Regulatory Authorities List

Regulatory authorities are the government agencies that regulate pharmaceuticals and medical devices. Regulatory authorities provide details about submission types, regulatory categories, and regulatory guidelines that you use to configure Market Registration and Device Identification.

Required access roles: Regulatory Administrator or regulatory authority owner

To access the list of all regulatory authorities:

  1. Click Home .
  2. In the navigation pane, click Regulatory Context Definition.
  3. Click the Regulatory Authorities page tab.

To access this list from the home page:

  1. View the Market Registration home page.
  2. Click the Regulatory Context Definition page tab.
  3. Click the Regulatory Authorities subtab.

To access this page as a category for another item:

  1. Open the required submission type or regulatory category.
  2. Click the Regulatory Authorities page tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Name The automatically-generated name of the regulatory authority. Click to view the Properties page. See Regulatory Authority Properties.
Title The descriptive name of the regulatory authority.
Drop Adds a submission type and regulatory category using the drag-drop option.
Note: You can drag and drop a submission type and regulatory category to a regulatory authority, if the selected submission type and regulatory category are in the Active state and the regulatory authority is in the Inactive state.
Type The object type: Regulatory Authority.
State The current lifecycle state.
Region The regions that include any countries associated with this regulatory authority.
Country The countries in which this authority operates, and any other countries that accept market authorizations from this agency.
Language(s) The languages used in the listed countries.
Country Stability A description of the stability of the government for the listed countries.
Description Additional details about this authority.

Actions/Toolbar Commands

This table lists actions available on the list of all Regulatory Authorities and the Regulatory Authorities page tab in the Regulatory Context Definition page.

Action Name Description For More Information
Create Regulatory Authority Creates a new regulatory authority.

Required access role: Regulatory Administrator

Creating a Regulatory Authority
Delete Selected Deletes the selected regulatory authority. Click OK to confirm. The regulatory authority must be in the Inactive state to delete it.

Required access role: Regulatory Administrator

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Enable Edit Toggles the page into the edit mode. In edit mode, you can edit the details for an Inactive regulatory authority.

Required access role: Regulatory Administrator or regulatory authority owner

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Disable Edit Toggles the page into the view mode.

Required access role: Regulatory Administrator or regulatory authority owner

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For the Regulatory Authorities page tab for a submission type or regulatory category, you do not have any actions available. If you want to associate a regulatory authority with a submission type or regulatory category, access the regulatory authority, then use the Add Existing command on its Submission Type or Regulatory Categories page. See Submission Types List or Regulatory Categories List.