Processing a Submission: Initial Submission

Regulatory Leads create submission projects for a specific regulatory context and regulatory activity category as defined in the regulatory guidelines. Submission projects also include a schedule phase for preparing and submitting the dossier, and a regulatory calendar phase for managing the regulatory authority tasks and timetable and any interactive review cycles.

This topic describes the basic process for submitting a product to the regulatory authority to obtain market authorization. Your process should be customized for the specific regulatory context and the internal business processes your company has established.

The stages in this procedure are as follows:

Before you begin:
  • Product Manager defines the product that is the subject of the submission.
  • Regulatory Administrator defines a submission template for the regulatory context and the specific regulatory activity category. (Optional)
  • Regulatory Administrator defines a regulatory calendar template. (Optional)

Create a Submission

  1. Create a submission based on a submission template. See Creating Submissions.

    You can create a submission with a template, but using a template allows you to take advantage of many predefined items required by the submission, and implements a repeatable process. The template automatically copies these items to the submission project:

    • Regulatory contexts
    • Regulatory guidelines
    • Countries
    • Languages
    • Folders

  2. Create folders and content.
  3. Connect the submission project to the product for which it manages the regulatory approval process. See Products List for a Submission.
  4. Define the schedule for the submission project. See Schedule for a Submission Project.

    When created based on a template, the schedule could already include tasks, phases, and milestones. For the specific submission project, add additional items to the schedule or remove any unneeded items.

    Important: Do not remove or delete the milestones created by the submission (Dossier Ready, Dossier Published, Dossier Submitted, Dossier Received and Market Authorization). Market Registration verifies that each prior milestone is complete before you can promote a milestone. If you have not completed the Dossier Ready milestone (or removed it), you cannot complete the Dossier Published or any subsequent milestones.

  5. Use the Timeline page to add a regulatory calendar template to the schedule. See Timeline for a Regulatory Calendar Page.

    The regulatory calendar template could also contain phases and milestones. Add or remove items as needed for the specific submission project.

  6. Use the Project Management risk management tools to track any risk benefit assessments required by the regulatory authority. Access these tools on the Issues & Risks page tab on the Collaboration category.

Manage Regulatory Information

For a submission project that supports multiple countries, such as the Centralized Procedure in Europe, the regulatory context relates all countries to the submission project.

  1. Depending on the submission type (part of the regulatory context), define the regulatory information:

    • To support the Centralized Procedure submission type (defined by the EMA):
      • Define the leading country (the rapporteur).
      • Define the following countries (the co-rapporteur).
    • To support the Mutual Recognition Procedure or Decentralized Procedure submission types (defined by the EMA), add countries to the submission project to define them as referent member states.

  2. For the relevant products, define the required regulatory information.

    Context ItemRegulatory InformationWhere Defined
    SubmissionPublishing file formatRegulatory Information category, Regulatory Information page tab
    ProductStorage conditions for after use or before use, and for various environmental conditionsRegulatory category, Storage Conditions page tab
    Indications for use of the product (medical device, pharmaceutical, supplement, and so on)Regulatory category, Indications page tab
    Orphan DrugRegulatory category, Properties page tab
    International Birth DateRegulatory category, Properties page tab

  3. Promote the submission project to the Ready state.
    When the submission project reaches the Ready state, Market Registration creates these additional items:
    • Submission Master Record to bind the market authorization for this product with future submissions (such as renewals, variations, or repeals)
    • Market Authorization Change in the In Work state to define the details for product/submission
    • Market Authorization in the In Work state

Manage Requests for Work

Regulatory Leads can create regulatory requests to assign tasks related to preparing the submission dossier or answering review questions. Regulatory requests can be tied to the submission project in general, to specific phases, tasks, or milestones in the schedule, or to the product (the subject of the submission project).

Before you begin: A Regulatory Administrator must have defined required request types and request queues. See Managing Regulatory Request Types and Queues.
  1. Navigate to the item most related to the task.

    • Regulatory work not related to a specific submission: View the Regulatory Request page and select the Initiated view.
    • For the submission: click Regulatory Information in the navigation pane, then click the Requests page tab.
    • For a specific milestone, phase, or task:
      1. Click Schedule in the navigation pane.
      2. Click the schedule item name.
      3. Click Requests in the navigation pane.

  2. Create the regulatory request. See Creating Regulatory Requests.

    Include explicit instructions in the request so that the assignee can properly complete the task.

    You can specify a person for the request, or allow Market Registration to submit the request to a queue where any member of the queue can accept the request.
  3. Fill out the reviewer questionnaire (if one was defined for the request type).
    The answers to the questions can add routes or reviewers to the request.
  4. If the request was assigned to a specific person, that person:

    • Accepts the request
    • Rejects the request
    • Assigns the request to a different person (or reassign if the request had been accepted)

    If the request was assigned to a queue, it shows up in the list for any person in that queue as though it was assigned to that person.

    If the assignee rejected the request, you can assign it to someone else, or assign it back to the original person (if appropriate).

  5. The person assigned to the request completes the task and submits a deliverable. The required reviewers evaluate the deliverable and approve it.
    If you created the regulatory request in the context of a submission, or a schedule item (milestone, phase, or task), that item cannot be completed until all regulatory requests associated with it are completed.

Submit the Dossier

Each milestone in the schedule must be completed before you can promote the next milestone.

  1. Complete all tasks required for the Dossier Ready milestone. The milestone might have regulatory requests, routes, and checklists that must be complete prior to marking the milestone as complete. When you enter an End Date in the Schedule, that milestone is promoted to Complete.
    Market Registration promotes the submission project to Active.
  2. Complete all tasks required for the Dossier Published milestone and enter the End Date in the schedule.
  3. Complete all tasks required for the Dossier Submitted milestone:

    1. On the Regulatory Information page for the submission project, enter the Authority Application Number.
    2. On the same page, select Evaluation for the Dossier Submitted status.
    3. In the schedule for the submission project, enter the End Date for the Dossier Submitted milestone.

  4. Complete all tasks required for the Dossier Received milestone.

At this point, the tasks in the regulatory calendar phase shown on the Timeline page monitors the progress of the submission project.

Manage Correspondence

During the submission process, communication between the applicant company, the regulatory authorities, and any other concerned parties must be tracked. The correspondence becomes permanently associated with the submission, so that years in the future (when submitting renewals or variations or any other regulatory activity), the record of the communication is available.

Before you begin: Contacts (the people at the regulatory authority or other companies) must be defined either at the global level (listed on the Contacts page tab on the Market Registration home page, or on the Contacts page tab for the specific submission project.
  1. When communication occurs, create a correspondence record. See Correspondence List.

    For correspondence not specific to a submission, create the correspondence from the Market Registration home page. You can later associate that correspondence to a submission or submission master record.

  2. If a correspondence created for a submission does not involve all products or countries relevant to the submission, use the Related Items page tab to remove the irrelevant products or countries.

After a correspondence is created, it cannot be deleted. The correspondence is a permanent record.

Manage Questions and Answers

During the regulatory review of the submitted dossier, the regulatory authority can submit questions to obtain additional information. You should add all questions, and the answers to those questions, to the submission project. Use an Interactive Review phase to manage the question-and-answer process.

  1. View the page for the submission project.
  2. Click Schedule on the navigation pane.
  3. Add an Interactive Review phase to the schedule.

    If the phase stops the regulatory clock (the regulatory authority will inform you if it does), add it on the Timeline page. See Timeline for a Regulatory Calendar Page.

    If the regulatory clock does not stop, you can add the phase on the Timeline or Schedule page. See Schedule for a Submission Project.

  4. On the Schedule page, select the Interactive Review phase and add a Review Question for each question received from the regulatory authority. See Managing the Question and Answer Phase.

    Copy the text of the question from the regulatory authority into the Question Text field, either when you create the question, or in the properties page for the question.

    Create a correspondence for the document received from the regulatory agency containing the review questions. See Correspondence List.

  5. Use the Requests page for the Review Question to create and submit regulatory requests to people responsible for generating the answers to the questions. See Creating Regulatory Requests.
  6. Process all Review Questions through their lifecycles. Deliverable documents should be added to the Review Question, with a brief summary entered in the Answer Text field on the Properties page for the Review Question.
  7. Add a regulatory milestone to the interactive review phase with the regulatory purpose defined as Response. When all Review Questions are complete, mark this milestone as complete.

If the clock was stopped for the Interactive Review phase, as soon as the phase is marked complete, the clock continues from where it stopped.

Enter the Market Authorization Details

When you receive market authorization from the regulatory authority, enter the details in the market authorization change.

  1. Complete all tasks required for the Market Authorization milestone on the Schedule page for the submission project.

    1. On the Regulatory Information page for the submission project, select Approved for the Results status.
    2. In the schedule for the submission project, enter the End Date for the Market Authorization milestone.

      Market Registration promotes the submission project to Review, and adds a route to the lifecyle page.

    3. All people assigned to review the submission results must approve their tasks in the route.

  2. Enter all details on the Properties page for the market authorization change. See Editing Properties for Market Authorizations and Market Authorization Changes.
  3. On the Market Authorization Change page for the submission project, select the change and click Approve For Update.
    Market Registration marks the Dossier Submitted field for the submission project (on the Regulatory Information page) as Consensus Reached.

Market Registration promotes:

  • Market authorization change to Closed
  • Market authorization to Released
  • Submission to Complete