Regulatory_Activity

Regulatory activities can have the following states:

• Pending: No sequences have been submitted.

• Submitted: At least one sequence in this activity has been sent to a regulator. However, some sequences may still be In Progress.

• Under Review: The regulator is reviewing the product.

• Hold: The regulatory review process is on hold.

• Approved: The regulator has approved the product.

• Withdrawn: The request to review has been withdrawn.

To change the regulatory activity state, click on the regulatory in the Regulatory Activity view and change the Regulatory Activity state in the State dropdown in the Details grid.

Regulatory Activity State Transitions
Current RA State	Available Next States	Notes
Pending	Under Review	This is a system generated change that occurs when any sequence in this RA changes to an In-Progress state. It is not available to the user.
Under Review	Pending	This is a system generated change that occurs when all sequences in this RA are in an In-Progress or Submission ready state.
	Hold
	Approved	This state is only available if all sequences in the Regulatory Activity are Submitted. The state of all Submitted sequences changes to ‘Activity approved’ in the user interface when the parent RA is in the Approved state. Sequences can no longer be added to an Approved Regulatory Activity.
	Withdrawn	This state is only available if all sequences in the Regulatory Activity are Submitted. The state of all Submitted sequences, their sections, and file references changes to ‘Activity withdrawn’ in the user interface when the parent RA is in the Withdrawn state. Sequences can no longer be added to a Withdrawn Regulatory Activity.
Approved	Under Review	This transition should only happen if the RA was placed in the Approved state in error. Sequences in the RA will return to the Submitted state in the user interface.
Hold	Under Review
Hold	Withdrawn	This state is only available if all sequences in the Regulatory Activity are Submitted. The state of all Submitted sequences, their sections, and file references changes to Activity withdrawn in the user interface when the parent RA is in the Withdrawn state. Sequences can no longer be added to a Withdrawn Regulatory Activity.
Withdrawn	Under Review
Withdrawn	Hold