When working with Japanese regulatory submissions, Vault can generate JP eCTD XSD 1.0 compliant XMLs for submission to the Pharmaceuticals and Medical Devices Agency (PMDA). Submissions Publishing also provides additional functionality to continuously update the cumulative submission XML to contain the complete snapshot of all documents from all submission versions. Vault validates these submissions in accordance with the JP PMDA 1.0 Validation Criteria Version.

Japanese eCTD 1.0 submissions must be queued for import in the order in which they are published and submitted to the Health Authority. This ensures that leaf lifecycle operations display properly and cross-document navigation functions as expected. If you remove and re-import submissions, you must also remove and re-import subsequent submissions in the application. This is only applicable for eCTD submissions.

About Node Extensions & Study Tagging Files

The Japanese eCTD specification prohibits Study Tagging Files (STFs) and highly discourages node extensions.

About Content Plans for Japanese Submissions

After the initial submission is published, users can create subsequent submission content plans that contain new nodes or content plan items to make corrections and updates to the original version. Each time an update to the submission is published, Vault regenerates the cumulative XML backbone to contain all content plan leaves and documents from the previous submissions as well as the current submission.

Working with Content Plans

Because Japanese submissions are sequential and publishing assumes that past submissions are no longer subject to change, you must set the Enable Continuous Publishing field to No on any Submission records that have already been submitted.

The Japanese regional XML also requires that you include all nodes in the initial submission, even if there are no underlying documents. When you create the initial submission, it is important that the root content plan contains all of the relevant content plan sections within Module 1. This will ensure that Vault generates a regional XML that includes the content plan sections, even without underlying content plan items.

Note that you should not include a content plan item for the cover.pdf file in the Module 1 content plan section. The cover.pdf file contains an MD5 checksum for the Index XML, and you cannot include it in advance. Instead, you must add this file to the published output manually.

Copying a Content Plan

When copying a content plan from a submission for another country, Vault removes all country-specific data, including STFs.

Viewing & Managing Submission Administrative Information

Vault supports viewing and managing Submission Administrative Information for JP 1.0 XSDs. See Managing Submission Administrative Information for details.

Additional Submission Types

Japanese applications often include multiple submissions. After the first submission, subsequent submission updates are used to correct or add information to the original submission version.

In the Submission Administrative Information viewer, Vault automatically populates the Primary Submission Type. Vault also supports additional submission types. Open the Submission Administrative Information viewer and update the Additional Submission Types field to apply these types.