PMDA E2B (R3) ICSR Validation Error for J2.4K <MHLWSTATUSCATEGORYOFNEWDRUGS>
(Doc ID 2427861.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety Japan - Version 8.1 to 8.2 [Release 8.1 to 8.2]Information in this document applies to any platform.
Goal
The following two issues have been reported and are currently outstanding bugs:
- Bug 27320614 - J2.4.k Error At INV ICSR For PMDA On Foreign Non-blinded Case
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.
- Bug 27412173 - J2.4.k Error At MKT / INV ICSR For PMDA On Domestic Blinded Case
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 |