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.
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).
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.
- 再審査期間中（要指導）which is E2B code (6)
- PMS 期間中（要指導）which is E2B code (7)
When the value for E2B code 1,2 or 5 is selected, this error does not occur.
Steps:
- Create new case with Japan license
- Go to Analysis > PMDA info tab
- 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
- Enter the mandatory information for PMDA E2B (R3)
- Save the case
- In the regulatory report tab, schedule PMDA E2B (R3) to this Japan license
- Click the draft link to view the report
- PMDA Validation errors displays for J2.4.k - MHLWSTATUSCATEGORYOFNEWDRUGS
Changes
Cause
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In this Document
| Symptoms |
| Changes |
| Cause |
| Solution |