We are proud to announce our participation in the upcoming User Acceptance Testing (UAT) organized by the European Medicines Agency (EMA) for the FHIR import of electronic Product Information (ePI).
This initiative represents a significant milestone in the digital transformation of regulatory processes. The newly developed FHIR import functionality will enable the seamless upload of ePI in FHIR XML format directly into the Product Lifecycle Management (PLM) portal. This step is crucial in enhancing data interoperability, improving information consistency, and streamlining submissions across the EU regulatory network.
The UAT will take place from 16 to 27 June 2025, during which Asphalion will be actively involved in testing the new functionality. We will contribute by reviewing and validating the FHIR implementation guide, identifying usability improvements, and reporting any issues or bugs encountered. This process will help ensure the robustness, usability, and regulatory compliance of the new system before it is rolled out more broadly.
Our participation reflects Asphalion’s dedication to driving innovation in the regulatory field and supporting initiatives that aim to simplify and modernize the way medicinal product information is handled. As a long-standing partner to the life sciences industry, we are committed to contributing our expertise to projects that bring added value to both authorities and stakeholders.
Stay tuned—we’ll be sharing updates on our insights and findings throughout the testing phase.
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