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eCTD 4.0 Explained: FDA, EMA and Japan Deadlines, Key Changes and What It Means for Regulatory Affairs Careers
**eCTD 4.0** is the next-generation global standard for electronic pharmaceutical regulatory submissions, replacing the document-centric **eCTD 3.2.2** format used since 2008. It affects regulatory affairs professionals, publishing specialists and every company submitting dossiers to the **FDA**, **EMA**, **PMDA** and other health authorities. The **FDA** has accepted eCTD 4.0 for new applications since **16 September 2024**; **Japan** targets a mandate by **April 2026**; and
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