The recently published ePI roadmap outlines the proposed approach and key milestones for the implementation of ePI across the EU regulatory network.Date: [10/04/2026]
The draft ePI roadmap has been published on the EMA website, outlining the proposed approach and key milestones supporting the implementation of ePI across the EU regulatory network.
The draft roadmap describes the planned phased transition towards ePI for human medicines and reflects collaboration between EMA, the Heads of Medicines Agencies (HMA), and the European Commission (EC) to enable harmonised creation, management, and dissemination of product information in electronic format. The roadmap will ensure timely and coordinated delivery of ePI in line with upcoming legal requirements under the new pharmaceutical legislation.
The implementation of ePI aims to improve accessibility, searchability, and interoperability of product information, supporting delivery of up-to-date information to patients and healthcare professionals, more efficient regulatory processes and future integration with digital health systems.
The roadmap will continue to evolve as further experience is gained through ongoing activities and engagement with stakeholders across the EU medicines regulatory network.