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: