EMA Overview: European Shortages Monitoring Platform (ESMP): How the EU Monitors, Prevents, and Manages Medicine Shortages

Sharan Murugan
5 hours ago
3 min read

Medicine shortages can have a direct and serious impact on patient care, healthcare systems, and public health across Europe. To strengthen coordination, improve visibility, and enable early action, the European Medicines Agency (EMA) has established the European Shortages Monitoring Platform (ESMP). The ESMP is a central digital platform designed to support the prevention, identification, monitoring, and management of shortages of medicinal products across the EU and EEA.

Key Definitions Used in ESMP

A shortage is defined as a situation where the supply of a medicinal product authorised and placed on the market in a Member State does not meet national demand, regardless of the cause.
An actual shortage occurs when the supply can no longer meet demand.
A potential shortage refers to a situation that may lead to a shortage and must be reported as soon as the marketing authorisation holder (MAH) becomes aware of it.
A crisis refers to a public health emergency or major event affecting the EU medicines supply chain.An MSSG-led preparedness action is a proactive monitoring activity triggered by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to prevent a potential crisis.

Why the ESMP Was Created

The ESMP was established to support a shared European vision: ensuring the availability of medicines for patients across the EU/EEA. The platform enables structured information exchange between the EMA, national competent authorities (NCAs), and industry stakeholders, allowing shortages to be identified early and managed more effectively.

What the ESMP Does

The ESMP enables centralised reporting and monitoring of medicine supply and availability. It supports:

routine reporting of shortages,
enhanced monitoring during preparedness actions, and
intensive data collection during crises.

For MAHs, the platform captures information such as shortage status, root cause, expected timelines, manufacturing constraints, and mitigation measures. For NCAs, it aggregates national supply and demand data, enabling EMA to assess risks across the EU.

The ESMP operates under three distinct scenarios, each with different reporting requirements.

Normal circumstances
In routine situations, MAHs must report all potential and actual shortages of centrally authorised products (CAPs) via the ESMP, regardless of duration.
MSSG-led preparedness
When triggered by the MSSG, a defined subset of medicines must be closely monitored. Both MAHs and NCAs submit additional supply, demand, and availability data for the products in scope, based on a specific list published for the preparedness action.
Crisis situations
During a public health emergency or major event, EMA activates crisis monitoring for a list of critical medicines, which may include both CAPs and nationally authorised products (non-CAPs). Reporting frequency and scope are defined by the MSSG, and data are used to support EU-level crisis management.

Access, Roles, and Governance

Access to the ESMP requires an EMA account and approved user roles. MAHs must appoint an industry single point of contact (i-SPOC), but ESMP reporting can be performed by other authorised users within the organisation. Clear internal coordination is essential to ensure consistent and timely reporting.

By centralising reporting, enhancing transparency, and supporting crisis preparedness, the ESMP strengthens Europe’s ability to protect patients and healthcare systems from supply disruptions.

For MAHs and regulators alike, understanding ESMP requirements and integrating them into routine operations is now an essential part of medicines lifecycle and supply-chain management.

This blog is based exclusively on the following EMA documents: