Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is set to fully implement eCTD v4.0 by April 1, 2026, marking a significant shift from the previous eCTD v3.2.2 format. This transition introduces enhanced metadata usage, document reusability, and global harmonization with ICH, US FDA, and EMA standards. The blog outlines the key differences between eCTD v3.2.2 and v4.0, the d... https://japan.freyrsolutions.com/blogs/ectd-v4-0-in-japan-navigating-the-2026-regulatory-transformation