensure a reliable exchange of information.

The upcoming second version will enable MAHs and NCAs to submit data on the supply, demand and availability of centrally and nationally authorised medicines during crises and preparedness actions. These are led by the EMA executive steering group on shortages and safety of medicinal products (MSSG).

Preparedness actions are taken to monitor and mitigate shortages of a subset of medicines; recent examples include the EMA’s management of the antibiotics shortage in 2023-2024. There have also been global shortages of weight loss drugs, Novo Nordisk’s Wegovy/Ozempic (semaglutide) and Eli Lilly’s Zepbound/Mounjaro (tirzepatide).

The EMA was given a formal, legal role in preparing for, monitoring and managing shortages of medicines in the EU in March 2022. From February 2023, its role was extended to include managing medical device shortages.

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The 2022 EU mandate outlines the EMA’s role as one focussed on the facilitation of information exchange for better prevention, identification and management of shortages, and improved communication between EMA, NCAs and industry stakeholders. The end goal is to ensure medicine availability for EU patients during public health emergencies and major events.

It states that “shortages of medicinal products represent a growing threat to public health, with a serious impact on healthcare systems and on the right of patients to access appropriate medical treatment. Increased global demand for medicinal products, which was exacerbated by the Covid-19 pandemic, has led to further shortages of medicinal products, weakening the healthcare systems in Member States and posing significant risks to patients’ health and to the care of patients…”