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.
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