Successful pilot paves the way for implementation of ePI
Report outlines recommendations and next steps
NewsHumanProduct information
The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot found that the EU regulatory system is generally prepared for the introduction of ePI and can move towards its phased implementation in regulatory procedures, while first recognising the need for more development, including additional functionalities and integration with current IT systems.
Work on this additional development will be carried out in 2025. After this, the report recommends a phased approach to implementation beginning with voluntary adoption for centrally authorised products, and progressively expanding to nationally authorised products based on Member States’ readiness and available resources.
The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators, with a printed package leaflet also provided in the medicine’s box.
The introduction of product information in an electronic format (ePI) compatible with digital platforms opens new possibilities for patients and healthcare professionals to access and interact with vital, up-to-date information about their medicines.
The report looked at key indicators such as time taken to create ePI, the percentage of ePIs successfully created and published, usability of the IT tools and usefulness of guidance materials. This helped identify recommendations on future work required to enable the introduction of ePI into current regulatory processes. The recommendations call for enhanced guidance to support users, as well as updates to business processes to integrate ePI alongside existing practices with minimal disruption.
The ePI project is being developed by EMA and the Heads of Medicines Agencies (HMA), supported by the EU funding programme EU4Health. The pilot, which involved EMA and the national authorities of Denmark (DKMA), Netherlands (MEB), Spain (AEMPS), and Sweden (MPA), together with industry, resulted in the publication of 23 ePIs from real regulatory procedures, of both centrally and nationally authorised medicines.
ePIs were created following the EU ePI Common Standard, which provides a harmonised structure throughout all Member States ensuring the information works across different e-health platforms for citizens in the EU. The ePIs can be viewed at the Product Lifecycle Management (PLM) Portal and accessed via a public application programming interface.