Japan's PMDA mandates eCTD v4.0 implementation by April 1, 2026. This transition from eCTD v3.2.2 to v4.0 introduces a more meta-driven, efficient, scalable, and globally harmonized regulatory submission process. Key benefits include lifecycle intelligence, global alignment with ICH, USFDA, and EMA standards, operational efficiency, and structured content management. Companies are adv... https://japan.freyrsolutions.com/blogs/ectd-v4-0-in-japan-navigating-the-2026-regulatory-transformation