For decades, the way medicines communicate safety and usage information has remained largely unchanged. Prescribing information, package leaflets, and labeling have traditionally been created and distributed as static documents, often in PDF format.
That approach is beginning to evolve. Electronic product information (ePI) is changing how regulatory content is created, managed, and shared by moving product information from fixed documents into structured, machine-readable data.
Built on the HL7 FHIR standard and supported by established approaches such as structured product labeling (SPL), ePI is designed to improve how regulatory information is maintained, accessed, and exchanged across healthcare systems and global markets.
This article explores how ePI works, the benefits it provides, implementation challenges, validation considerations, and what regulators are indicating about the future of regulatory content management.
What Electronic Product Information Means
A medicine’s product information is regulated, scientifically reviewed content that supports safe prescribing, dispensing, and patient use. According to the European Medicines Agency (EMA), electronic product information refers to authorized statutory product information, including the summary of product characteristics, package leaflet, and labeling, adapted for electronic management and distribution through digital platforms, websites, and printed formats.
In the United States, the FDA has used structured product labeling (SPL) as a standard method for exchanging product and facility information. SPL, developed using Health Level Seven (HL7) document markup standards, established the foundation for structured regulatory content.
The broader ePI approach expands on this model by moving beyond document-based labeling toward structured information that can be searched, processed, and reused across systems, regions, and languages.
How HL7 FHIR Transforms Regulatory Information Management
The technology supporting modern ePI is HL7 FHIR (Fast Healthcare Interoperability Resources). Unlike traditional documents that store information as a single formatted file, FHIR organizes data into structured resources that can be processed by both people and digital systems.
The EMA has adopted FHIR as the foundation of its European Union ePI Common Standard. This implementation guide defines how FHIR resources can be used to generate consistent product information across the European Union.
The FDA has also explored the use of SPL-on-FHIR, recognizing that HL7 no longer promotes the older Version 3 standards on which SPL was originally based. This transition reflects a broader movement toward interoperable regulatory information systems.
By using structured data, FHIR-based ePI can support connections with electronic health records and e-prescribing systems. It also improves the ability to update information efficiently, search content more effectively, and manage multilingual product information.
Benefits of ePI Implementation
The transition to ePI provides benefits across regulatory operations, healthcare systems, and patient access. By moving away from static documents and toward structured content, organizations can improve how regulatory information is maintained and shared.
Improved Access and Patient Safety
Structured, machine-readable information can be integrated directly into healthcare systems, allowing healthcare professionals and patients to access accurate and current product information when needed.
The EMA has identified improved accessibility, searchability, and multilingual support as key advantages of electronic product information. By making regulatory content easier to find and update, ePI can support more informed healthcare decisions and improve the overall management of medicine information.
Greater Efficiency for Regulatory Systems
Because ePI content is structured and reusable, updates can be managed more efficiently than with traditional document-based approaches. Changes to product information can be implemented and distributed more consistently, reducing manual effort and limiting duplication across markets.
This approach also supports greater consistency when managing regulatory content across multiple regions and submissions.
Interoperability and Integration
FHIR-based ePI supports integration with existing regulatory systems, databases, and standardized terminology resources. Rather than creating separate versions of the same information for different platforms, organizations can maintain structured content that can be adapted for various regulatory and healthcare environments.
This creates a more efficient approach to managing product information throughout its lifecycle.
Implementation Challenges
While ePI offers significant advantages, implementation requires organizations to address several technical and operational challenges.
One of the largest considerations is international harmonization. Different regions have historically developed their own approaches to regulatory information management, including SPL-based systems in North America and FHIR-based models in the European Union. Aligning these approaches will be important to ensure consistency across global markets.
Organizations must also address the practical challenges of transitioning from traditional documents to structured data. Converting existing Word and PDF files into structured FHIR XML or JSON formats requires new technologies, updated authoring processes, and personnel who understand both regulatory requirements and data structures.
Additional considerations include managing change control, maintaining version history, and supporting multilingual content. Since ePI relies on consistent product identification, alignment with medicinal product identification standards must be established early in the implementation process.
Validation Requirements
Validation remains essential for ensuring that regulatory content is accurate, complete, and reliable. The FDA maintains an SPL Implementation Guide with Validation Procedures that defines requirements for submitted structured labeling content. These standards provide a foundation for ensuring information is properly formatted and meets regulatory expectations.
As ePI adoption increases, regulators are working to ensure that validation approaches continue to support structured content reliability. This includes confirming that information remains complete and accurate when transferred between different formats and systems.
For life sciences organizations, validation must address both the content itself and the systems used to create, manage, and distribute that content. Data integrity, controlled access, version management, and traceability are all important considerations when implementing ePI platforms.
The EMA has also conducted pilot programs and user acceptance testing related to FHIR-based ePI functionality. These efforts demonstrate the importance of thorough testing before structured product information becomes part of routine regulatory workflows.
Future Regulatory Expectations
Regulators are continuing to move toward structured regulatory content as a long-term approach for managing product information. The EMA, in collaboration with the Heads of Medicines Agencies and the European Commission, has published key principles for ePI development and continues to demonstrate progress through public discussions and system demonstrations.
The EMA has also explored approaches for improving patient access to electronic product information, including the potential use of codes on medicine packaging that allow users to quickly access approved product information digitally.
In the United States, the FDA continues to advance structured product labeling initiatives and evaluate how FHIR-based approaches may support existing regulatory information processes.
As these efforts progress, organizations should expect structured product information to become increasingly common within regulatory submissions and lifecycle management activities. Preparing early by improving data governance, adopting structured content practices, and establishing validation processes will help companies transition more effectively as expectations evolve.
Conclusion
Electronic product information represents a significant change in how regulatory content is created, maintained, and shared. By transitioning from static documents to structured, FHIR-based data built on the foundation of structured product labeling, ePI provides a more efficient approach to managing medicine information across systems and markets.
The transition will require organizations to address challenges related to global alignment, technology adoption, and validation. However, regulatory momentum indicates that structured product information will continue to become a larger part of the future regulatory landscape.
Companies that begin strengthening their content management practices, data governance strategies, and validation frameworks now will be better prepared as ePI becomes a more widely adopted standard.
About PSC Biotech®
Founded in 1996, PSC Biotech® has spent three decades helping life sciences organizations ensure their products are developed, manufactured, and distributed in compliance with applicable regulatory requirements.
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References
U.S. Food and Drug Administration. Structured Product Labeling Resources.
https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources
U.S. Food and Drug Administration. Structured Product Labeling (SPL) Implementation Guide with Validation Procedures.
https://www.fda.gov/media/84201/download
European Medicines Agency. Electronic Product Information (ePI).
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi
European Medicines Agency. Electronic Product Information for Human Medicines in the European Union – Key Principles.
https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles