Search for and add external product codes from the Japan Drug Dictionary (JDD).
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About the Japan Drug Dictionary (JDD)
Vault Safety supports the PMDA-compliant Japan Drug Dictionary (JDD) for Domestic and Localized Case processing for Japan. You can add JDrug codes to External Products.
When you add a JDrug code to an External Product, if the Japan Product Code Type is J-Drug Code, Vault maps the first seven (7) digits of the Local MPID to the G.k.2.3.r.1 Substance / Specified Substance Name data element of PMDA E2B(R3) reports.
For information on processing Cases that may be reportable to the PMDA, see Complete Intake and Process Cases for the PMDA.
Prerequisite
Consider the following prerequisites for coding from the JDD:
- Your Admin must complete the required configuration.
- Your Admin must enable PMDA E2B(R3): Export Substance Codes from JDrug Codes.
- Your organization must maintain a valid JDD license to use the centralized JDD service.
Browse and Code JDrug Products
In the Case Products section of a Domestic Case for Japan, you can search the JDD to add an External Product:
- In the Case Products section, access the Product Browser. In the top-right corner of the dialog, select Launch JDrug to launch the JDrug Browser.
- If you populated the reported Product or Country Obtained field, search results are filtered to those values. The reported Product English term appears below the Search bar.
- Optionally, you can select Back to Product Browser in the top-left corner of the browser to return to the Product Browser to code a Company Product.
- In the Search bar, enter or change the search terms, and then select Search. Vault checks the terms against the JDrug codes, Drug Names, and Generic Drug Names.
When entering a combination of numeric and alphabetic characters to search for a JDrug code, you must enter a space before and after the alphabetic character. For example, to find JDrug code “1234A123”, enter your search term as “1234 A 123”. - To apply a JDrug code, select the code and then select Confirm.
- Select Save.
Result
The JDrug control field appears on the Create Case Product page. Vault adds the selected JDrug code, the manufacturer, and the Local MPID details to the field and sets the Japan Product Code Type field to “J-Drug Code”. To remove a JDrug code and its related details, select Clear Selection.
On Localized Product records, field values are updated as follows:
- The JDrug code appears in the Product (Coded) field.
- The manufacturer appears in the Registration Holder/Applicant field.
- The Local MPID from the selected JDrug code appears in the Local MPID field.
- “J-Drug Code” appears in the Japan Product Code Type field.
Note: For some Over-the-Counter Drug reporting scenarios, only the Local MPID is required. You can enter the JDrug code directly into the Local MPID field. To export the first seven (7) digits of the Local MPID to the G.k.2.3.r.1 Substance / Specified Substance Name data element of PMDA E2B(R3) reports, you must also set the Japan Product Code Type field to J-Drug Code.
JDrug Browser Columns
The following table describes the JDrug Browser columns.
| Column | Description |
|---|---|
| Drug Code | The JDrug code for the External Product. |
| Drug Name | The brand name under which the product is sold. |
| Generic Drug Name | The generic name for the External Product. |
| Manufacturer Name | The name of the manufacturer of the External Product. |
| Manufacturer Code | The code for the manufacturer of the External Product. |