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:

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:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
NMPA Report Classification Select the NMPA report classification type. C.1.CN.2
NMPA Report Source Select the source of the report. C.1.CN.1
Local New Info Date/Time Enter the latest date additional information was received about the Localized Case. Use the calendar to select the date or enter the date manually. C.1.5
Local MAH

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
 C.1.CN.3

Localized Case Contacts Section

The following Localized Case Contact section fields may be available:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
NMPA Report Source For Reporter-type Case Contacts, select the source of the report. C.1.CN.1
NMPA Patient Nationality For Patient-type Case Contacts, enter the 2-letter Chinese nationality code. D.CN.1
NMPA Patient Nationality Code Select the NMPA code for patient nationality. D.CN.1
NMPA Patient Race For Patient contacts and Reporter-type contacts with a Qualification of Patient, select the patient’s race. D.CN.2

Localized Case Product Details Section

The following Localized Case Product Details section fields may be available:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
Local MPID 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. N/A
Related Device Information Enter the medical device information that may be associated with the reported adverse event. G.k.CN.2
Trade Name Based on the Case Product, Vault populates the Trade Name from the related Localized Product with Chinese as the Localization. G.k.2.2
Generic Name

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.

 G.k.CN.1
MAH Product Indicate the registrant/holder status. For External Products, Vault populates No. G.k.CN.3
CTA Approval Number(s)

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.

 G.k.CN.4
Additional CTA Approval Numbers 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. H.1

Localized Case Product Substances Section

The following Localized Case Product Substances section field may be available:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
Local Product Code Enter the region-specific product code for the substance. N/A

Localized Case Assessment Result Section

The following Localized Case Assessment Result section fields may be available:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
Localized Assessment Result

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
 G.k.9.i.2.r.CN.2
Localized Assessment Source Select an assessment source. A value is required if the NMPA Report Classification is Domestic Reporting Post Marketing. G.k.9.i.2.r.CN.1

Narrative Section

The following Narrative section field may be available:

NMPA Localized Case Field Field Description NMPA E2B(R3) Data Element Mapping
Additional Pregnancy Related Information Enter any additional pregnancy-related information, such as a history of previous pregnancy or fetus outcome. D.CN.6

Data Syncing for Localized Cases for China

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: