After the end of the transition period, the use of the European Shortages Monitoring Platform (ESMP) to report issues in the supply of medicinal products will become mandatory on 2 February 2025 (link to the dedicated webpage).
The European Medicines Agency launched the first version of platform at the end of November 2024, based on a still limited set of functionalities. The end of the transition phase will also correspond to the availability of the second version of the platform, to be used by marketing authorisation holders (MAHs) to routinely report shortages of centrally authorised medicines. The new release will be characterised by full functionalities for both MAHs and national competent authorities (NCAs).
Information on ongoing shortages and resolved ones for human medicines can be found in the EMA shortages catalogue, available on the dedicated page of EMA’s website, as also links to the single national registers of shortages for both human and veterinary medicines.
The main features of the ESMP platform
The main target of the ESMP platform is to centralise and automate data collection on medicine shortages, so as to provide regulatory authorities with real-time access to comprehensive information on supply issues experienced in the EU and European Economic Area (EEA).
Detailed guidance on the management of potential or actual shortages from the different perspectives of MAHs, regulators, patients and healthcare professionals is also available.
EMA also released specific ESMP implementation guidance for MAHs and NCAs. We resume the main features of the platform as well as other elements of the EU system to prevent shortages.
Access of MAHs to the ESMP platform requires previous registration to the Industry Single Point of Contact (i-SPOC) system. Required data may be submitted in tabular format (through the excel templates) or through machine-to-machine submission supported by interoperable MAHs and NCAs systems.
The ESMP platform is integrated with other EMA’s data management systems, i.e the Account Management Portal (EAM), the Substance, Product, Organisation, Referentials (SPOR) regulatory data management system from which to retrieve harmonised data on, for example, referentials master data, or the Interactive Regulatory Information System (IRIS), providing data on the marketing status of centrally authorised products.
Under normal circumstances, MAHs’ routine reporting will include the submission of history and associated metadata for individual entries. The information required also refers to prevention and mitigation plans and shortage impact assessment, and to the indication of the available alternative therapies. On this basis, EMA will be able to evaluate and manage the reported shortage cases in an integrated and highly automated manner.
The second version of the ESMP will also include functionalities specifically targeted to both the preparedness and crisis phases, extending the reporting to other types of information, i.e. availability, marketing status, market share, sales volume and forecast, manufacturing information, stock and supply, patient estimation, national demand, alternative therapies and medicine usage.
More specifically, in the case of preparedness exercises to be launched by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), the ESMP will support the monitoring of the supply and demand of medicinal products included in a specific list drafted by the MSSG itself.
Similarly, another specific list of critical medicines may be established after the declaration of a public health emergency or another major event by the European Commission. In such instance, the list would be focused on immediate actions needed to face the situation. Both lists may contain centrally and nationally authorised medicines, those supplies would be monitored through the ESMP according to a reporting frequency to be defined by the MSSG.
Furthermore, under normal circumstances, the NCAs will submit routine reporting on critical shortages, while under a preparedness exercise the estimated member state demand of medicines included in the list for a six-months period has also to be provided. The declaration of crisis will trigger the submission by NCAs of stock and supply information, estimation of patients and their needs (e.g. vaccines, hospitalisation or intensive care units (ICU) for a six-months period) and medicine usage in terms of average daily dose and estimated proportion of patients that are expected to receive the treatment in hospitals or ICU.
A pilot on shortage prevention and mitigation plans
According to Regulation (EU) 2022/123, EMA’s extended mandate includes the monitoring and mitigation of shortages for both medicines and medical devices, under the coordination of the respective two Executive Steering Groups.
The ESMP platform is just one of the many actions put in place to reduce the occurrence of medicine shortages. A pilot on the implementation of shortage prevention and mitigation plans (SPP and SMP, respectively) was launched by EMA in December 2024, after endorsement by its Medicine Shortage Steering Group (MSSG).
SPPs, while not yet mandatory, are expected to help identify potential risks in the supply chain and corresponding measures to handle them. SMPs refer to plans aimed at mitigating potential or actual shortages. Both plans should be developed by MAHs, using the templates and guidance available on the dedicated webpage.
EMA’s pilot aims at harmonising the implementation of SPPs and SMPs by MAHs and national competent authorities, and to collect information on the use made by MAHs of the provided templates. Only four active ingredients were selected by EMA’s Medicine Shortages SPOC Working Party to be part of the pilot (alteplase, amoxicillin, amoxicillin with clavulanic acid and verteporfin). Further APIs might be added in future, should reports emerge on potential or ongoing critical shortages.
Improved attention to critical medicines
Another important step towards a better identification and management of shortages is represented by the creation of the Union List of Critical Medicines (link to the dedicated webpage). The second version of the list was published on 16 December 2024. The List contains both innovative and generic human medicines identified as critical for the health of European citizens and thus prioritised for minimisation of the risk of supply disruptions.
The selection of medicines to be included in the Union list is based on a specific methodology based on two main criteria, the seriousness of the disease and the availability of other treatments. The Union list was created based on the review by NCAs of 2,200 active substances groups and combinations, corresponding to 75% of the medicinal products authorised in the EU. A key element to manage supply issues for critical medicines is represented by the Critical Medicines Alliance, launched in January 2024 and grouping representatives of the pharmaceutical industry, civil society and academics.
The main objective of this consultative platform is to provide support to the EU Commission and other decision-makers at the European level in identifying vulnerabilities in the supply chains of critical medicines and how to address them. The Alliance is also called to support the EU’s industrial competitiveness and open strategic autonomy.
In this instance, two Working Groups have been created, respectively addressing the strengthening of EU manufacturing capacities for critical medicines and their active pharmaceutical ingredients and the diversification of international partnerships and cooperation.
