16 December 2024 – The European Medicines Agency (EMA) has reported that the pilot project for creating and testing electronic product information (ePI) in real regulatory procedures has shown that the regulatory system of the European Union (EU) is generally prepared for the introduction of ePI. The introduction can proceed in phases, although further development is required initially, particularly in terms of additional functionalities and integration with existing IT systems. This further development is planned for 2025.

The report recommends a phased approach to implementation, starting with voluntary adoption for centrally authorized products, followed by gradual expansion to nationally authorized products, depending on the readiness of Member States and available resources. The ePI project is being developed by the EMA and the Heads of Medicines Agencies (HMA), supported by the EU funding program EU4Health.

The ePIs created during the pilot have been developed according to the EU ePI Common Standard, ensuring a harmonized structure across all Member States and enabling use across different e-health platforms.

For more information, see here.