Modify Regional Information

Configure regional attributes to the assembly root to easily incorporate regulatory changes.

Prerequisites

To make the Regional Information option available in the More menu of the eCTD 4.0 assembly root, you must have the CV Profile with envelope CV assigned to Publishing Settings Library.

To view or modify the regional information:

  1. On the assembly tree, select to the eCTD 4.0 assembly root folder.
  2. In the More list, click Regional Information.
  3. On the Regional Information page, click Edit.

    This option is not available if Regional Information is invoked from a locked Submitted view and sequence assembly added to a life cycle.

    Note: The regional information attributes are displayed according to the CV service configuration. If the Applicant Contact values were previously set for Regional Information and then deactivated in Data Administration, they will still be available on the attributes page and included in the published output.

  4. Modify the attributes.
  5. Click Save.