3 Insights from Industry: Getting Ready
for eCTD 4.0 in Japan

Dec 08, 2025 | Yohei Saito

The transition from eCTD 3.2 to eCTD 4.0 is a key driver of global standardization efforts driven by ICH, and is one of the highest-priority areas of interest for regulatory affairs (RA) teams responsible for global submission activities. While universal global deadlines for eCTD 4.0 are a few years away, Japan will be the first country to enter the mandatory period in April 2026. In preparation, some companies have already submitted eCTD 4.0 dossiers, and many others are currently reviewing or implementing corresponding systems and operational frameworks.

Veeva RIM has already released eCTD 4.0 support for Japan, and during a recent User Group Meeting in Japan, participating companies shared insight into how they are advancing their internal eCTD 4.0 initiatives. Twenty-seven pharmaceutical companies participated, about half of which were Japan affiliates of global pharmaceutical organizations.

The discussion focused around three key topics:

• eCTD 4.0 preparedness and education
• Conceptual shifts, particularly around XML structure
• Expectations for RIM systems

Read on to learn how these companies are approaching these areas.

Driving eCTD 4.0 initiatives within companies

Companies in Japan widely use training materials developed by the Japanese eCTD Industry Working Group for internal education. Many Japan affiliates of global pharma companies participate in this working group, which prevents any significant knowledge gaps.

Approximately one-third of the companies participating in the RIM User Group Meeting plan for their Japanese RA teams to be involved in some form of internal knowledge transfer within their global-level eCTD 4.0 initiatives. This was a common trend regardless of the companies’ headquarters location (Japan/EU/U.S.), and many companies are primarily focusing on the U.S. as the next market after Japan. However, within this third, a subset of companies indicated awareness of the mandatory period for centrally authorised products (CAPs) scheduled by the EMA in 2027, leading to more concrete internal requests for knowledge transfer.

Meanwhile, several participating companies intend to utilize eCTD 4.0 outsourcing services — such as those provided by CROs — to support Japan’s eCTD 4.0 transition period.

Adapting to conceptual shifts in eCTD 4.0

While the transition from eCTD 3.2 to 4.0 involves many changes, the discussion particularly focused on the XML structure. eCTD 4.0 replaces the Leaf element concept used in eCTD 3.2. eCTD 4.0 introduces new concepts for capturing the document separately from its metadata, the Context of Use (CoU). eCTD 4.0’s Submission Unit XML structures data differently, making the file less human readable.

There was a shared understanding that RIM system vendors should implement most of the new functions in eCTD 4.0 through publishing or archiving systems. However, participants also discussed that the conceptual change in XML could potentially affect pharmaceutical companies’ operational design and quality-checking processes. Specifically, given the 350+ validation checks currently being used by the PMDA for eCTD 4.0 (as of November 2025) and the non-human readable XML status, some suggested that these expanded validations might partially replace the dossier quality checks that were previously performed manually under eCTD 3.2.

At present, there remains a clear operational inertia from the eCTD 3.2 era, during which human-readable XMLs were routinely subject to quality checks. On the other hand, several participants expressed concerns that displaying all data contained in the non-human-readable XMLs of eCTD 4.0 within an archive viewer may make them difficult to interpret.

This suggests a potential need for eCTD 4.0 archive viewers to selectively extract and present the appropriate information from these non-human-readable XMLs in a human-readable format.

Expectations for RIM systems in the eCTD 4.0 era

Based on these observations, a full RIM system with an Archive that allows customers to review metadata without reading the XML would play an even greater role — specifically, translating the non-human-readable XML into a human-readable format.

Furthermore, because validation in the eCTD 4.0 era generates a larger set of validation results based on the non-human-readable XML, the ability for publishers to review validation results immediately during the submission-creation phase will be a critically important operational requirement.

Participants with direct experience preparing for eCTD 4.0 implementation expressed expectations for RIM systems capable of suggesting automated corrections based on validation results in the future.

Achieving a seamless transition to eCTD 4.0

Outside Japan, the mandatory period for eCTD 4.0 adoption is still years away, and currently, health authorities other than the PMDA have not shown a significant increase in validation checks with eCTD 4.0.

Therefore, it may take several years to evaluate whether moving from “non-human readable XML” to “machine readable XML,” and from “comprehensive validation” to “system-suggest correction,” is a globally valid expectation.

Veeva RIM has already released eCTD 4.0 support for Japan and plans to expand support to the U.S. next. By continuously supporting customers for a seamless transition to eCTD 4.0, and facilitating the process from theory to practice and from practice to maturity, Veeva will support the maturation of the eCTD 4.0 era in the industry.

If you are interested in the specific configuration details for eCTD 4.0, please contact your Account Partner or Managed Services representative. Additionally, Veeva Connect continues to share the eCTD 4.0 transition timelines for countries around the world, so please feel free to join the community.