EMA Calls for User Testing of FHIR Import for Electronic Product Information (ePI)

Details

The European Medicines Agency (EMA) has issued a call for interested parties to participate in user testing related to the import of electronic product information (ePI) into its Product Lifecycle Management (PLM) portal. The scope of the testing covers several key technical areas: creating ePI in FHIR XML format, utilizing ePI instructions on the PLM portal, applying the FHIR ePI implementation guide, and finally, importing the FHIR data into the PLM portal. This initiative aims to standardize and streamline the management of digital information throughout a product's lifecycle. It highlights regulatory bodies leading the establishment of standardized data exchange processes. Interested parties can register for this activity until May 19, 2025. The project is significant as it represents a major step toward realizing digital information sharing across the entire medical product life cycle, demonstrating international regulatory efforts using the FHIR standard.