**Source URL:** https://safety.veevavault.help/en/lr/1026368/

# NMPA Localized Case Field Reference

To support safety reporting, _Localized Cases_ for China include unique regional fields. During report generation, Vault maps this region-specific data to NMPA E2B(R3) files. For information on non-regional fields, see Localized Case Field Reference.

While you can manually enter data into certain fields, Vault copies some information from the global _Case_. This mapping occurs:

* Upon _Localized Case_ creation
* When the _Resync Foreign Cases_ action runs
* During [China-specific data syncing][1]

To protect your data and ensure accuracy, Vault:

* Maps data only to blank fields, never overwriting an existing value.
* Maps these regional fields only when the _Localization_ on the domestic _Case_ or _Localized Case_ is _Chinese_.

## Field Mapping

The following sections outline NMPA-specific fields, identifying which are mapped by Vault and which require manual entry. For Vault-populated fields, fields remain empty if the criteria are not met. In addition, the tables identify each field's corresponding NMPA E2B(R3) data element.

### Details Section

The following _Details_ section fields may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_NMPA Report Classification_
            <td>Select the NMPA report classification type.
            <td>C.1.CN.2
        
        <tr>
            <td markdown="span">_NMPA Report Source_
            <td>Select the source of the report.
            <td>C.1.CN.1
        
        <tr>
            <td markdown="span">_Local New Info Date/Time_
            <td markdown="span">Enter the latest date additional information was received about the _Localized Case_. Use the calendar to select the date or enter the date manually.
            <td>C.1.5
        
        <tr>
            <td markdown="span">_Local MAH_
            <td markdown="block">Vault maps the _Official Name_ on the _Localized Organization_ related to the _Registrant Holder/Applicant_ on a _Product Registration_ for the NMPA using the following priority order:

1. If the product is a _Combination Product_ constituent, the earliest-created _Combination Product Registration_ of the _Combination Product_ on the suspect primary _Case Product_
2. The earliest-created _Product Registration_ of the suspect primary _Case Product_
3. The earliest-created _Product Registration_ of
    * The suspect _Case Product_ with the next highest _Rank_ that has a _Product Registration_ for the NMPA
    * The earliest created suspect _Case Product_ without a _Rank_
4. The earliest-created _Product Registration_ with a related _Localized Organization_ that includes an _Official Name_

            <td>C.1.CN.3

### Localized Case Contacts Section

The following _Localized Case Contact_ section fields may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_NMPA Report Source_
            <td markdown="span">For _Reporter_-type _Case Contacts_, select the source of the report.
            <td>C.1.CN.1
        
        <tr>
            <td markdown="span">_NMPA Patient Nationality_
            <td markdown="span">For _Patient_-type _Case Contacts_, enter the 2-letter Chinese nationality code.
            <td>D.CN.1
        
        <tr>
            <td markdown="span">_NMPA Patient Nationality Code_
            <td>Select the NMPA code for patient nationality.
            <td>D.CN.1
        
        <tr>
            <td markdown="span">_NMPA Patient Race_
            <td markdown="span">For _Patient_ contacts and _Reporter_-type contacts with a _Qualification_ of _Patient_, select the patient's race.
            <td>D.CN.2

### Localized Case Product Details Section

The following _Localized Case Product Details_ section fields may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_Local MPID_
            <td markdown="span">For _External Products_, enter the region-specific Medicinal Product Identification (MPID) code on _Localized Case Product_ records. For _Company Products_, use the _Local Product Code_ field on _Case Product Registrations_ instead.
            <td>N/A
        
        <tr>
            <td markdown="span">_Related Device Information_
            <td>Enter the medical device information that may be associated with the reported adverse event.
            <td>G.k.CN.2
        
        <tr>
            <td markdown="span">_Trade Name_
            <td markdown="span">Based on the _Case Product_, Vault populates the _Trade Name_ from the related _Localized Product_ with _Chinese_ as the _Localization_.
            <td>G.k.2.2
        
        <tr>
            <td markdown="span">_Generic Name_
            <td markdown="block">Based on the _Case Product_, Vault maps the _Generic Name_ from the related _Localized Product_ with _Chinese_ as the _Localization_. If the _Generic Name_ is blank or no applicable _Localized Product_ exists, Vault maps the _Product (Coded)_ value from the _Case Product_ and appends `无中文名`.

For _External Products_ coded using WHODrug Global Chinese data, if the generic name does not include Chinese characters, manually append `无中文名` to the _Generic Name_. This supports compliant submissions to the NMPA.

            <td>G.k.CN.1
        
        <tr>
            <td markdown="span">_MAH Product_
            <td markdown="span">Indicate the registrant/holder status. For _External Products_, Vault populates `No`.
            <td>G.k.CN.3
        
        <tr>
            <td markdown="span">_CTA Approval Number(s)_
            <td markdown="block">From any active _Study Products_ related to the _Case Product_, Vault comma separates all _CTA Approval Numbers_ starting with the earliest-created _Study Product_ records.

This field has a 250-character limit. When all of the _CTA Approval Numbers_ for a _Study Product_ cannot be included within the limit, Vault maps all of that product's numbers to the _Additional CTA Approval Numbers_ field. Vault does not populate an incomplete list of _CTA Approval Numbers_ for a _Study Product_ in this field.

            <td>G.k.CN.4
            
        <tr>
            <td markdown="span">_Additional CTA Approval Numbers_
            <td markdown="span">When the _CTA Approval Number(s)_ field reaches its character limit, Vault comma separates additional _CTA Approval Numbers_ from active _Study Products_ related to the _Case Product_.
            <td>H.1

### Localized Case Product Substances Section

The following _Localized Case Product Substances_ section field may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_Local Product Code_
            <td>Enter the region-specific product code for the substance.
            <td>N/A

### Localized Case Assessment Result Section

The following _Localized Case Assessment Result_ section fields may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_Localized Assessment Result_
            <td markdown="block">Select an assessment result. For _Localized Cases_ for _China_, Vault maps a value based on the _Assessment Result_ on the global _Case Assessment Result_ as follows:

* For _Related_, Vault populates _Positive_
* For _Probably Related_ and _Reasonable Possibility_, Vault populates _Likely_
* For _Possibly Related_, Vault populates _Possible_
* For _Unlikely Related_ and _Not Related_, Vault populates _Probably Unrelated_
* For _Not Applicable_, Vault populates _Not Available_

            <td>G.k.9.i.2.r.CN.2
        
        <tr>
            <td markdown="span">_Localized Assessment Source_
            <td markdown="span">Select an assessment source. A value is required if the [_NMPA Report Classification_][8] is _Domestic Reporting Post Marketing_.
            <td>G.k.9.i.2.r.CN.1

### Narrative Section

The following _Narrative_ section field may be available: 

<table>
    <thead>
        <tr>
            <th>NMPA Localized Case Field
            <th>Field Description
            <th>NMPA E2B(R3) Data Element Mapping

<tbody>
        <tr>
            <td markdown="span">_Additional Pregnancy Related Information_
            <td>Enter any additional pregnancy-related information, such as a history of previous pregnancy or fetus outcome.
            <td>D.CN.6

## Data Syncing for Localized Cases for China {#china-sync}

When processing _Localized Cases_ that are reportable to China, Vault maps field data from global _Cases_ to foreign and domestic _Localized Cases_ upon creation. Subsequently, Vault syncs global _Case_ field data to _Localized Case_ fields in the following instances:

* During foreign _Localized Case_ syncing
* Following ad hoc changes to a domestic _Localized Case_
* Following merge to an in-flight or creation of a follow-up _Case_ from the _Inbox Item to Case Compare_ page on a domestic _Localized Case_

For the following fields, Vault syncs data from the global _Case_ to the _Localized Case_ only when the _Localized Case_ field is blank or the coded _Case Product_ has changed:

* [_Additional CTA Approval Numbers_][3]
* [_CTA Approval Number(s)_][4]
* [_Generic Name_][6]
* [_Local MAH_][2]
* [_Localized Assessment Result_][9]
* [_MAH Product_][5]
* [_Trade Name_][7]

[1]: #china-sync
[2]: #local-mah
[3]: #nmpa-add-cta
[4]: #nmpa-cta
[5]: #mah-product
[6]: #nmpa-generic-name
[7]: #nmpa-trade-name
[8]: #nmpa-report-class
[9]: #local-assess-result