Characterizing Fit-for-Purpose Real-World Data: An Assessment of a Mother-Infant Linkage in the Japan Medical Data Center Claims Database.

The JMDC may be well suited for descriptive studies of pregnant people in Japan (eg, comorbidities, medication usage). More work is needed to identify a method to assign pregnancy onset and delivery dates so that in utero medication exposure windows can be defined more precisely as needed for many regulatory postapproval pregnancy safety studies.