When working with Jordan regulatory submissions, Submissions Publishing allows you to generate JO eCTD DTD 1.1 compliant XMLs for submission to the Jordan Food & Drug Administration (FDA). Vault can validate these submissions in accordance with the JO FDA 1.1 Validation Criteria Version.
Note: This feature is only available on RIM Submissions Publishing Vaults.
About Node Extensions & Study Tagging Files
In certain situations, the Jordan 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 JO 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 JO 1.0 and 1.1 DTDs. Vault supports managing Submission Administrative Information for JO 1.1 DTDs. See Managing Submission Administrative Information for details.
| Submission Administrative Information | Manage Submission Information | How it is Populated |
|---|---|---|
| Application Reference Number | JDWS Application Number (application) | Populated from the xml_application_number__v on the application__v |
| Number | Application Reference Number (number) | Entered on Submissions Administrative Information and carried forward |
Adding Multiple Application Numbers
JFDA guidance allows for multiple variations of the same medicinal product to be submitted jointly, as a multiple application.
To support this scenario, you can associate multiple application numbers to JO submissions by adding overrides to the eJDWS Application Number (Application) or Application Reference Number (Number).
When you add an override, Vault maintains the existing values and includes the override to subsequent sequences without impacting any previous sequences. Similarly, when you delete an override, it remains for any previous sequences, and Vault does not include it in the current or future sequences.
Once you save the override, Vault republishes the submission and populates the overridden values after the default Application Number value in the Submission Administrative Information panel and regional XML of the selected and any subsequent submissions.