Create eCTD 4.0 Submission

The Create eCTD wizard enables you to create, update, and organize structured and compliant eCTD assemblies.

Using standard templates, you can create folder structure, leaf elements, and metadata in an assembly.

To create an eCTD assembly:

1. Click a link for the sequence, assembly or assembly plan from which you want to create an eCTD 4.0 assembly.
2. Choose Wizards > Create eCTD. The Create eCTD wizard appears.
3. Do the following:

   Option	Action
   In the Assembly Name box:	Enter a name for the assembly.
   From the Available countries box:	Select the appropriate countries and move them to the Selected box.
   To remove countries from the Selected box:	Select them and move them back to the Available box.
   Option	Action
   Next to Template Selection:	Select the template on which to base the eCTD 4.0.
   	Note: The eCTD 3.2 templates and the eCTD 4.0 templates are loaded separately in the wizard based on the Sequence Standard Type.

   Note: Using the Create eCTD Wizard, you can select a template other than the default template to use with the assembly, and that selected template will persist as the default whenever you run the Create eCTD Wizard for that assembly.

4. Click Next .

   The Select Attributes page appears. The region for which you are creating the eCTD determines the attributes that appear in the wizard. Enter details as necessary.

5. Click Next.

   The Set Application Metadata page appears. The type of assembly for which you are creating the eCTD determines the attributes that appear in the wizard. Enter details as necessary.

6. Click Next.

   The Select Sections page displays all of the available CTD sections you can add to the assembly.

7. Select the individual folders and subfolders for the eCTD.

   — For existing, life cycle or non-life cycle sequence assemblies, any section folders that already exist in the assembly are not available.

   — Selecting a top-level section automatically includes all the subsections for that folder.

   — To update the metadata values in sections that already exist, or to add the subsections to existing sections, select the checkbox next to the existing sections that need to be updated.

   Tip: Folders or leaves that are copied from the template appear in the same order as in template. New sections, folders or leaves that do not belong to any template are placed at the top of the list.

8. Click Next.

   The Select Sets of Submission Metadata page appears. If you have included any of the repeatable assembly sections, they are displayed.

9. Enter the number of sets of information for each repeatable section. In some instances, the metadata may be dependent on a section being created or on one that already exists. A list of the repeating sections can be customized based on the regulatory specification updates. To customize the repeatable sections as per your requirements, contact your business support representative.
10. Click Next.

    The Set Submission Metadata page appears.

11. Select values for the attributes. Use + or - to expand or collapse the field groups.

    A list of the fields can be customized based on the regulatory specification updates. To customize the fields as per your requirements, contact your business support representative.

    Note: To pre-populate the values, it is recommended that the Sender-defined Keywords are created before using the Create eCTD wizard.

12. Click Next.

    The Confirmation page appears.

13. Click Next.

    The Summary page displays a message indicating that the eCTD information has been saved to the assembly.

14. Do one of the following: