FHIR-based ePI: A practical playbook for regulatory and labeling teams

Everything you need to know about the shift to structured e-labeling, definitions, insights, and practical next steps.

Regulators including the EMA, FDA, and MHRA are moving toward electronic Product Information (ePI) built on the FHIR standard. For regulatory and labeling teams, that marks a real shift in how content is created, reviewed, submitted, and maintained over time.

FHIR-based ePI introduces structured, XML-driven content with new expectations around accuracy, consistency, and control. That raises practical questions:

• How will daily workflows change?
• What happens to existing review and submission processes?
• And what can teams do now to prepare, without adding risk or rework?

This playbook brings those answers together in one place. It combines expert insight, real-world feedback from regulatory professionals, and clear guidance to help life sciences teams understand what’s changing and how to respond with confidence.

Inside the ebook, you’ll learn:

• Clear definitions of e-labeling, ePI, and FHIR and how they fit together
• Poll results from 90+ RAPS regulatory professionals 
• The five essential capabilities a proofreading solution needs to support FHIR XML
• A global snapshot of where FHIR-based ePI adoption stands today
• A practical checklist to help you start preparing for e-labeling now

Bonus resource:

• Access to an on-demand webinar featuring real-world use cases and lessons learned.

Download the playbook

Download your copy and take the first step toward future-ready labeling.