FHIR® ePI 101: a beginner’s guide to electronic labeling
Regulatory authorities worldwide are moving toward electronic product information (ePI) built on FHIR®. For Regulatory Affairs, Labeling, and Artwork teams, this shift changes how product information is created, structured, submitted, and updated.
But with new acronyms, XML formats, and evolving regional requirements, it’s not always clear where to start.
FHIR ePI 101 is a clear, visual glossary that explains the fundamentals of structured electronic labeling, without the technical overload.
What you’ll learn in this guide
- What e-labeling, ePI, and FHIR actually mean — and how they connect
- The difference between structured XML labeling and unstructured PDFs
- Why regulators are piloting FHIR-based ePI frameworks
- How structured labeling improves searchability, interoperability, and version control
- What this shift means for pharma labeling workflows in 2026 and beyond
Why this matters now
The move to FHIR-based ePI isn’t theoretical. It’s already influencing regulatory pilots, interoperability standards, and digital submission requirements. Teams that understand structured labeling today will be better prepared for global alignment tomorrow.
