Submission Templates List

Submission templates provide schedules, tasks, folders, and information that are copied to a submission project when it is created from the template.

Required access roles: Regulatory Administrator or Regulatory Lead (view only submission templates in In Work state)

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access the list of all submission templates:

  1. Click Home .
  2. In the navigation pane, click Configurations to expand the category.
  3. Click Submission Templates.

To access this list from the home page:

  1. View the Market Registration home page.
  2. Select the Submission Templates tab.

This topic describes:

This page discusses:

See Also
Submission Template Properties
Regulatory Categories List

Columns

SectionColumn NameDescription
NameThe automatically-generated name of the submission template. Click to view the Properties page.
TypeThe type of template. The type is either Submission Template, or a subtype of submission template.
RevisionThe current revision of the submission template.
TitleA descriptive name for the template.
StateThe current lifecycle state of the template:

StateDescription
In WorkThe template can be used to create submission projects.
DraftThe template is still being defined, or for some reason should not be used for creating submission projects.

Regulatory ActivityCategoryThe regulatory activity category, such as Initial Submission or Renewal, that this template supports.
Sub CategoryThe subcategory for the above category.
Regulatory CategoryThe category, such as Drug or Medical Device, that this template is designed for. The authorization process and requirements vary for different categories. Click to view the Properties page for the category.
Submission TypeThe type of submission, such as 510K for the FDA or Centralized Procedure for the EMA, that this template will be used to create. Click to view the Properties page for the type.
Registration FeeThe fee for submissions created based on this template.
DescriptionA description of the purpose for this template.
OwnerThe person responsible for maintaining the template. Click to view the Properties page for this person.

Actions/Toolbar Commands

Required access roles:

  • Create submission templates: Regulatory Administrator
  • Delete submission templates: Submission template owner with Regulatory Administrator role
  • Remove submission templates: Regulatory Administrator
  • Copy submission templates: Regulatory Administrator
  • Edit submission templates: Submission template owner with Regulatory Administrator role

ActionDescriptionFor More Information
Create Submission Template Creates a submission template. Creating Submission Templates
Delete Selected Deletes the selected submission template. Click OK to confirm.

You can only delete templates if you own them, no submission has been created from the template, and it is in the Draft state.

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Remove Selected Removes the selected submission template but does not delete it from the database. Click OK to confirm.-
Copy Creates a new submission template by copying the selected template. The copied submission template includes the Schedule tasks, regulatory contexts, regulatory guidelines, countries, and languages from the source template.

For example, if the regulatory authority released a new revision of a guideline, you would copy the existing submission template and add the new guideline.

Copying Submission Templates