ePI - Successful Pilot Paves the Way for ePI implementation: Read the Final Report
The ePI Pilot Report is now available, marking a significant step toward harmonised electronic Product Information in Europe. Highlighting key recommendations and progress, the report builds on the successful publication of 23 ePIs under the EU ePI Common Standard as part of the ePI pilot. The ePI aims to advance digital access to accurate medicines information.
date: [27/01/2025]
The much-anticipated ePI Pilot Report makes recommendations and outlines the critical development efforts required to integrate electronic Product Information (ePI) into EU regulatory procedures. Its publication marks a significant milestone in EMA’s mission to deliver harmonised ePI, ensuring timely and accurate electronic medicines information for patients and healthcare professionals across Europe.
Funded by EU4Health, the ePI pilot was carried out over the past year by the EMA in collaboration with national authorities from the Netherlands, Spain, Denmark, and Sweden. Together, they successfully published 23 ePIs derived from actual regulatory processes. These ePIs, as all ePIs, comply with the EU ePI Common Standard. This standard enables harmonisation of ePI across the EU. The published ePIs are accessible via the Product Lifecycle Management (PLM) Portal or through a public machine-to-machine Application Programming Interface (API).
The report offers insights into key performance indicators and provides recommendations to enhance guidance, business processes, and the PLM Portal.
Regular updates on further ePI development work are shared in quarterly system demonstrations to keep stakeholders informed.
The successful conclusion of the ePI pilot and the publication of the ePI pilot report demonstrate a continued strong commitment to advancing ePI implementation. The ePI team will continue work on deployment and on building on existing tools and guidance, integrating the report's valuable recommendations.