Module 12 Presentations

EMA Portfolio Value Stream roadmap

Highlights from Strategic Review Meeting (Q3-2023)

Product Lifecycle Management

Electronic Product Information (ePI):

➢ The ePIis authorised, statutory product information for medicines (i.e., SmPC, PL, and labelling) in a semi-structured format created using the EU ePI Common Standard (HL7 FHIR). ➢ ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print ➢ The minimum viable product for EMA for ePI ➢ An ePI authoring portal ➢ Rich text editing – supporting creating and editing the ePI ➢ Repository and API – storage of ePI on a FHIR server and made available through API ➢ Current state: pilot rolled out with MVP across all procedure types with agency and industry participants ➢ Continues until H2 2024 ➢ No concrete timelines on connecting ePI portal with PMS product records

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12