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PMDA E2B (R3) J2.1b Validation Error Appears On Follow-up Report (Doc ID 2721420.1)

Last updated on OCTOBER 20, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.2.1 and later
Information in this document applies to any platform.


The following PMDA ICSR validation error appears when viewing the PMDA E2B (R3) follow-up report (such as regular follow-up, downgrade, or nullification).


PMDA ICSR Validation
Other validation : J2.1b - MHLWADMICSRCASENUMB

For Follow-up Reports the values of following elements should match with the corresponding elements in the  Previous ・Report classification (J2.1a) ・Identification number (J2.1b) ・Message sender identifier (N.2.r.2) ・Worldwide unique case identifier (C.1.8.1).


1. Transmit PMDA E2B
2. Receive error ACK
3. In the regulatory report tab > view report details, set the report status as "No Submission Required"

4. Fix the case data
5. Save and lock the case
6. Schedule PMDA E2B again
7. Generate the final report
8. Transmit PMDA E2B again
9. Receive normal ACK with ACK number

10. Open the case and go to analysis > PMDA info
11. Confirm that ACK number (which is value of J2.1b) is populated after importing normal ACK

Unlock the case as significant info
13. Update the case data
14. Schedule the follow-up report (such as regular follow-up, downgrade or nullification)
15. View the report

PMDA ICSR Validation for J2.1b appears.




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