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PMDA E2B (R2) J2.1b Validation Error Appears On Amendment Report (Doc ID 2817067.1)

Last updated on OCTOBER 26, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.2.3 and later
Information in this document applies to any platform.

Symptoms

Initial PMDA E2B (R2) has been submitted.

The case received the follow-up information and drug formulation of the suspect product was changed to the other drug formulation.

When viewing the amendment report, the following ICSR validation error appears.

 

Error:

PMDA ICSR validation
Mandatory : J2.1b - MHLWADMICSRCASENUMB

 

Steps:

The following product and license information is configured in Argus Console > Business configuration > Products and license

(for example)

|--- Japan investigational license name (A)

|--- Japan investigational license name (A)

 

  1. Create a new case
  2. Go to the product tab
  3. In the product tab, select the license of the product name (A) with formulation : unknown
  4. Set the mandatory information for PMDA E2B (R2)
  5. Save the case
  6. In the regulatory report tab,
    schedule initial PMDA E2B against the Japan INV license for the product name (A) with  formulation : unknown
  7. Lock the case
  8. Generate final report
  9. Transmit and submit the report
  10. Receive normal ACK with ACK number which is J2.1b
  11. Unlock the case as significant info / follow-up received date / amendment flag
  12. Go to the product tab
  13. Press the [Select] button
  14. Search the license of the product name (A) with formulation : injection
  15. Press the [Select] button
  16. Confirm that the drug formulation was changed to "Injection" from "unknown"
  17. Save the case

  18. Go to the regulatory report tab
  19. Schedule the amendment report against the Japan INV license for the product name (A) with formulation : injection
  20. Save the case
  21. Click the draft link of the amendment report
  22. ICSR validation (Mandatory for J2.1b) appears

 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References

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