Configuring Market Registration

Regulatory Administrators must create and configure regulatory contexts and submission templates before Regulatory Leads can create and work with submission projects.

This task shows you how to:

Before you begin: Use Geography Configuration to make sure the countries and languages you need to use in your regulatory submission projects are in the Active state.

Define Regulatory Contexts

Regulatory Administrators need to create regulatory categories, submission types, and regulatory authorities, which combine to define the regulatory context for market authorizations.

  1. Create regulatory categories and promote them to the Active state. SeeCreating a Regulatory Authority.
  2. Create submission types and promote them to the Active state. See Creating a Submission Type.

    The submission type matches those defined by the regulatory authority, such as 510 (k) for an FDA submission, or Centralized Procedure and Mutual Recognition Procedure for the European Medicines Agency.

  3. Create and configure regulatory authorities.
    1. Create regulatory authorities. See Creating a Regulatory Authority
    2. Add submission types. See Submission Types List.
    3. Add regulatory categories. See Regulatory Categories List.
    4. Add countries. See Countries Page. You add a country when you create the authority, but you can add additional countries.
    5. Add languages. See Languages List. You can add languages associated with the selected country when you create the authority, and you can add additional languages.
    6. Create reviewers: people from the regulatory authority who will review the submission dossier. See Reviewers List.
    7. Add reference documents. See Collaboration and Approvals User's Guide: Documents and Content.
    8. Promote the regulatory authority to the Active state. All attached items (submission types, countries, and so on) must be in the Active state. When you promote the regulatory authority, Market Registration creates regulatory contexts.

Market Registration creates a regulatory context for each combination of regulatory category and regulatory submission for that authority. For example, if you added two regulatory categories and three submission types, Market Registration creates six regulatory contexts.

Define Regulatory Guidelines

Regulatory authorities make their guidelines available, often as PDF files. You can create a Regulatory Guideline within Market Registration to hold that file. Each regulatory context has a specific guideline that applicants need to follow. That guideline can then be associated with any template or submission project that uses the same regulatory context.

  1. Create the regulatory guideline. See Creating Regulatory Guidelines.
    This process also included uploading the file received from the regulatory authority.
  2. Add a regulatory context to the guideline. See Regulatory Contexts List.
  3. Promote the regulatory guideline to Active.

Define a Regulatory Company Calendar

Company calendars take holidays into consideration when calculating estimated dates for the schedule and timeline. For these calculations, company calendars consider weekends as holidays and calculate days based on actual work days. However, regulatory calendars must use calendar days, and not work days. Regulatory Administrators must create a regulatory company calendar to use in place of any other company calendars (which likely are used for other projects).

To define a company calendar for calendar days (instead of work days), the regulatory company calendar contains a single event in the past (or in the far future). That date must always be outside of the time period of the regulatory submission process so that all estimated dates are based on calendar day counts (because there are no weekends or holidays defined).

  1. Create a regulatory company calendar.
    1. With Collaboration and Approvals the active app, click View My Company.
    2. Click Calendar in the navigation pane.
    3. On the page toolbar or Actions menu, click Create New.
    4. Enter a Name and Description, and click Done.
    5. On the Events page tab, click Create New.
    6. Enter these details:

      Field nameDescription
      TitleEnter a title for the calendar, such as Regulatory Company Calendar.
      FrequencyMake sure Non-Recurrence is selected.
      Start DateSelect a date in the past or far future. For example, select January 1 of the current year.
      End DateSelect the same date.
      NoteEnter any information to describe the purpose of this calendar, such as "Calendar for regulatory submission projects."

    7. Click Done.
  2. Edit the Regulatory.RegulatoryCalendar.DefaultCompanyCalendarName property in Regulatory.properties file. Use the title you defined here as the value for that property. See Properties for Submissions.

This calendar is used for the Regulatory Calendar phase, Interactive Review phase, or Regulatory Milestone for a submission project.

Create Regulatory Calendar Templates

The phases, tasks, and milestones (and the durations) are determined based on the regulatory context and typically defined in the regulatory guidelines. Regulatory Administrators can create a regulatory calendar template for each regulatory context so that Regulatory Leads can simply add that calendar to the schedule for a submission project without needing to find the information and manually enter it.

  1. Create the regulatory calendar template. See Creating Regulatory Calendar Templates.

    The template includes a regulatory calendar phase and regulatory milestones for clock start (when the regulatory authority starts processing the submission) and market authorization (when you receive the authorization number and documents).

  2. Add regulatory contexts. See Regulatory Contexts List.
  3. Add regulatory guidelines. See Regulatory Guidelines List.

    You can only add regulatory guidelines associated with regulatory contexts already added to the template. If you have not added any regulatory contexts yet, no guidelines show in the search results.

  4. Add additional regulatory milestones to the regulatory calendar phase as defined by the regulatory guidelines for the specific regulatory context.

    You can add regulatory milestones with these purposes:

    • Question
    • Response
    • Assessment Report
    • Oral Explanation
    • Procedure Go

  5. Define local and escalation calendars. See Schedule Page for a Regulatory Calendar Template.

    Local calendars are defined for each country included in a regulatory context. Escalation calendars are defined in the regulatory guidelines.

    To define a local calendar, add a Regulatory Calendar to the schedule and set the Scope to Local.

    To define an escalation calendar for the global scope, add a Regulatory Calendar to the schedule and set the Scope to Global and the Esc. Level to 1 (for the first escalation calendar).

    Add as many local and escalation calendars that could be required for the regulatory context. When this calendar template is used, the Regulatory Lead can remove any items from the schedule that do not apply to that specific submission project.

  6. Promote to the Active state. The regulatory calendar template must be approved by a Regulatory Administrator before it can be promoted to active.