4 Configure the Routes of Administration flexible re-categorization codelists (NMPA Only)

The flexible re-categorization codelist is enhanced to include the new attribute cn to store Chinese terms for Routes of Administration and Dose Formulation. Chinese terms are provided only for the standard list of RoA and DF terms published by NMPA as part of the release. Make sure to add Chinese text for all the remaining terms for Routes of Administration and Dose Formulation. This is sent as free text in the E2B(R3) report for NMPA, if the term is not part of the standard term list.

Follow these steps to configure the Routes of Administration flexible re-categorization code lists:

1. Click Code lists, then click Flexible Data re-categorization.
2. On the Flexible re-categorization folder, select ROUTE from the Code List Name drop down.
3. Click Search. Note the cn column in the ROUTE table.
   
4. Add Chinese text for non-standard terms, if it applies.
5. Save the changes.

   Note:

   The flexible re-categorization codelist does not validate the cn attribute. You are required to enter the information to limit the number of characters as per the ICH recommendation.