Receive Negative ACK for a PMDA R2 Nullification Report After a Downgrade Report in Argus Safety Japan 7.x and 8.x

(Doc ID 2321496.1)

Last updated on OCTOBER 26, 2017

Applies to:

Oracle Argus Safety Japan - Version 7.0.0 and later
Information in this document applies to any platform.

Symptoms

A previously submitted case was downgraded due to its seriousness (all events were non-serious) and there were no more reportable events in the case.  In the PMDA R2 downgrade report, data element J.8 (Category of the new drug) = 5.

The Marketing Authorization Holder (MAH) received follow-up information that the patient did not take a company drug and then the MAH sent a PMDA R2 nullification report.  In this nullification report, data element J.8 = 5.

The Pharmaceuticals and Medical Devices Agency (PMDA) sent a negative ACK back to the MAH because of J.8 = 5.

Cause

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