11 E2B(R3) elements with data in Chinese
NMPA mandates to transmit data for certain elements in Chinese. Argus supports multi-language data entry as required by NMPA.
The following fields are enhanced in Argus 8.2.3.1 to support multi-language data entries:
- Case Form > General tab > Reporter Information section > Institution
- Case Form > Patient or Parent tab > Pregnancy Information section > Delivery Notes
- Case Form > Products tab > Product Information section > Product Name
- Case Form > Product > Product Information > Generic Name
The below code list is enhanced to add the Chinese name for the manufacturer list. The Chinese name should be configured because it is required to transmit the DRUGAUTHORIZATIONHOLDER [G.k.3.3]:
- Argus Console > Code Lists > Flexible Data Re-Categorization > Flexible Re-Categorization folder > MANUFACTURER Code List Name
Note:
For all other elements that need Chinese data, Argus already supports multi-language data entry. The NMPA E2B(R3) mappings are updated to use Chinese data to transmit the elements. For more details, refer to the E2B(R3) mapping document.The following table describes the list of elements with mandatory Chinese data:
| # | Element description | Element conformance | Type of case |
|---|---|---|---|
| 1 | Name of Medical Institution/Distributor (D.CN.3) | Optional | All cases |
| 2 | Pregnancy Description (D.CN.6) | Optional | All cases |
| 3 | Autopsy-determined Cause(s) of Death (free text) (D.9.4.r.2) | Conditional Mandatory | Domestic cases (Post marketed and Clinical trial) |
| 4 | Generic name of the drug (G.k.CN.1) | Conditional Mandatory | Domestic cases (Post marketed and Clinical
trial)
Foreign cases (Clinical trial) |
| 5 | Related device (G.k.CN.2) | Optional | All cases |
| 6 | Medicinal Product Name (G.k.2.2) | Mandatory | Domestic cases (Post marketed)
Foreign cases (Post marketed) |
| 7 | Name of holder/applicant (G.k.3.3) | Optional | All cases (The name of the company registered with NMPA. It may be all English characters if registered likewise) |
| 8 | Pharmaceutical form (G.k.4.r.9.1) | Optional | All cases |
| 9 | Route of Administration (G.k.4.r.10.1) | Optional | All cases |
| 10 | Parent Route of Administration (G.k.4.r.11.1) | Optional | All cases |
| 11 | Case Narrative (H.1) | Mandatory | Domestic cases (Post marketed and Clinical trial) |
| 12 | Reporter Comments (H.2) | Optional | Domestic cases (Post marketed and Clinical trial) |
| 13 | Sender Comments (H.4) | Optional | Domestic cases (Post marketed and Clinical trial) |