Opening a Regulatory Authority

You can access all the information related to a regulatory authority.

Required access roles:

  • Regulatory authority in the Inactive state: Regulatory Administrator or regulatory authority owner
  • Regulatory authority in the Active state: Regulatory Administrator, Regulatory Lead, Regulatory User, a submission lead or submission user who also has Regulatory Lead role, or regulatory authority owner

Before you begin: Market Registration should be the active app.
See Also
About Regulatory Context
  1. Click Home .
  2. In the navigation pane, click Regulatory Context Definition.
  3. Click the Regulatory Authorities page tab.
  4. Click the name of the regulatory authority.

    You can use the categories in the navigation pane to access information related to the regulatory authority.

    Category NamePage TabsDescriptionFor More Information
    Regulatory authority namePropertiesLists the properties for the regulatory authority.Regulatory Authority Properties
    Submission TypesLists the submission types associated with this regulatory authority.Submission Types List
    Regulatory CategoriesLists the regulatory categories associated with this regulatory authority.Regulatory Categories List
    CountriesThe specific country in which this authority operates, and any other countries that accept market authorizations from this agency.Countries Page
    LanguagesThe languages used in the region and country.Languages Page
    LifecycleShows the lifecycle for the regulatory authority with the current lifecycle highlighted in blue.

    You cannot change the state from Active to Inactive if the regulatory authority is in use.

    		3DEXPERIENCE Basics: Lifecycle Page
    HistoryProvide an audit trail for the regulatory authority.3DEXPERIENCE Basics: Viewing History for Content
    Reviewers-Lists the people at the authority who review submissions.Reviewers List
    Reference Documents-Lists documents related to the regulatory authority. Collaboration and Approvals User's Guide: Documents and Content