To add a new sequence, begin by opening Publish and choose New > Sequence from the Manage menu (make sure you are not in Sequence view). Adding sequence information in the Add Sequence dialog is the same as described in the “Create a New Application” section. However, you may need to set a Related Sequence for your new sequence, if it is being added to an existing Regulatory Activity.
Below is best practice for Related Sequences, based on region:
United States/ FDA –
Always choose a related sequence number for Amendments and Resubmissions. This will allow them to be grouped with top-level application types such as original applications and supplements in order to form regulatory activities. Related sequence numbers cannot be entered for any other submission types. –
Normally, a sequence is only related to a single regulatory activity. There are rare exceptions (for example, an amendment that applies to two supplements).
European Union/ EMA
Always choose a related sequence for Supplemental Information or Correction to the Published Annexes sequences. This will allow them to be grouped with top-level application types in order to form regulatory activities.
Related sequences should not be selected for any other submission types.
It is possible for a sequence to relate to more than one.
Canada/ Health Canada
Always choose a related sequence number when a new sequence is part of an existing regulatory activity. This will allow all of the sequences in the regulatory activity to be grouped. Manage a Sequence 93
All sequences in the same regulatory activity should have the same sequence type.
A sequence can only be related to a single sequence in Canada
that is, a sequence cannot be part of more than one regulatory activity.
Australia/ TGA
Always choose a related sequence number when a new sequence is part of an existing regulatory activity. This will allow all of the sequences in the regulatory activity to be grouped.
All sequences in the same regulatory activity should have the same sequence type.
A sequence can be part of more than one regulatory activity, however it is not advised and will show as a technical error.
Switzerland/ Swissmedic
Always choose a related sequence for Supplemental Information or Correction to the Published Annexes sequences. This will allow them to be grouped with top-level application types in order to form regulatory activities.
Related sequences should not be selected for any other submission types.
It is possible for a sequence to relate to more than one Regulatory Activity