Japan's PMDA is mandating eCTD v4.0 implementation by April 1, 2026, marking a significant shift from eCTD v3.2.2. This transition introduces enhanced metadata usage, document reusability, and global harmonization with ICH, US FDA, and EMA standards. The article outlines key differences between v3.2.2 and v4.0, the drivers behind the change, and the strategic steps pharmaceutical and ... https://japan.freyrsolutions.com/blogs/ectd-v4-0-in-japan-navigating-the-2026-regulatory-transformation