ECTD v4.0 introduces a transformative approach to regulatory submissions, emphasizing metadata-driven structures, enhanced document reuse, and improved interoperability across global agencies. This evolution aims to streamline the submission process, reduce redundancies, and facilitate smoother regulatory reviews. With major agencies like the FDA and PMDA adopting eCTD v4.0, pharmaceu... https://japan.freyrsolutions.com/blogs/how-ectd-v4-0-is-reshaping-regulatory-submissions-what-pharma-needs-to-know-in-2025