The browser-based Publish now allows users to define their keywords as per their specific requirement of Code and Code systems for eCTD 4.0 under Context Groups.
All Context Groups that are user defined (have both dropdowns as well as free text options) such as in M3 (3.2.S, 3.2.P), M4 (4.2.1, 4.2.2, 4.2.3) and M5 (5.3), are now provisioned with two additional fields 'Code' and 'Code System' allowing users to enter the details as per their requirement.
These two fields which were previously only auto-generated, can now be filled with details as per the user's choice.
If left blank, these fields will still be auto-generated.
Purpose of these fields:
Specific clients working on eCTD 4.0 applications (such as Japan) had requirements for these code and code system to be user defined for every keyword instead of auto-generated ones and thus, the provision has been made for the same.