When working with Thai regulatory submissions, Submissions Publishing allows you to generate TH eCTD XSD 1.0 compliant XMLs for submission to FDA Thailand. Vault can validate these submissions in accordance with the TH FAD 1.0 Validation Criteria Version.

About Node Extensions & Study Tagging Files

The Thai eCTD specification supports both node extensions and Study Tagging Files (STFs) in the same submission. If your submission contains both node extensions and STFs, they must exist in separate content plan sections.

Copying a Content Plan for TH Submissions

When copying a content plan from another submission, Vault removes all country-specific data with the exception of the STF Content Plan Item record to support other regions that accept STFs. In order for the publishing process to work correctly for copied submissions, you must set the Continuous Publishing and Continuous Validation fields to Yes on all Content Plan Items.

Viewing & Managing Submission Administrative Information

Vault supports viewing Submission Administrative Information for TH 0.92 and 1.0 XSDs. You can also manage Submission Administrative Information for TH 1.0 XSDs. When you manage Submission Administrative Information for Thai submissions, the viewer displays additional fields based on the text in the Sequence Description. See Managing Submission Administrative Information for details.