Navigating the Digital Future: The EMA’s Strategic Roadmap for Electronic Product Information (ePI)
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24 Mar Navigating the Digital Future: The EMA’s Strategic Roadmap for Electronic Product Information (ePI)

Posted at 19:55h in Regulatory Affairs by

The digital transformation of the European pharmaceutical regulatory landscape is accelerating. For healthcare professionals, the slow transition from paper-based leaflets to a structured digital format is one of the significant shifts in how we manage and communicate medicine information. In March 2026, the European Medicines Agency (EMA) published a new draft roadmap for Electronic Product Information (ePI), signalling the next moves forward.

What is ePI and How Did We Get Here?

ePI refers to the authorised, statutory product information for a medicine (i.e., the Summary of Product Characteristics, Package Leaflet and Labelling) in a semi-structured format. Unlike a simple PDF, ePI uses the HL7 FHIR (Fast Healthcare Interoperability Resources) international standard. This technical structure allows the information to be easily shared across different platforms and viewed on various devices, such as smartphones or electronic health records.

The strategic roots of this initiative date back to 2017. Following a European Commission report, the EMA published an Action Plan that prioritized the development of electronic SmPC/PL formats. This early commitment led to the publication of the “Key Principles” for ePI in 2020. More recently, a successful pilot project (July 2023–August 2024) tested the real-world creation of ePIs, setting the stage for the full-scale transition we are seeing today.

Why ePI Matters

The transition to ePI is not merely a technical upgrade; it is a fundamental improvement in public health delivery. The EMA identifies several key benefits in its “Key Principles” document:

  • Timeliness and Safety: Traditional paper leaflets are subject to printing and distribution lags. ePI enables the immediate dissemination of updated safety information and variations, ensuring healthcare professionals and patients always have access to the latest data.
  • Accessibility and Searchability: Digital formats allow for features like adjustable font sizes, text-to-speech, and advanced search functions. This is particularly transformative for patients with visual impairments or those who need to quickly locate specific dosage instructions.
  • Interoperability: Because ePI is based on structured data standards, it can be integrated with other digital health tools, such as electronic prescriptions and digital health records, reducing the risk of medication errors.

 

Some of additional points to consider:

  • Patient Safety and Digital Access: With the majority of EU citizens regularly accessing the internet, ePI allows for interactive elements and personalized content. Importantly, alternatives for those without internet access will be retained to guarantee inclusivity.
  • Safeguarding Availability in Small Markets: Multi-country packs are simplified by the use of ePI and language exemptions, improving medicine availability across Europe—particularly in smaller markets—by reducing logistical burdens.
  • Regulatory Efficiency: The ePI platform streamlines processes and reduces administrative burdens. A centralized EMA portal will serve as a single source of trustworthy, regulator-approved information.

 

A Closer Look at the New ePI Roadmap

The newly released draft roadmap provides a vision for the full-scale implementation of ePI across the European medicines regulatory network. The document outlines a phased approach to move from the current pilot phase to a “business-as-usual” state where ePI is the standard for all human medicines.

The roadmap focuses on three strategic pillars:

  • Technical Readiness: Enhancing the ePI authoring tool and ensuring it integrates seamlessly with the Iris platform and other EMA digital services.
  • Implementation and Expansion: A phased “go-live” for Centrally Authorised Products (CAPs) is expected from Q4 2026, starting with vaccines and oncology, before expanding to other therapeutic areas.
  • Network Integration: Ensuring that National Competent Authorities (NCAs) have the infrastructure to support ePI, allowing for a harmonized digital experience across both CAPs and NAPs.

 

Conclusion

For pharmaceutical companies and regulatory consultancies, the message is clear: the digital leaflet is no longer a “future concept”. Staying aligned with the timelines and technical standards outlined in this new roadmap will be essential for maintaining compliance and ensuring that medicines remain accessible and safe for patients in the digital age.