Regulatory Guideline Lifecycle

Regulatory guidelines define the process for submission based on the regulatory context (submission type, regulatory category, and regulatory authority). Each regulatory authority defines its own guidelines that must be followed when submitting a market authorization request to that authority.

The regulatory guideline lifecycle includes these states:

This page discusses:

Inactive

The Regulatory Administrator creates the regulatory guideline in the Inactive state. 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.

After creation, the Regulatory Administrator adds a regulatory context including the regulatory activity. The regulatory activity determines what type of authorization is being requested: Intitial Submission, Renewal, and so on. When the regulatory guideline is ready for use, the Regulatory Administrator promotes it to the Active state.

Active

In the Active state, the regulatory guideline can be used as a reference in submissions, submission templates, or regulatory calendar templates. No one can make any changes to an active regulatory guideline.

The Regulatory Administrator cannot demote the regulatory guideline if an active regulatory calendar template or submission template uses it, or if a submission project that has not yet been completed uses it.

Obsolete

Regulatory authorities update their guidelines for various reasons. When a new guideline is received, the Regulatory Administrator promotes the superseded guideline to Obsolete. That regulatory guideline is no longer valid as a reference for defining submissions.

When a regulatory guideline is in the Obsolete state, it cannot be demoted to either the Active or Inactive state. No one can make any changes to a regulatory guideline once it is in the Obsolete state.