A new step forward towards the implementation of electronic product information (ePI) was made with the publication in December 2024 of the ePI pilot report on the experience gained from the creation of ePI during regulatory procedures for EU human medicines.
The pilot was run from July 2023 to August 2024 by EMA together with the NCAs of Spain (AEMPS), Denmark (DKMA), the Netherlands (MEB) and Sweden (MPA), envisaging the ePI’s creation and publication in live regulatory procedures.
According to the results, the EU regulatory system proved to be generally prepared for the introduction of ePI. A phased implementation in regulatory procedure could thus be planned, even if additional functionalities and integration with current IT systems would be needed. According to EMA, this task will be carried out in 2025.
The phased approach to implementation should begin with voluntary adoption for centrally authorised products, to then progressively expand to nationally authorised products based on Member States’ readiness and available resources.
Source: EMA