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eCTD 4.0: Redefining Regulatory Submission Strategy and Digitization
Manage episode 520983798 series 3703213
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📢 DDReg Knowledge Capsule – Episode [17]
The significant global shift toward eCTD 4.0 for regulatory dossier submissions in the pharmaceutical industry. This new standard moves regulatory management from static files to a data-driven connected information system, emphasising features like a unified XML backbone, unique document identifiers (UUIDs), and controlled vocabularies. The article outlines how eCTD 4.0 enhances traceability and reusability, requiring companies to implement new metadata governance and continuous dossier management strategies instead of traditional large, event-based submissions. Furthermore, it discusses the implementation timelines of major health authorities, such as the U.S. FDA and EMA, while offering DDReg’s services to help companies navigate the transition, which is crucial for achieving greater efficiency and compliance.
Check out For more detials
https://resource.ddregpharma.com/blogs/regulatory-dossier-digitization-how-ectd-4-0-is-redefining-submission-strategy/
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