1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. China NMPA E2B(R3) export

China NMPA E2B(R3) export

Summary

Oracle Argus is enhanced to schedule, generate, transmit, track, and submit E2B(R3) reports according to the Implementation guide published by NMPA.

Description

The National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration or CFDA, published the Regional implementation guide for E2B(R3) reporting in November 2019. The implementation guide defines 19 China specific E2B(R3) regional data elements and business rules regarding the submissions of E2B(R3) to the Center for Drug Reevaluation, NMPA, and to the Center for Drug Evaluation, NMPA.

Argus is now enhanced to schedule, generate, transmit, track, and submit E2B(R3) reports following the Implementation guide published by NMPA.

The following updates are implemented to support NMPA E2B(R3):
  • Case Form
  • Console
  • Interchange mapping
  • Reports generation, track, transmission and submission
  • Validation and attachments

Case Form

The following Case Form field with multi-language data entry is introduced to generate NMPA E2B(R3) reports:
  • Case Form > Product > Product Information > Related Device Comments
The following Case Form fields are enhanced for multi-language data entry to generate NMPA E2B(R3) reports:
  • Case Form > General > Reporter Information > Institution
  • Case Form > Patient and Parent > Pregnancy Information > Delivery Notes
  • Case Form > Products > Product Information > Product Name
  • Case Form > Products > Product Information > Generic Name

Console

The Standard and Flexible codelists are updated with additional factory data to generate NMPA E2B(R3) reports:
  • Console > Code Lists > Argus > Case Classification
  • Console > Code Lists > Argus > Ethnicity
  • Console > Code Lists > Flexible re-categorization > CASE_CLASSIFICATION
  • Console > Code Lists > Flexible re-categorization > ETHNIC_GROUP
  • Console > Code Lists > Flexible re-categorization > ETHNICITY
  • Console > Code Lists > Flexible re-categorization > MANUFACTURER
  • Console > Code Lists > Flexible re-categorization > CAUSALITY_CATEGORY
  • Console > Code Lists > Flexible re-categorization > ROUTE
  • Console > Code Lists > Flexible re-categorization > FORMULATION

Interchange mapping

The ICH-ICSR V3.0 MESSAGE TEMPLATE – NMPA message profile template, with default mappings for export and conformance rules according to the NMPA guidelines, is now added for E2B(R3) reporting to NMPA.

The ICH-ICSR V3.0 ACKNOWLEDGEMENT TEMPLATE – ICH existing acknowledgment profile template is used to receive acknowledgment from NMPA.

The 19 China-specific E2B(R3) regional data elements are listed in the following table:

Element number Element description Argus UI source
C.1.CN.1 Source of Reports Case Form > General > Case Classification
C.1.CN.2 Report Categories Derived from:
  • Case Form > General > Reporter Information > Country
  • Case Form > General Information > Report Type
  • Case Form > General > Study Information > Observe Study Type
C.1.CN.3 Holder Identification Code Lists > Reporting Destination > Local Company Contact > Lab Code
C.2.r.CN.1 Reporter's Email Case Form > General > Reporter Information > Email
D.CN.1 Minority Case Form > Patient > Patient Information > Ethnic Group
D.CN.2 Race Case Form > Patient > Patient Information > Race Information > Race
D.CN.3 Medical Institution Name

Data in Chinese

 Case Form > General > Reporter Information > Institution
D.CN.4 Nationality Case Form > Patient > Patient Information > Country
D.CN.5 Patient Telephone Case Form > Patient > Patient Information > Phone
D.CN.6 Pregnancy Description

Data in Chinese

 Case Form > Patient or Parent > Pregnancy Information > Delivery Notes
G.k.CN.1 Generic Name of Drug

Data in Chinese

 Case Form > Products > Product Information > Generic Name
G.k.CN.2 Related Device

Data in Chinese

 Case Form > Product > Product Details > Related Device Comments
G.k.CN.3 Is the product owned by the holder Derived from:
  • Console > Products and Licenses > License
G.k.CN.4 Approval/Acceptance Number Derived from:
  • Console > Studies > Clinical References >Reference Number
  • Console > Product > Licenses > License number
G.k.4.r.CN.1 Expiration Date/Date of Expiry Case Form > Products > Dosage Regimens > Expiration Date
G.k.9.i.CN.1 Is the reaction unexpected? Derived from:
  • Case Form > Events > Event Assessment > As Determined Listedness
G.k.9.i.CN.2 Did the reaction disappear or was the reaction relieved after the drug was withdrawn or the dose was reduced? Derived from:
  • Case Form > Events > Product Event Details > Dechallenge Results
  • Case Form > Products > Product Details > Dechallange Results
G.k.9.i.2.r.CN.1 Original Reporter/ Source of Assessment Case Form > Events > Event Assessment > Causality as Reported Source, Causality as Determined Source
G.k.9.i.2.r.CN.2 Result of Assessment Case Form > Events > Event Assessment > Causality as Reported Result, Causality as Determined Result

For details of NMPA E2B(R3) mappings, validations and appendix, refer to the ArgusInterchange8231_E2B (R3) Export Mappings.xlsx eTRM document.

Reports generation, tracking, transmission and submission

The NMPA E2B(R3) report generation, track, transmission and submission is similar to the E2B(R3) framework in Argus. The report is generated in the HL7 format, with the appropriate comments embedded in XML, for an easy identification of the data elements.

The ICSR Viewer supports three views:
  • XML view
  • HL7 view
  • Decoded view

You can send and track reports under Worklist > Bulk ICSR Transmit and Utilities > ICSR > ICSR Transmit Status. The AS2 protocol gateway support is provided to send and receive files.

Validation and attachments

The NMPA E2B(R3) profile is provided with validation rules as a part of factory data. The rules are based on the NMPA regulations. During the E2B(R3) report generation, the ICSR Validation verifies the case data against the rules and the ICSR validation report displays the list of failures.

The attachment types supported for NMPA E2B(R3) are provided as part of factory data in the newly introduced common profile switch in Reporting > E2B > File attachments allowed for the NMPA E2B(R3) Profile.

For more information on configuration and reporting, refer to the China NMPA E2B(R3) Best Practices document.

Parent topic: Enhancements to Oracle Argus Safety