Submission Maintenance

Use Submission Maintenance pages to define:
  • Values for supporting the US eCTD Module 1 v2.3 specification (DTD 3.3). You can select these values for extended attributes of an assembly. In the eCTD wizard, you can do this after selecting the necessary template.
  • Values for supporting the CN eCTD Module 1 v1.0 specification. You can select these values for extended attributes of an assembly. In the eCTD wizard, you can do this after selecting the necessary template.
  • Fonts that you can use in tab sheets created in Calyx RIM Publisher.
Note: Viewing and modifying submission maintenance values requires specific Data Administration access privileges.

When you click a type of value under Submission Maintenance, a page opens with a table of all defined values for that type. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

On the submission maintenance pages, you can set the status of a value to active or inactive.

Note: When creating or modifying the values listed below, regions available for selection in the Region field are limited by those of a Regulatory Region type only:
  • Application Contact Type
  • Applicant Contact
  • Applicant ID
  • Application Form Type
  • Promotional Material Audience Type
  • Promotional Material Doc Type
  • Promotional Material Type
  • Regulatory Activity Lead
  • Sequence Description
  • Submission Product Type
  • Telephone Number Type