European Shortages Monitoring Platform (ESMP)

In June 2024 the EMA announced that they were setting up a new European Shortages Monitoring Platform (ESMP) and on 31 July they published more detail on the role of this platform and how it will work.? The first version of the ESMP is expected to be available from February 2025.

The ESMP will enable EMA to monitor the supply, demand and availability of critical medicines in three distinct phases:

·???????? crisis situations, which can be public health emergencies or major events,

·???????? when requested by EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), also known as MSSG-led preparedness,

·???????? normal circumstances.

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

1.?????? MSSG-led preparedness for a sub-set of both centrally and nationally authorised medicines included in a list created for that particular activity,

2.?????? 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.

As of February 2025, all EU marketing authorisation holders (MAHs) will be obliged to use the platform to report data on supply and availability of medicines in the above listed cases.

EMA encourages MAHs to start submitting data on shortages of centrally authorised medicines during a transition period, which runs from November 2024 to February 2025.