FHIR Standard for EU Drug Information: The Shift to ePI and its Technical Significance
FHIR-compliant electronic product information (ePI) mt-g medical translation FHIR (Fast
A structured, standardized basis for FHIR-compliant electronic product information (ePI) and medical translation is available.
Summary
Driven by the European Medicines Agency (EMA), pharmaceutical product information is undergoing a structured transition into Electronic Product Information (ePI) using FHIR format. This aims to transform conventional unstructured documents into highly searchable, interoperable digital data, promoting safer use of medicine.
Details
The European Union (EU) is accelerating the shift toward delivering drug information as Electronic Product Information (ePI), utilizing the Fast Healthcare Interoperability Resources (FHIR) standard. Traditionally, product information—which includes package leaflets and summaries of product characteristics—has been contained in unstructured formats like Word or PDF, posing challenges for accessibility and interoperability. The EU ePI Common Standard aims to structure this content into machine-readable data. FHIR is chosen because it is an internationally recognized standard for health data exchange, enabling seamless integration into electronic health systems. This transition allows product information to be updated in real-time, improving searchability, supporting multilingual capabilities, and enhancing overall accessibility. Furthermore, the structured nature of ePI facilitates linking with existing EMA databases (such as those based on ISO IDMP), thereby ensuring data consistency and reusability. This move is not merely digitization; it establishes a foundation for international harmonization and standardization across regulatory processes. The process involves converting and optimizing existing documents to ensure compliance with EU standards, providing technical validation and support for integration into current regulatory labeling workflows.
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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