News

13-01-2026

ESMP update: Expansion in progress | ESMP webpage reorganisation | New ESMP factsheets and updated FAQs

As part of EMA’s ongoing commitment to enhance the European Shortages Monitoring Platform (ESMP) and support its users, the ESMP is expanding with new functionalities, and the development work is progressing. In addition, new and revised support materials are now available on the ESMP webpage, which has been reorganised with some content moved to two dedicated subpages.

ESMP expansion
The ESMP is expanding to include new tools and features that will better support stakeholders in preventing, managing, and mitigating medicine shortages:

• Voluntary solidarity mechanism workflow (for Member States): Implementation of a data submission and management workflow in the ESMP that allows Member States to flag critical national shortages of specific medicines, enabling other Member States to indicate available stock that could potentially be redistributed.
• Critical shortage reporting workflow (for Member States): This feature builds on the current reporting of critical shortages by NCAs to EMA and streamlines the submission and management of critical shortage notifications.
• Vulnerability assessment methodology testing (for the MSSG): In line with the upcoming pharmaceutical legislation reform, this functionality will support the MSSG in testing and automating a new methodology to identify vulnerabilities in the supply chains of medicines. It will allow step-by-step testing and provide initial large-scale analysis using defined indicators.

New ESMP webpage subpages
The ESMP webpage content has been revised and some content reorganised into two dedicated subpages:

• ESMP guidance, training materials and events page - hosting all user and implementation guidance, training materials and information on ESMP events.
• ESMP interoperability page - focused on information on the platform’s interoperability with national and pharmaceutical industry systems.

New and updated resources
To further support stakeholders in fulfilling their reporting obligations new concise factsheets and updated FAQs are available:

• ESMP Factsheets: four one-page summaries of MAHs and NCAs reporting obligations and processes in times of routine shortages, crises, or MSSG-led preparedness actions.
• ESMP FAQs: revised and expanded, with update details available in the revision history table.

18-02-2025

ESMP: full scope of ESMP functionalities live on 29 January

As of 29 January 2025, the European Shortages Monitoring Platform (ESMP) is fully operational . In addition to the routine shortage reporting by marketing authorisation holders (MAHs) of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). These newly released functionalities will be active in ESMP in crises and preparedness situations for affected MAHs of CAPs and non-CAPs according to the list of medicines published for the specific situations.

The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA.

A dedicated training session for all MAHs will be held on 19 February 2025 from 10:00-12:30 CET. Registration is available here (MAH training registration - WebEx) and more information is available on the training event page on EMA's corporate website. The session will be live broadcast and a recording will be published on the event page.

Further, EMA organises a Q&A session for CAP MAHs on the routine CAP shortage reporting functionalities on 25 February 2025, 10:00 - 11:00 CET. Find more information here on the Q&A clinic (event page) and registration is available via this link (Q&A for CAP MAHs - WebEx). The session will be recorded, and the recording will be made available on the event page.

Finally, please note that all relevant and continuously updated ESMP materials can be found on the ESMP webpage on the EMA website.

08-01-2025

ESMP pre-launch for MAHs and available training materials

As of 28 November 2024, the European Shortages Monitoring Platform (ESMP) is officially live for routine shortage reporting by marketing authorisation holders (MAHs).

Marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines (CAPs) to EMA. This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory for CAP shortage reporting to EMA. National reporting requirements remain applicable. The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA.

The full first version of the ESMP will be released by 2 February 2025 and will expand the platform's functionalities to include supply, demand, and availability reporting during crises and MSSG-led preparedness exercises by MAHs and NCAs.

Further information, including training materials, user guidance, and ESMP webinar and ESMP training event recordings, are available on EMA's website to support stakeholders. For more details, visit the ESMP webpage and the press release on EMA's website.