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EMA to Host Information Session on FHIR for PLM Portal eAF

Information session on FHIR for PLM portal web-based electronic application

An information session was held regarding the use of FHIR for electronic application forms (eAF) within the PLM portal.

August 26, 2025European Medicines Agency (EMA)

Summary

The European Medicines Agency (EMA) is organizing an information session, through its Digital Business Transformation Task Force, regarding the use of FHIR XML in a Product Lifecycle Management (PLM) portal electronic application form (eAF). The webinar will take place on December 3, 2024.

Key Players

European Commission

Details

The European Medicines Agency (EMA), via its Digital Business Transformation Task Force, announced an information session concerning the PLM portal web-based electronic application form (eAF) utilizing FHIR (Fast Healthcare Interoperability Resources). This webinar is scheduled for December 3, 2024, from 11:00 to 12:00 CET. Participants will receive updated information on FHIR XML. The primary target audience is NCA technical staff, though the content may also interest other NCA staff members. This initiative highlights the push toward standardizing data exchange and electronic application processes within regulatory bodies using international standards like FHIR. The use of FHIR suggests a global effort to create interoperable digital platforms for drug approval processes. In Japan, where standardization and advanced electronic submission systems are critical in healthcare IT, this international trend provides valuable insight into how major regulatory agencies are adopting modern interoperability standards to streamline complex administrative workflows. Registration must be completed by November 29, 2024.

Technology Note

FHIR(Fast Healthcare Interoperability Resources)は医療データ交換の国際標準。このエントリの関連技術: FHIR

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