Creating Submissions

For the first market authorization for a product, you create a submission project using the initial submission activity category. Market Registration automatically creates a submission master record associated with that submission project when you promote the project to the Assigned state. For subsequent submissions, such as variations or renewals, you create submission projects within the context of the submission master record or from a regulatory request. You cannot create other types of submissions until the initial submission has market authorization.

Required access roles: Regulatory Lead (to create a submission project from a regulatory request in the Review state), or Regulatory Lead or Regulatory User (to create a submission project)

See Also
Creating Submission Tasks
  1. Create a submission project in one of the following ways:

    To create an initial submission or restricted authorization submission:

    Click Add > Market Registration > Create Submission.

    Or:

    1. View the list of submissions. See Submissions Page.
    2. From the Actions menu or toolbar, select Create Submission.

    To create a submission from a submission master record:

    1. View the list of submissions for a submission master record. See Opening a Submission Master Record.
    2. From the Actions menu or toolbar, select Create Submission >, then select the name of the regulatory activity category. You can create a submission that uses any regulatory activity category other than Restricted Authorization.
      Note: You can only choose Commitment if you selected an existing submission project.

    To create a Commitment submission as a related submission:

    1. Open the required submission. See Opening a Submission.
    2. In the navigation pane, click Regulatory Information.
    3. Click the Related Submissions page tab.
    4. From the page Actions menu or toolbar, select Create Commitment.

    To create a Renewal submission from a market authorization:

    1. View the Market Authorization renewal list. See Market Authorizations Renewals List.
    2. Select the market authorization.
    3. From the page toolbar, select Renewal .
      Note: You can only create a Renewal submission from market authorizations that are current or have a renewal date that is not expired, that do not already have an Active Renewal submission created from them, are in the Released state, and are not Restricted in Scope.

  2. Enter these details:

    SectionField NameDescription
    PolicySubmission projects use the Project Space policy. If your organization defined custom policies, select the needed one from the list.
    TitleEnter a descriptive name for the submission.
    Regulatory ActivityRegulatory Activity CategoryChoose the regulatory activity category defined for this submission. The category you choose updates the values for the subcategory.

    If you started this task from the global toolbar or from the list of all submissions, you can only choose Initial Submission or Restricted Authorization. If you started this task from the list of submissions for a submission master record, you chose a category when you opened the dialog box and cannot change it here.

    Regulatory Activity Sub CategoryChoose the subcategory for the activity category. Not all categories have subcategories.
    Note: You can also selected the blank range value to create a submission for the medical devices.
    Regulatory Context

    This section does not appear when creating a Commitment submission from the Related Submissions page for a submission or when creating a Renewal submission from a market authorization.

    		Regulatory ContextIf you select a submission template before selecting a regulatory context, the app sets the regulatory context as defined in that template and you cannot change it. If you do not choose a submission template, you must select a regulatory context.

    Click to search for and select the regulatory context under which this submission will be prepared. The app fills in the Regulatory Category, Submission Type, and Regulatory Authority fields from the selected context.

    You cannot add a regulatory context if it includes a derived submission type (that is, the submission type depends on another submission type).

    When creating a submission from a submission master record, the regulatory context only shows for an Initial Submission type.

    All the regulatory contexts that has derived regulatory submission type are available to select.

    The regulatory contexts are not available to select for this submission master record if the derived regulatory submission type objects are not present.

    For all other types, the regulatory context defined for the submission master record is used for the new submission.

    When creating a submission from a regulatory request, it is created as an Initial Submission type. The regulatory request must be in the Review state to create a submission from it. Only the regulatory contexts associated with the regulatory request type associated with the regulatory request are available.

    Regulatory Category
    Submission Type
    Regulatory Authority
    TemplateSubmission TemplateClick to search for and select the submission template. If you selected a regulatory context, the search only lets you select from templates associated with that context.

    All tasks in the Schedule page for the template are included in the submission. All controlled folders and any workspace folders are included in the Folders page for the submission. Any mapping between tasks and controlled folders (the volume for the task) is also copied to the submission.

    The submission inherits the regulatory contexts, countries, languages, schedule structure, folders, bookmarks, registration fee, publishing file format, and regulatory guideline from the template.

    If you want to the submission to be published in the eCopy format, select a submission template that is already configured with that option; otherwise, the default format is "Paper-based" and you must edit the publishing file format on the Regulatory Information Properties Page.

    If you do not select a template, the submission includes all countries and languages associated with the regulatory authority (part of the regulatory context). Initially, the registration fee is $0, and the publishing file format is paper-based.

    DescriptionType a detailed description of this submission project.
    SchedulingSubmission DateSelect the date used to schedule the submission project. Click to choose a date.
    Schedule FromSelect how to use the Submission Date to schedule the submission project:

    OptionDescription
    Project Start DateUse the Submission Date as the date on which to start the submission project scheduling. It will be scheduled forward from this date.
    Project Finish DateUse the Submission Date as the date on which to end the submission project scheduling. It will be schedule backward from this date.

  3. Click Done.

The submission project is created. The schedule for the submission includes milestones defined for these purposes:

  • Dossier Ready
  • Dossier Published
  • Dossier Submitted
  • Dossier Received
  • Market Authorization

If you selected a submission template, the submission inherits these items from the template:

  • Languages
  • Schedule (work breakdown structure)
  • Folders
  • Bookmarks
  • Registration fee
  • Publishing file format
  • Regulatory guidelines
  • Documents in submission template folders are referenced, but not copied, into the submission folder.
  • Any task deliverables are copied, not referenced, as submission task deliverables.
  • For a submission created without a submission master record, the regulatory contexts and countries from the template
  • For a submission created from a submission master record, the regulatory contexts and countries from the submission master record (not the submission template) are used instead.

Submission projects created from a regulatory request inherit the products and countries from the regulatory request. They cannot be changed in the submission.

Submission projects that are configured to use the eCopy publishing format have two local folders that are created automatically:

  • Published Dossier: This folder is populated once the submission is published.
  • Submission Dossier: This folder has two virtual folders: STATISTICAL DATA (which includes all statistical type files) and MISC (which includes all video and image files).

Note: After creating the submission project, you still need to:
  • Add Project Members. These users must have the Regulatory User role. See Project Management User's Guide: Adding Members to a Project.
  • Update the Schedule page for the regulatory calendars, phases, milestones, and tasks required to complete the submission and assign them to project members. If you selected a submission template, the Schedule page might already be defined and you only need to assign the tasks. See Schedule for a Submission Project.