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A Deep Dive into eCTD v4.0 Submissions: Japan’s PMDA Process & Global Differences

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Explore how Japan’s PMDA is implementing eCTD v4.0 and how its requirements compare to those of other major regulatory jurisdictions. This article details technical specifications like folder structure, XML message rules, life-cycle management, controlled vocabulary usage, validation checks, and regional subtleties. Ideal for regulatory teams preparing for compliance by 2026 and wanti... https://japan.freyrsolutions.com/blogs/a-deep-dive-into-ectd-v4-0-submissions-japan-pmda-process-and-global-differences

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