Regulatory Categories List

Regulatory categories define how a regulatory agency classifies a product for evaluation. For example, a medicinal product could be considered a drug in one country and a food supplement in another.

Required access role: Regulatory User

To access the list of all regulatory categories:

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

To access this page for a regulatory authority:

  1. Open the required regulatory authority.
  2. Select the Regulatory Categories page tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Name The automatically-generated name of the regulatory category.
Title The descriptive name of the regulatory category.
Drag Adds the selected regulatory category to a regulatory authority. You can use the icon to drop the regulatory category and to drop it in a regulatory authority.
Note: You can drag and drop a regulatory category to a regulatory authority, if the selected regulatory category is in the Active state and the regulatory authority is in the Inactive state.
Type The item type: Regulatory Category.
State The current lifecycle state of the regulatory category:
  • Active
  • Inactive
Regulatory Authorities The regulatory authorities that recognize this regulatory category for submissions. Click to view the Properties page for a regulatory authority.

This list only shows Active authorities. If an inactive authority uses this category, that authority does NOT show in this list.

Description Descriptive text about the category.

Actions/Toolbar Commands

Only Regulatory Administrators can access these actions. This table lists actions available on the Regulatory Categories page tab on the Regulatory Context Definition page.

Action Name Description For More Information
Creates a regulatory category.

Required access role: Regulatory Administrator

Creating a Regulatory Category
Delete Selected Deletes the selected regulatory categories. Click OK to confirm.

You can only delete inactive regulatory categories.

Required access role: Regulatory Administrator or regulatory category owner

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Enable Edit Toggles the page into edit mode. In edit mode, you can change the state and edit the description.

You cannot edit the regulatory authority field. To associate a regulatory authority with a regulatory category, use the Regulatory Categories page tab for the regulatory authority.

Required access role: Regulatory Administrator or regulatory category owner

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Disable Edit Toggles the page into view mode.

Required access role: Regulatory Administrator or regulatory category owner

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This table lists actions available on the Regulatory Categories page tab for a regulatory authority. You can only add regulatory categories to or remove regulatory categories from a regulatory authority in the Inactive state.

Action Name Description For More Information
Add Existing Searches for and selects regulatory categories to add to this list.

Required access role: Regulatory Administrator or regulatory authority owner

About Searches
Remove Selected Removes the selected regulatory categories. Click OK to confirm.

You can only remove inactive regulatory categories.

Required access role: Regulatory Administrator or regulatory authority owner

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