New Pharmaceutical Shortages Surveillance Platform in Europe
The new system for reporting medication shortages by holders of market authorizations is now active
With the launch of its primary functions, the European Shortages Monitoring Platform (ESMP) was announced by the European Medicines Agency (EMA) on November 28, 2024. With the help of ESMP, MAHs can regularly report shortages of centrally authorized medications in the EU by submitting data. In order to avoid medication shortages in the European Union, the use of electronic system monitoring and prescription (ESMP) will be required as of February 2, 2025, according to Regulation 2022/123.
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) of the European Medicines Agency (EMA) has mandated that, beginning in February 2025, national competent authorities and MAHs will be able to fully submit data on the supply, demand, and availability of centrally and nationally authorized drugs during crises. In order to keep an eye out for and prevent any possible shortages of vital medications, MSSG takes measures like these.
The agency said in a news release that the ESMP's publication marks a significant step in addressing drug shortages and making sure that patients have access to medicines when they need them. The goal is to enhance drug shortage prevention, monitoring, and management throughout the European Union and the European Economic Area (EEA) by centralizing and automating data collecting on medicine shortages. This will provide regulatory agencies with access to comprehensive information in real-time.
The Medicine Shortages Single Point of Contact (SPOC) Working Party webpage of the EMA provides more information regarding drug shortages in the EU. SPOC keeps an eye on developments that can affect the EU's medication supply and reports them. There are shortage registers broken down by EU member state with information on both current and past shortages on the website. Currently, there is a shortage of 30 medications listed by the organization.
Problems with quality control at production plants, strong product demand, and global natural disasters are among the many potential causes of drug shortages. Due to an increase in demand, there is a shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, which was addressed in June 2024 by recommendations given by EMA and the Heads of Medicines Agencies.
A slew of powerful storms pounded the US in late 2024, damaging factories across the country. The North Carolina plant, the biggest US manufacturer of intravenous and peritoneal dialysis treatments, was shuttered by Baxter.
