My Oracle Support Banner

PMDA E2B G.k.3.2 <drugauthorizationcountry> Displays for Unapproved Investigational License (Doc ID 2733396.1)

Last updated on DECEMBER 07, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.2 and later
Information in this document applies to any platform.

Symptoms

Issue:

The case has a Japan Investigational License and PMDA E2B (R3) has been scheduled to this investigational license.

When view PMDA E2B from this case, the drug authorization country which is G.k.3.2 <drugauthorizationcountry> populates.

<drugauthorizationcountry>JP</drugauthorizationcountry>

G.k.3.2 <drugauthorizationcountry> should not populate in PMDA E2B because this investigational license has not been approved in Japan yet.

 

Steps:

1. Create a new case with the product which has the Japan Investigational license

2. Go to Analysis > PMDA info tab

3. Confirm that Japan Investigational license is populated

4. Set the J2.4.k "Status category of new drugs" as "Unapproved (未承認)" against Japan Investigational license

5. Enter the mandatory value for PMDA E2B (R3)

6. In the regulatory report tab, schedule PMDA E2B (R3) with Japan Investigational license

7. Save the case

8. Click the draft link

For example:

<drug>
     <druguniversallyuniqueid>0e1e1a11-1e0d-11d0-1111-df116ad11</druguniversallyuniqueid>
     <drugcharacterization>1</drugcharacterization>
     <mhlwstatuscategoryofnewdrugs>3</mhlwstatuscategoryofnewdrugs>
     <medicinalproduct>CCN123</medicinalproduct>
     <obtaindrugcountry>JP</obtaindrugcountry>
     <invproductblinded>true</invproductblinded>
     <drugauthorizationcountry>JP</drugauthorizationcountry>

J2.4.k <mhlwstatuscategoryofnewdrugs> shows as 3 which means this is the "Unapproved" investigational license.
However, G.k.3.2 <drugauthorizationcountry> is popualted with the value "JP" even though this license has yet to be approved in Japan.

Cause

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


In this Document
Symptoms
Cause
Solution
References

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