Creating Regulatory Calendar Templates

You can create regulatory calendar templates that can be used with submission projects.

Required access role: Regulatory Administrator

  1. Do one of the following:
    1. From the top bar, click Add > Market Registration > Create Regulatory Calendar Template.
    2. Open the list of all regulatory calendar templates, then from the page toolbar or Actions menu, click Create . See Regulatory Calendar Templates Page.
  2. Enter these details:

    Field NameDescription
    TitleEnter a descriptive name for the regulatory calendar template.
    DescriptionProvide descriptive information about the purpose and use of this regulatory calendar template.

  3. Click Done.

The app creates the template in the Inactive state and assigns a name using this format: RCT- followed by the next sequential number. The template includes:

  • A single regulatory calendar phase with regulatory milestones that have these regulatory purposes defined:
    • Clock start
    • Market authorization
  • Scope is set to Global, Escalation level is set to 0
  • Finish-to-Start dependency with +1 day lag

To complete defining the regulatory calendar template:

  • Add additional regulatory milestones to the schedule. Required access role: Regulatory calendar template owner.
  • Add regulatory contexts. Required access roles: Regulatory Administrator or regulatory calendar template owner.
  • Add regulatory guidelines. You can only add regulatory guidelines associated with regulatory contexts already added to the regulatory calendar template. Required access roles: Regulatory Administrator, Regulatory Lead, Regulatory User, or regulatory calendar template owner.
  • Add bookmarks.
  • Promote to the Active state. Required access roles: Regulatory Administrator or regulatory calendar template owner.