Regulatory Guidelines List

Regulatory guidelines define the process for submission based on the regulatory context (submission type, regulatory category, and regulatory authority).

You can add the regulatory guidelines to a submission template for the regulatory context covered by those guidelines. Then, when a regulatory context for that context is created from the submission template, the appropriate guidelines are attached to the submission project itself.

Required access roles: Regulatory Administrator, Regulatory Lead, Regulatory User, or regulatory guideline owner

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access the list of all regulatory guidelines:

  1. Click Home .
  2. In the navigation pane, click Regulatory Guidelines.

To view the guidelines for a submission project:

  1. Open the required submission. See Opening a Submission.
  2. In the navigation pane, click Regulatory Information.
  3. Click the Regulatory Guidelines page tab.

To view the guidelines for a template:

  1. Open the required submission template or regulatory context template. See Opening a Submission Template or Opening a Regulatory Calendar Template.
  2. Click the Regulatory Guidelines page tab.

This topic describes:

This page discusses:

See Also
Opening a Regulatory Guideline
Regulatory Guideline Properties

Columns

Column NameDescription
NameThe auto-generated name of the regulatory guideline.
TitleA descriptive name for the regulatory guideline.
TypeThe item type: Regulatory Guideline.
Category The category for the regulatory guideline.
StateThe current lifecycle state: Inactive or Active.
RevThe revision level of the regulatory guideline.
VerThe version level of the regulatory guideline.
Number of files locked / number of files checked into this document. For example, 2/4 indicates 2 files of the 4 files checked into this object are locked.
Actions

Icon Name Action


Subscribe

View and select subscriptions for a document.



Download

Download the files in the regulatory guideline to your local computer. Navigate to the folder or directory you want to contain the file.

When the document contains multiple files they are downloaded in a single zip file.



Check Out and Lock

Check out the files in the regulatory guideline to your local computer and lock the files from other users who cannot unlock it. Navigate to the folder or directory you want to contain the file.

When the document contains multiple files they are downloaded in a single zip file.

Required access role: Regulatory Administrator or regulatory guideline owner


Update Files

Update a checked-out file to its next version.

Required access role: Regulatory Administrator or regulatory guideline owner


Check In

Check in a new file.

Required access role: Regulatory Administrator or regulatory guideline owner


Lock

Lock the file without checking it out.


Unlock

Unlock the file without checking in a new version.

OwnerThe person responsible for the regulatory guideline. Click to view the Properties page for the person.
Responsible OrganizationThe company responsible for maintaining the regulatory guidelines.
DescriptionDescriptive text about the regulatory guideline.
File Drop Provides option to drag and drop the selected file for the regulatory guideline. You can drag a file and drop it to icon to add the selected file.
ModifiedThe most recent date that changes were made to the regulatory guideline.
Opens the regulatory guideline in a new window.

Actions/Toolbar Commands

Required access role: Regulatory Administrator

Action NameDescriptionFor More Information
Create New Regulatory Guideline Creates a regulatory guideline. In this case, "creating" means obtaining the document from the regulatory authority and uploading it to Market Registration. The regulatory guideline item holds the document provided by the regulatory authority. Creating Regulatory Guidelines
Delete Selected Deletes the selected regulatory guidelines. Click OK to confirm.

You can only delete regulatory guidelines in the Inactive state, and only if the guideline is not used in a submission template.

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These actions show on the category page for another item (submission, submission template, or regulatory calendar template).

Action NameDescriptionFor More Information
Add Existing Adds active regulatory guidelines to the list. You can only add a regulatory guideline to an inactive submission template, to a regulatory calendar template, or to a submission that has not yet been completed.

Required access role: Regulatory Administrator

Submission templates: If a regulatory context is defined, you can only add regulatory guidelines that are already associated with that regulatory context.

Regulatory calendar templates: You need to add regulatory contexts to the template first. Then, you can add any regulatory guideline associated with any of those contexts.

Submission projects:

  • If a submission is beyond the Preliminary state, but not yet complete, you must justify why you are adding the regulatory guideline.
  • The search only includes regulatory guidelines associated with the regulatory context defined for the submission, and also takes the regulatory activity category and subcategory into account.
About Searches
Remove Selected Removes the selected regulatory guidelines from the list. Click OK to confirm.

Required access role: Regulatory Lead

From a submission template, you can only remove inactive regulatory guidelines.

From a submission, you can only remove regulatory guidelines if the submission is not yet complete. If the submission is beyond the Preliminary state, you must justify why you are removing the regulatory guideline.

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