EMA outlines methods for evaluating supply chain vulnerabilities
The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM).On 10 March, EMA published the document that was originally adopted by its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on 17 November 2025. The agency said the methodology is intended to be practical and implementable, while avoiding duplication of existing processes and taking on unnecessary burdens.
"The need to secure the supply of medicines across the EU and avoid shortages has been highlighted as key in the EU Pharmaceutical Strategy for Europe and the new EU pharmaceutical legislation proposal," the document states. "Although the supply of all medicines is closely monitored so that relevant actions can be taken to guarantee their availability, medicines identified as critical for public health will receive particular attention.
"They will be subject to policy measures to improve their security of supply, including recommendations provided for in the revised pharmaceutical legislation and provisions set out in the new Critical Medicines Act," according to the document.
Two phases of the methodology are used to monitor potential supply chain vulnerabilities. The first phase outlines a structured method to monitor macro-level signals that may indicate vulnerabilities. The second phase uses insights from the first phase to examine, in greater depth, potential product-specific vulnerabilities, primarily those from Marketing Authorisation Holders (MAHs).
EMA said Phase 1 will rely on data from readily available sources such as substance, product, organisation and referential (SPOR) master data, in particular Product Management Services (PMS) and Organisation Management Service (OMS) data, and commercial sales data (IQVIA). The agency said it may also be necessary to use supplementary data from MAHs and member states.
If safety signals are detected in Phase 1, the agency plans to review data, including Shortage Prevention Plans from MAHs. In Phase 2, regulators intend to use the European Medicines Regulatory Network to review data available to EMA and the member states. More specifically, they plan to examine data from multiple sources, including Phase 1 outcomes, the manufacturer's market share, the manufacturer's risk analysis of supply chain vulnerabilities, the MAH's strategies for detecting and notifying of supply chain disruptions, and others.
In the next step of Phase 2, the critical medicine is classified into three non-mutually exclusive categories listed as resilient, conditionally vulnerable, and structurally vulnerable. While resilient medicines are considered to have no identified vulnerabilities and sufficient supply chain redundancies and flexibility, the other categories offer a detailed view of the potential vulnerabilities of the drugs, considering how long a shortage may affect the market, the strength of mitigation strategies, and the potential for finding alternative solutions.
Supply chain vulnerability methodology document
