Regulatory Authority Lifecycle

A regulatory authority represent a specific agency that has authority to grant market authorization for a product. For example, the Federal Drug Administration (FDA) is the regulatory authority for the United States.

The regulatory authority lifecycle includes these states:

Note: Regulatory authorities created prior to 3DEXPERIENCER2014xAD had a single state: Exists. Those regulatory authorities will be Inactive after installing a new software version.

This page discusses:

Inactive

The regulatory authority is created in this state. Before promoting to active, a Regulatory Administrator must:

  • Add submission types
  • Add regulatory categories
  • Add countries

Active

The Regulatory Administrator can promote the regulatory authority to Active once it is configured. The regulatory authority cannot be demoted to the Inactive state if it is used by any regulatory context.