With the PMDA mandating eCTD v4.0 by April 1, 2026, Japan is moving beyond incremental updates toward a full-scale transformation of regulatory submissions. This article outlines the differences between v3.2.2 and v4.0, the key drivers (like lifecycle management, metadata usage, and global alignment), the timelines for both Japan and other major regions, and strategic steps companies ... https://japan.freyrsolutions.com/blogs/ectd-v4-0-in-japan-navigating-the-2026-regulatory-transformation