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Withdrawn: The request to review has been withdrawn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.
Current RA State | Available Next States | Notes |
Pending | Under Review | System generated change occurring when any sequence in this RA changes to an In-Progress state. It is not available to the user. |
Under Review | Pending | System generated change occurring when all sequences in this RA are in an In-Progress or Submission ready state |
| Hold |
|
| Approved | Only available if all sequences in the Regulatory Activity are Submitted. When parent RA is in the Approved state, all Submitted sequences change to ‘Activity approved’ state in the interface |
| Withdrawn | Only available if all sequences in the Regulatory Activity are Submitted.
When the parent RA is in the Withdrawn state, all Submitted sequences, their sections, and file references change to ‘Activity withdrawn’ state in the interface.
No sequences can be added to a Withdrawn Regulatory Activity.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 interface. |
Hold | Under Review |
|
| Withdrawn | Only available if all sequences in the Regulatory Activity are Submitted.
When parent RA is in the Withdrawn state, all Submitted sequences, their sections, and file references change to Activity withdrawn state in the interface.
Sequences can no longer be added to a Withdrawn Regulatory Activity. |
Withdrawn | Under Review |
|
| Hold |
|