Japan Moved New eCTD Drug Applications to v4.0 Only From April 2026

Industry commentators have described Japan as leading the global move to eCTD v4.0. Secondary summaries of the Japanese notices report that an MHLW notification issued in February 2022, numbered 0218-4, allowed the former eCTD format to be used during a transitional period that ran until 31 March 2026. A PMDA symposium briefing in November 2025 is reported to have stated that, for applications filed from April 2026, only eCTD v4.0 is accepted.

This brief relies on secondary sources for these dates, because the MHLW notification and the PMDA implementation guide could not be retrieved directly during preparation. The dates are, however, reported consistently across several consultancy and vendor publications, and no source reviewed suggested that the April 2026 date had been postponed.

Japan reached this point after a longer preparation phase than other regions. Reports describe a pilot in 2021, followed by voluntary acceptance of eCTD v4.0 submissions from 2022. That four-year period gave sponsors and software vendors time to build and test Japanese v4.0 capability before the cutover.

The cutover applies to new applications filed with PMDA in eCTD format. Sources describing PMDA’s implementation material frame it around pharmaceutical applications. One analysis notes that the cited PMDA material does not state that the April 2026 cutover extends to medical devices or in vitro diagnostics, while some vendor publications describe a broader mandate. Device and diagnostic manufacturers should therefore confirm their own position with PMDA rather than assume the drug rules apply.

Applications that began in eCTD v3.2.2 are reported to continue in that format throughout their lifecycle. Several sources advise companies to confirm, in the MHLW and PMDA notices, how dossiers already maintained in v3.2.2 are handled, particularly for later partial change applications. Sources also report that there is no direct migration path from the older Japan-specific JP 1.0 format to eCTD v4.0.

Some publications describe the April 2026 date as a mandate for all submissions, while others limit it to new applications or to drug applications. The narrower reading, applying to new pharmaceutical applications, is the one supported by the reports of PMDA’s own briefing.

The Japanese timeline, as reported by secondary sources, has four main points. A pilot of eCTD v4.0 took place in 2021. Voluntary acceptance of eCTD v4.0 submissions began in 2022. An MHLW notification dated February 2022, reported as number 0218-4, set a transitional period during which the former eCTD format could still be used, ending on 31 March 2026. From April 2026, new applications are reported to be accepted only in eCTD v4.0.

By comparison, FDA has accepted eCTD v4.0 optionally since September 2024 and began supporting forward compatibility on 16 October 2026, without setting a mandatory date, and EMA opened optional v4.0 submissions for new centralised applications on 22 December 2025. Japan is therefore the region where sponsors are most likely to have prepared a production v4.0 submission first, and lessons from Japanese filings may be useful when planning for other regions.

Sponsors should note that the Japanese implementation guide and controlled vocabulary can be revised, and that the version applicable on the filing date should be used.

For sponsors planning Japanese filings, the practical effect is that a new application cannot be prepared by reusing a v3.2.2 publishing workflow. The dossier must be built as a v4.0 submission that meets the Japanese regional requirements. Sources note that PMDA uses a Japan-specific controlled vocabulary, so the regional metadata differs from that used for FDA or EMA v4.0 submissions even where the underlying CTD documents are the same.

Global sponsors may therefore find themselves running v4.0 for Japan, optional v4.0 for the US and the EU, and v3.2.2 elsewhere at the same time. Document content and the CTD module structure are shared, which reduces duplication, but publishing, validation and lifecycle tracking need to be managed separately for each region. Sponsors that rely on local partners or service providers for Japanese publishing should confirm that those providers are working to the current Japanese implementation guide and controlled vocabulary.

For medical writers and authors, the transition has limited direct effect on content. It does, however, increase the value of consistent document granularity, titles and metadata, because v4.0 relies more heavily on structured information about each document than v3.2.2 did.