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Japan Case Or Foreign Case For PMDA Submission (Doc ID 2434839.1)

Last updated on FEBRUARY 26, 2019

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.


Currently system is deciding Japan (domestic) case or non Japan (foreign) case based on COI ("Country" on Case Form >> General tab).
Therefore, even if JP license is used but the event is occurred in foreign country, the case is considered as non-JP case and the correct 'Reporting Category' cannot be selected on the PMDA general tab.

This means we cannot submit the report with the correct 'Reporting Category'.

According to the PMDA QA for R3 (QA#77), JP case or non-JP case should be determined based on the license of the primary company suspect drug.
If JP license is used, the case should be considered as JP case, and non-JP license is used, the case should be considered as non-JP case.






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