When working with Australian regulatory submissions, Submissions Publishing allows you to generate AU eCTD XSD 3.1 compliant XMLs for submission to the Australian Therapeutic Goods Administration (TGA). Vault can validate these submissions in accordance with the AU TGA v3.1 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extensions & Study Tagging Files
In certain situations, the Australian 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 AU 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 AU 0.9, 3.0, and 3.1 XSDs. You can also manage Submission Administrative Information for AU 3.1 XSDs.
When you manage Submission Administrative Information for Australian submissions, the viewer automatically groups the Sequence Type and Sequence Description attributes in the Sequence Type row to support worksharing. Vault populates each attribute based on the submission’s Submission Type and Submission Subtype, respectively.
You can add an override to support additional Sequence Types and Sequence Descriptions in work-grouping submissions. When you add an override for the Sequence Type, Vault displays a pre-filtered list of Controlled Vocabulary records with Submission Type and Submission Subtype set for Controlled Vocabulary Type, as well as AU selected for HA Code Source.