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PMDA E2B (R3) ICSR Validation Error for J2.4K <MHLWSTATUSCATEGORYOFNEWDRUGS> (Doc ID 2427861.1)

Last updated on NOVEMBER 05, 2018

Applies to:

Oracle Argus Safety Japan - Version 8.1 and later
Information in this document applies to any platform.

Goal

The following two issues have been reported and are currently outstanding bugs:

Problem Description
PMDA E2B R3 report generation fails with validation for J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] for Investigational Reports, even if the report is generated for an Marketed license.

 

Problem Description
PMDA E2B R3 report generation fails with validation for J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] for Marketed Reports, even if the report is generated for an Investigational license.

Solution

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In this Document
Goal
Solution
References

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