FDA E2B(R3) 电子传输个别案例安全报告实施指南——数据元素和信息规范； 和实施指南的附录 — 向后和向前兼容性

中文标题：

FDA E2B(R3) 电子传输个别案例安全报告实施指南——数据元素和信息规范； 和实施指南的附录 — 向后和向前兼容性

英文标题：

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

发布机构：

美国食品和药品监督管理局

发布日期：

2022-06-01

简要介绍：

The E2B(R3) document package comprises four materials. The main document is the ICSR Implementation Guidance, which includes E2B(R3) data elements and message specifications; the BFC document is an appendix to the guide provided separately. The ICH ICSR XML schema set includes all necessity schema files for creating ICH ICSR messages and ICH Acknowledgement messages plus other reference schema files. The ICH ICSR reference instance is created to be aligned with these schemas and the ICH ICSR Implementation Guidance. Although the same reference instance is included in the guidance, it is provided separately as an xml file.

• E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification (PDF - 1.65MB)
• Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility (PDF - 598KB)
• FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (April 2022) (PDF - 36KB)
• ICH ICSR XML Schema Set (version 2.5) (zip file 979KB)
• ICH ICSR Reference Instances (version 3.1) (zip file 17KB)
• ICH ICSR Examples Instances (version 2.0) (zip file 112KB)

Additional documents provided for information

This Information Paper explains the short history of E2B, relationship to ICH M5 and ISO IDMP standard, and ICH position on regional requirements for the exchange of ICSR messages.

•  Information Paper (PDF - 173KB)
• Technical Information (PDF - 1.3MB)

This Information Paper explains the E2B(R3) Object Identifiers (OIDs).

• OID Information Paper (PDF - 221KB)
• ICH ICSR E2B(R3) OIDs (zip file 48KB)

 
BFC materials
The conversion rules between E2B(R2) and E2B(R3) messages are provided in the compatibility mapping spreadsheet. This is a base document of the BFC document above, and the conversion style-sheets are developed as implementation of these rules. The example data are not derived from the compatibility mapping spreadsheet, but present differences in E2B(R2) and E2B(R3) messages. Note that the example files do not correspond to the upgrade and down grade of each other.

• Backwards and Forwards Compatibility Mapping (excel file - 147KB)
• E2B Conversion style-sheets (zip file 66KB)

If necessary, additional materials may be added during the public consultation.

• International Conference on Harmonisation - Efficacy

相关资料下载：