ERA at TOPRA 2025: Session 8 – Human – ePI is on Fire! (I mean FHIR !!)

This session focused on the regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard.

As outlined in the EU pharmaceutical strategy and reinforced by EMA’s digital initiatives, the structured, interoperable ePI format will play a critical role in improving the accessibility, reliability, and lifecycle management of product information.

Regulatory authorities and marketing authorisation holders must prepare for changes in submission formats, review procedures, and data governance models.

The session provided an overview of current status of the EU ePI project including linking to ePI from EU medicine packages, regulatory frameworks, and anticipated timelines.

Practical insights were shared on how regulatory professionals can adapt internal processes and evaluate IT infrastructure needs to ensure compliance and facilitate the seamless integration of FHIR-based ePI into existing regulatory operations.

Points to note:

• Guidance on PLM portal (incl style guide). ePI pilot report available. Reflection paper published Q2-2025. You Tube videos. Quarterly system demos ongoing
• Free software from regulators via PLM portal. Pilot showed it took just 4 hours for a company to create ePI from scratch using these tools
• Technology used is the FHIR common standard for healthcare data exchange. Harmonised EU approach. PLM portal storage and access (FHIR repository)
• User testing would still be required in some form in future
• Better supply chain management for industry 
• 73% of delegates at this session said their company have not implemented any ePI process yet
• ePI will be submitted as additional material alongside word and pdf version for assessment (for a while)
• Once ePI is approved it is put into the central repository and then is available to the patient for download
• Go live for CAPs and early adoption NCA is planned soon (ePI type 1) – likely with New legislation implementation (~2028) – implementing act may have more specific information to clarify ePI requirements
• What does the future look like?: ePI type 4 is under development (ePI 2 & ePI 3 exist but not implemented). ePI type 5 is in the idea stage
• ePI is already implemented in other jurisdictions so EU needs to catch up

Written by

Alice D’Alton