ePI and FHIR: Understanding the Paradigm Shift in Regulatory Information Management
Why ePI Is Changing More Than Just Regulatory Outputs - Glemser
Summary
Electronic Product Information (ePI) is not merely a content delivery format, but an issue concerning the creation, structuring, and governance of regulatory information. Organizations are advised to proceed toward FHIR readiness incrementally while maintaining existing processes.
Details
Many organizations currently rely on document-centric workflows for managing regulatory content, which creates inefficiencies and risks when adapting to new output requirements because the content is difficult to reuse or govern. FHIR highlights these challenges, promoting a shift towards treating content as a structured asset. Initially, it is possible to start by converting existing approved documents into FHIR formats (downstream), allowing organizations to gain experience without redesigning upstream workflows. Ultimately, the focus must shift to an 'operating model' where regulatory content itself is treated as structured and reusable. This transition enhances content quality control and the ability to manage changes across different markets. This trend indicates a clear direction: regulatory information is becoming more digital, more structured, and more interconnected. Early investment in improving content management is crucial for organizations not just for compliance, but also for ensuring adaptability and scalability.
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