EMA Announces Drug Monitoring Platform
A new platform allowing market authorization holders to report drug shortages has gone live.
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The European Medicines Agency (EMA) reported on Nov. 28, 2024 that the European Shortages Monitoring Platform (ESMP) is now live with core functionalities. ESMP enables marketing authorization holders (MAHs) to submit data to report shortages of centrally authorized medicines in the European Union on a routine basis. Use of ESMP will become mandatory on Feb. 2, 2025, per Regulation 2022/123, which facilitates the exchange of information to prevent drug shortages in the EU.
A second version of the ESMP will be released in February 2025 and will include full functionality for MAHs and national competent authorities to submit data on supply, demand, and availability of centrally and nationally authorized drugs during crises actions set forth by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). These types of actions are taken by MSSG to monitor and mitigate potential shortages of important medicines.
“The release of the ESMP is a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most,” the agency stated in a press release (1). “It will centralize and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the EU and the European Economic Area (EEA).”
MAHs are encouraged to become familiar with the ESMP before it becomes mandatory. EMA is offering training, webinars, and information material on its website. The agency will also be providing updates on timelines and developments on its website at https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform
More information about drug shortages in the EU can be found on EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party webpage (2). SPOC monitors and reports on events that may impact the drug supply in the EU. Information on ongoing and resolved shortages can be found on the webpage as well as registries of shortages by EU Member State. The agency lists 30 drugs as currently short in supply.
Drug shortages can be caused by a variety of problems, including quality control issues at manufacturing plants, high product demand, and natural disasters across the world. In June 2024, EMA and the Heads of Medicines Agencies issued recommendations to address the shortage of glucagon-like peptide-1 (GLP-1) receptor agonists due to a surge in demand (3).
“Member States should consider, jointly with marketing authorization holders, measures to control and optimize the distribution of these medicines. Member States’ continuous collaboration and cooperation through the [SPOC] will allow the MSSG to gain a comprehensive overview of the situation and assess the impact of the measures taken. Member States are also encouraged (together with experts and learned societies) to develop guidelines to facilitate prioritization of patients who have the greatest need for the medicines,” the agency stated in the release (3).
In late 2024, a series of intense storms hit the United States, causing damage to manufacturing facilities (4). Baxter had to close its facility in North Carolina, which is the largest manufacturing site for intravenous and peritoneal dialysis solutions in the US (5,6).
References
- EMA. European Shortages Monitoring Platform Enables Better Monitoring of Shortages in the EU. Press Release. Nov. 28, 2024.
- EMA. Medicine Shortages Single Point of Contact (SPOC) Working Party. https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party (accessed Dec. 3, 2024).
- Hennessy, M. Weathering the Storms. Pharmaceutical Technology 2024. 48 (11).
- Baxter. Baxter Provides Update on North Cove, N.C., Facility and Hurricane Helene Relief Plans for Community. Press Release, Sep. 29, 2024.
- Baxter. Hurricane Helene Updates. Press Release, Oct. 21, 2024.
