EMA更新ESMP实施指南与用户指南，新增关键药品短缺报告章节

The European Medicines Agency (EMA) has updated its Implementation Guide and User Guide for the European Shortages Monitoring Platform (ESMP), which are intended for national competent authorities. Both documents now contain a dedicated chapter on reporting critical medicine shortages, providing further detail for authorities submitting relevant information to the EMA through the platform. The ESMP is a digital platform for exchanging information on medicine availability, supply and demand. National competent authorities and marketing authorisation holders can use it to provide data on centrally authorised medicines and, under certain conditions, nationally authorised products. The information is intended to help identify potential shortages at an early stage, assess how they may develop and support appropriate responses. Two guides with different focusesThe Implementation Guide, updated on 29 September 2026, has been expanded to include Chapter 4.1 on “Critical Shortage Reporting.” It focuses primarily on the technical requirements for submissions, describing the datasets and data elements relevant to reporting to the EMA. For each data element, the guide provides details such as its identifier, name, description, examples, data type and validation rules. It also specifies conformity requirements and references to the relevant target system. A revision history allows users to track changes from previous editions. The first version of the Implementation Guide was published in July 2024. The User Guide, last updated on 26 September 2026, complements the technical specifications with practical procedural guidance. Its new Chapter 5.1 explains how national authorities should transmit data electronically through the ESMP. It also provides information on the procedures to be followed and the associated technical requirements. Information covered by the guidanceThe updated guides are intended to help authorities submit structured information on different aspects of medicine supply, including: stock levels and the current supply situation estimates of the number of patients affected medicine consumption national demand for medicines other crisis-related information and preparedness data The guides support national authorities in meeting their reporting obligations relating to crisis response and preparedness. The applicable requirements are set out in Regulation (EU) 2022/123, particularly Article 11. Both updated documents are available on the EMA website: Implementation Guide for national competent authorities and User Guide for national competent authorities.