2 Introduction
This document lists best practices and recommendations for generating NMPA E2B(R3) report from Argus.
The National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration or CFDA, published the Regional Implementation Guide for the Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification on November 22, 2019.
The guidelines include the following:
- The post-marketing ICSRs need to be submitted to NMPA in the E2B(R3) format along with the regional elements to comply with the final Implementation Guide. This is optional from July 01, 2019 and mandatory from July 1, 2022.
- The SUSAR (Suspected Unexpected Serious Adverse Reactions) ICSRs from
clinical trials approved on or after May 1, 2018 must be transmitted in E2B(R3)
format based on the ICH guidelines in Chinese for Narratives and Reaction reported
by source (without regional elements). This is optional from May 01, 2018 and
mandatory from May 01, 2019.
Note:
NMPA has not published yet the effective date for submitting the SUSAR ICSRs in E2B(R3) format along with the regional elements (as of November 2021). For more information about the steps to create the E2B(R3) reports for clinical trial cases, refer to the article 2393471.1 on My Oracle Support.
It is recommended to switch to the NMPA E2B(R3) out-of-the-box profile for clinical trial cases only after NMPA publishes the effective date.
Argus supports out-of-the-box E2B(R3) profile to submit PMSR and CT cases to the China Health Authority NMPA.
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 Re-evaluation, NMPA, and to the Center for Drug Evaluation, NMPA.
| Element ID | Element description (English) | Element description (Chinese) |
|---|---|---|
| C.1.CN.1 | Source of Report |  |
| C.1.CN.2 | Report Categories |  |
| C.1.CN.3 | Holder Identification |  |
| C.2.r.CN.1 | Reporter's Email |  |
| D.CN.1 | Minority |  |
| D.CN.2 | Race |  |
| D.CN.3 | Medical Institution Name |  |
| D.CN.4 | Nationality |  |
| D.CN.5 | Patient Telephone |  |
| D.CN.6 | Pregnancy Description |  |
| G.k.CN.1 | Generic Name of Drug |  |
| G.k.CN.2 | Related Device |  |
| G.k.CN.3 | Is the product owned by the holder? |  |
| G.k.CN.4 | Approval/Acceptance Number |  |
| G.k.4.r.CN.1 | Expiration Date/ Date of Expiry |  |
| G.k.9.i.CN.1 | Is Reaction unexpected? |  |
| 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? |  |
| G.k.9.i.2.r.CN.1 | Original Reporter/ Source of Assessment |  |
| G.k.9.i.2.r.CN.2 | Result of Assessment |  |