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

Last updated on JULY 13, 2023

Applies to:

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)

• Product name (A) with drug formulation : unknown

|--- Japan investigational license name (A)

• Product name (A) with drug formulation : injection

|--- 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

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.