ECTD v4.0 marks a turning point in regulatory submissions — this article outlines the upcoming global timelines (Japan’s PMDA making it mandatory in 2026, other regulators following suit), key structural changes like single XML backbone, Context of Use (CoU), controlled vocabularies, and enhanced document reuse. Essential reading for pharma teams preparing for compliant, efficient fil... https://japan.freyrsolutions.com/blogs/how-ectd-v4-0-is-reshaping-regulatory-submissions-what-pharma-needs-to-know-in-2025