European Shortages Monitoring Platform

The European Medicines Agency (EMA) is setting up the European Shortages Monitoring Platform (ESMP) to gather information about medicine supply and demand in order to prevent, detect, and manage human medicine shortages in the European Union (EU) and European Economic Area (EEA).

EMA will collect data via the platform from the national competent authorities (NCAs) and marketing authorisation holders (MAH).

EMA is setting up the platform as part of its extended mandate, in line with Regulation (EU) 2022/123. For more information, see Crisis preparedness and management. 

The first version of the platform will be available by February 2025.

Role of platform

The European Shortages Monitoring Platform will enable EMA to monitor the supply, demand and availability of critical medicines needed during crisis situations, which can be public health emergencies or major events. 

EMA publishes the list of critical medicines it monitors for each crisis situation. For more information, see Availability of critical medicines.

Outside crises, EMA will use the platform in two ways: 

• to monitor supply and availability of medicines when asked by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products;
• for preparedness activities to prevent and manage shortages which might lead to a public health emergency or major event, including enabling marketing authorisation holders to routinely report shortages of centrally authorised products.

For more information on EMA's role in addressing medicine shortages, see:

• Crisis preparedness and management

Development and milestones of platform

EMA is developing the platform in line with the Scaled Agile Framework (SAFe).

Following an Agile approach means that the platform will start with basic features and EMA will gradually add more over time.

EMA will keep stakeholders up-to-date on the platform's development with informative sessions, technical guidance and public demonstrations.

For more information on SAFe at EMA, see: 

• Network Portfolio: Agile transformation

The timeline bellow highlights the key ESMP-related developments and milestones, from the adoption of legislation requiring the platform to the availability of the first version of the platform. 

Development and milestones timeline

1. Adoption of Regulation (EU) 2022/123

   First quarter of 2022

2. Registration of industry single point of contact (i-SPOC) for medicine supply and availability

   Third quarter of 2022

   For more information on iSPOCs, see Industry contact points for supply and availability of critical medicines.

3. IT developments and enhancements

   From fourth quarter of 2022 to the first quarter of 2025

4. Development of functionalities for marketing authorisation holders (MAH)

   From fourth quarter of 2022 to the first quarter of 2025

5. Development of functionalities for national competent authorities (NCA)

   From first quarter of 2024 to the first quarter of 2025

6. Interoperability with NCA and MAH systems

   From first quarter of 2024 to at least the first quarter of 2025

   From implementation plan agreement to deployment

7. Launch of first version of the platform ( the 'minimum viable product')

   First quarter of 2025
8. Show more 4 itemsHide 4 items

Quarterly public system demonstrations

EMA carries out public system demonstrations - or demos - to inform and involve stakeholders in the development of the European Shortages Monitoring Platform (ESMP).

Information on these demos is available in the table below. Demo video recordings are available by visiting the event pages linked in the table.

Demo event	Functionalities showcased	Video recording timestamp
Quarterly system demo - Q1 2024 (26/03/2024)	User interface design MAH routine reporting of shortages of centrally authorised products Portal for EMA case management of shortages Public health emergency monitoring dashboards for member states	03:01:45
Quarterly system demo - Q3 2023 (21/09/2023)	Template download for marketing authorisation (MAH) holder bulk submission of shortages Submission of alternative substances Embedding marketing status for centrally authorised products Data analytics platform	00:26:24
Quarterly system demo - Q1 2023 (22/03/2023)	Data elements and upload for MAH bulk submission of shortage information	2:17:20
Quarterly system demo - Q3 2022 (28/09/2022)	MAH submission of individual shortages	1:08:53

Described functionalities may change over time as the development process is gradual and iterative. 

For information on other events featuring the ESMP, please search via keywords ('ESMP' or the 'European shortages monitoring platform') in the events section on EMA's corporate website:

• Events

Interoperability with national and pharmaceutical industry systems

EMA is working to make the platform interoperable with national and pharmaceutical industry systems so that data can be easily exchanged between these systems.

This will help harmonise and simplify monitoring and reporting on medicine shortages in the EU.

While interoperability can reduce the need for user action, users will still be able to manually submit data through the ESMP interface.

An implementation timeline is available below. 

Implementation timeline

1. Definition of technical formats and implementation plan

   First quarter of 2024

2. Detailing of data fields and formats, creation of guidance materials

   Second and third quarter of 2024

3. Start of machine-to-machine solution implementation

   Fourth quarter of 2024

4. First data set available in machine-to-machine solution

   First quarter of 2025

5. All data sets available in machine-to-machine solution, in line with prioritisation

   Between second and fourth quarter of 2025
6. Show more 2 itemsHide 2 items

Contact

For more information and related questions, you can contact EMA through our AskEMA portal:

• Send a question to the European Medicines Agency