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Fig. 6 | AAPS Open

Fig. 6

From: Structured content and data management—enhancing acceleration in drug development through efficiency in data exchange

Fig. 6

Summary of past, present, and future regulatory filing processes. While physical, paper-based submissions were the standard operating model in the past, the current regulatory framework in many major markets supports electronic submission of regulatory information in eCTD format. The conversion to an electronic system has ushered in multiple benefits, but there are ways to improve. In the future, electronic filings can achieve standardization and interoperability across data systems via HL7 FHIR, which is adapted for a real-time, cloud-based exchange ecosystem

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