The European Medicines Agency's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) adopted an updated Shortage Prevention Plan (SPP) template and guidance for industry during its meeting on 17 July 2026, incorporating feedback from industry associations gathered through a written consultation and a dedicated workshop. The adoption came as the group received updates on the final stages of the new pharmaceutical legislation and the Critical Medicines Act, which will reshape how the EU manages medicine shortages and supply chain vulnerabilities.
The meeting, chaired by EMA Executive Director Emer Cooke and Karl Broich of the Heads of Medicines Agencies, heard from DG SANTE that the lawyer-linguist review of the new pharmaceutical legislation has been completed, with publication expected in December 2026. Most provisions are slated to apply 24 months after publication, but shortage prevention plans will apply after six months, and provisions on the Union list of critical medicines and vulnerability assessment will apply immediately. The Commission also briefed the MSSG on the provisional political agreement on the Critical Medicines Act reached under the Cypriot Presidency, highlighting tasks related to contingency stocks, a voluntary solidarity mechanism, and MSSG recommendations on collaborative procurement and stock allocation. DG SANTE noted that the Agency's obligation to establish a digital overview of contingency stock requirements could be met using a spreadsheet format such as Excel.
EMA also updated the group on the ongoing 2026 Vulnerability Assessment exercise, reporting that 197 marketing authorisation holders had been contacted. Follow-up will target companies with significant market share that have not yet responded, with the European Commission offering support. Members discussed challenges related to insufficient or poor-quality data, including cases where high-market-share companies had not provided information. It was agreed that the exercise would continue using the data gathered, with the Working Group presenting outcomes to the MSSG in December, including clear justification and descriptions of challenges. The group also discussed the need to understand why companies struggle to provide data and to simplify requirements over time while maintaining necessary information levels.
The adopted SPP template and guidance, revised to align with the new pharmaceutical legislation, will help industry prepare for implementation. The Commission noted that companies may use the period before the provisions apply to prepare. The updated template and guidance are expected to impose new compliance requirements on pharmaceutical companies, which will need to adapt their shortage prevention planning to the new standards. For national authorities, the template provides a standardised framework for assessing and mitigating shortages, potentially improving coordination across Member States. Patients stand to benefit from more robust shortage prevention, reducing the risk of medicine unavailability. However, the administrative burden on smaller companies may increase, as they must align with the new template and data requirements, even as the exercise aims to simplify data collection over time. The MSSG's next steps include finalising the vulnerability assessment outcomes for December and preparing for the implementation of the new legislation and the Critical Medicines Act.