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PMDA ICSR Validation Errors For J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS (Doc ID 2882236.1)

Last updated on JULY 13, 2023

Applies to:

Oracle Life Sciences Argus Safety Japan - Version 8.2.2 to 8.2.3.1 [Release 8.2]
Information in this document applies to any platform.

Symptoms

In the Analysis > PMDA info tab, license category "再審査期間中(要指導" or "PMS 期間中(要指導)" is configured to the Japan license.

When viewing PMDA E2B (R3) for this license, the following 2 validation errors display.

Mandatory:

ICSR Element                                                          Error Description
-------------------------------------                                 --------------------------------------------------------
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS        Value for J2.4.k[MHLWSTATUSCATEGORYOFNEWDRUGS] must exist for primary product.
Other Fatal Validation:

ICSR Element                                                          Error Description
-------------------------------------                                 --------------------------------------------------------
J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS        Value of J2.4K[MHLWSTATUSCATEGORYOFNEWDRUGS] shall belong to either 1,2,5,6 or 7 for Marketed Reports (Reporting category AA, AB, AC, AD, AE, AF, AG).


Note: This error only occurs when the following license categories are selected in the PMDA info tab.

When the value for E2B code 1,2 or 5 is selected, this error does not occur.
 

Steps:

  1. Create new case with Japan license
  2. Go to Analysis > PMDA info tab
  3. In the license category field, select the value "再審査期間中(要指導" or "PMS 期間中(要指導)" to Japan Marketed license
  4. Enter the mandatory information for PMDA E2B (R3)
  5. Save the case
  6. In the regulatory report tab, schedule PMDA E2B (R3) to this Japan license
  7. Click the draft link to view the report
  8. PMDA Validation errors displays for J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution


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