European Shortages Monitoring Platform (ESMP): Interoperability with national and pharmaceutical industry systems

The European Shortages Monitoring Platform (ESMP) enables easy and consistent data sharing across the systems of national competent authorities (NCAs) and marketing authorisation holders (MAHs) for monitoring and reporting medicine shortages in the European Union (EU).

EMA designed the platform with interoperability as a core principle, in line with the European Commission's Interoperability Framework.

The platform's interoperability with the systems from national competent authorities (NCAs) and marketing authorisation holders (MAHs) ensures that data can be easily exchanged between these systems.

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

The platform also uses structured data and controlled terms from Substance, product, organisation and referential (SPOR) master data to ensure consistent reporting and convergence between systems.

For NCAs and MAHs who already store their data within their internal systems, the platform enables data extraction and direct upload into it. They can still manually submit data through the ESMP interface.

To find EMA's interoperability assessment report on ESMP, see:

• EMA interoperability assessment reports

Automation of data submission

EMA developed a machine-to-machine communication interface to further enhance interoperability and streamline data submission from NCAs and MAHs.

EMA has established a set of rules and protocols to define the framework for stakeholders' systems to interact and share data with the platform. This is also known as an application programming interface (API). 

A document describing the API specifications for MAHs and NCAs is available below.

In addition, MAHs and NCAs can find instructions on how to request access to the API, alongside supporting documents on the API specifications, and field and business rules for the datasets.

European shortages monitoring platform (ESMP) API - Instructions to request access for national competent authorities (NCAs) and marketing authorisation holders (MAHs)

European Shortages Monitoring Platform (ESMP) Application Programming Interface (API) specifications

Fields and business rules for the European Shortages Monitoring Platform (ESMP) API datasets

European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for marketing authorisation holders (MAHs) (JSON) (YAML)

European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML)

Implementation timeline for the API

An implementation timeline is available below for the API.

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 sets available in machine-to-machine solution

   Routine shortage reporting for MAHs, MSSG-led preparedness reporting for NCAs

   First quarter of 2025

5. Show more 1 itemsHide 1 items