EMA spells out data access policy for shortage monitoring platform

On Monday, the European Medicines Agency (EMA) issued a new data access policy, elaborating on the differing levels of data access available to different stakeholders via the European Shortages Monitoring Platform (ESMP).

Under this categorization scheme, stakeholders, including the general public, patients and consumers, and academia, will have Level 1 access; marketing authorization holders and their contractors and vendors will have Level 2 access; National Competent Authorities (NCAs) will have Level 3 access; and EMA and the European Commissioner will have the highest-level access to potentially sensitive information.

EMA said the policy establishes “controlled public access to relevant drug shortage information through a tiered access framework. This framework “reflects varying stakeholder needs and data sensitivity levels.”

Regulation (EU) 2022/123 of the European Parliament and Council, dated 25 January 2022, requires marketing authorization holders (MAHs) to implement shortage prevention and mitigation plans for critical medicines, and called for the establishment of the ESMP. The ESMP became fully operational on 29 January 2025.

The policy includes the following principles: mandatory access for regulatory bodies as outlined in Article 13(6)(f) of the Regulation, a publicly accessible webpage that provides information on current shortages of medicinal products, in accordance with Article 6(6) of the Regulation; protection of commercially confidential information, and compliance with data protection regulations.

The policy has four level of access for ESMP:

Level 1 is for the general public which includes patients, consumers, healthcare professionals and academia. These groups will have access to shortages of medicinal products included in the critical medicines lists. EMA states that “this level of access ensures transparency and keeps the public informed about medicine availability and related trends without compromising commercially confidential information or personal data.”

Level 2 is for MAHs, who will have full access to public (Level 1) and restricted subsets of information reported in ESMP. Data in this category include data related to medicine availability, stocks, supply forecasts, and marketing status for nationally authorized products (NAPs); and details on manufacturing capacities and plans for centrally and nationally authorized products during crisis.

Level 3 is for NCAs, who will have full access to public (Level 1) and restricted subsets of information reported in ESMP. The policy specifies that “NCA users are entitled to access all the relevant data submitted by MAHs to support national and EU-level actions in response to potential or actual shortages of centrally authorised products (CAPs) and nationally authorised products (NAPs) of their country. This includes data needed for shortage prevention, mitigation, and management activities. Furthermore, each NCA user can access metadata information on data submissions executed by users of the NCA for which they have an affiliation.”

Level 4, the highest access category, is reserved for EMA, the European Commission, and the Medicine Shortages Steering Group (MSSG). These parties have “full access to both public subset and restricted subset of all shortages of human medicinal product data elements without restrictions.”

Along with its data access policy, EMA also released a compendium of other materials related to the ESMP.

This includes an updated question and answer guide on the ESMP; an updated implementation guide for Competent Authorities, an updated Annex A on the data elements accessible for ESMP access level, an updated implementation guide for marketing authorization holders, and an updated user guide for MAHs.

ESP data access policy

EMA spells out data access policy for shortage monitoring platform

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