PMDA E2B Downgrade report does not schedule (Doc ID 2171030.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

The PMDA E2B report has been submitted with the Japan license.

By the follow-up information, this license has been removed from the case.

As of now, the different Japan license exists and only non-reportable event has been set in the case.

When auto-scheduling the report, the nullification report was scheduled. It supposed to schedule the downgrade report instead of the nullification report.

Conditions:

"Allow multiple reports for Marketed/Investigational Drugs" is unchecked for agency in the codelist: reporting destination > EDI tab

Steps to replicate:

Scenario#1: Delete the license

1. The initial PMDA E2B report for Japan license(A) has been auto-scheduled. (Because the conditions of the reporting rule is matched with current case data)
2. Transmit and submit the initial report
3. Receive ACK

4. Unlock the case as a significant info
5. Go to the product tab, delete the product/license for Japan license(A)
6. In the product tab, the product/license for Japan license(B) exists
7. In the event tab, non-reportable event for Japan license(B) exists
8. Go to the regulatory report tab
9. Press the [Auto schedule] button

 The nullification report was scheduled to the Japan license(A) which already deleted from the case.
(There is no reporting rules that is matched with current case data.)

 Scenario#2: Change the study product

Study(A) has two company products, product(A)and product(B).
- Product(A) has Japan marketed license(A).
- Product(B) has Japan marketed license(B)

1. In the clinical trial case, the study(A) has been selected
2. In the product tab, product(A) has been selected as "study drug"
3. The initial report for Japan license(A) has been auto-scheduled (Because the conditions of the reporting rule is matched with current case data)
4. Transmit and submit the initial report
5. Receive ACK

6. Unlock the case as a significant info
7. In the product tab, change the study drug to "product(B)"
8. In the event tab, non-reportable event for Japan license(B) exists
9. Go to the regulatory report tab
10. Press the [Auto schedule] button

The nullification report was scheduled to the Japan license(A) which already deleted from the case.
(There is no reporting rules that is matched with current case data.)

Changes

Cause

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