All drug dosage information for G.k.4.r.4 does not populate in PMDA E2B (R3)

(Doc ID 2344828.1)

Last updated on JANUARY 02, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.


According to the document "Oracle Argus Safety ICSR PMDA R3) Export Import Mapping Document Version 8.1.1",
when a case has REACTIONSTARTDATER3 (E.i.4) earlier than the first suspect drug’s DRUGSTARTDATER3 (G.k.4.r.4), then system does not transmit the first suspect drug’s DRUGSTARTDATER3 for PMDA E2B (R3).

However, this restriction does not exists in PMDA E2B (R3) regulation so all the dosage information should populate in G.k.4.r.x.




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