FDA 发布 E2B(R3) 个例安全报告电子传输实施指南及前后向兼容附录（2026年10月）
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 October 2026
FDA 发布最终版指南，采用 E2B(R3) 数据标准并列出个例安全报告电子传输所需的实施文件。主文件为 E2B(R3) ICSR 实施指南，涵盖数据元素与消息规范，附录 I(B) 给出 E2B(R2) 与 E2B(R3) 的前后向兼容和转换规则。文件由 CDER 与 CBER 发布，备案号 FDA-2011-D-0720，另附 FDA 区域实施指南（2024年8月）。
材料汇总 FDA 采用 E2B(R3) 数据标准后配套的实施指南、XML 模式集与区域实施文件，便于按文件定位具体技术附件。
GUIDANCE DOCUMENT
Final Level 2 Guidance
- Docket Number:
- FDA-2011-D-0720
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Implementation of ICH E2B(R3)
FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for implementing the E2B(R3) data standards. The main document is the E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification, which includes E2B(R3) data elements used in the electronic transmission of different types of ICSRs and message specifications. The Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide —Backwards and Forwards Compatibility (BFC) document is an appendix to the Implementation Guide. The ICH ICSR XML Schema Set is a collection of files that provide information needed to create ICSR messages and acknowledgement messages, and additional reference materials. The ICH ICSR Reference Instances show examples of the coding of an ICSR and an acknowledgement message.
- E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification (PDF - 1.65 MB)
- Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility (PDF - 598 KB)
- ICH ICSR XML Schema Set (version 2.5) (zip file - 878 KB)
- ICH ICSR Reference Instances (version 3.1) (zip file - 16 KB)
- ICH ICSR Examples Instances (version 2.0) (zip file - 112KB)
FDA Regional Implementation Guide for E2B(R3)
The FDA Regional Implementation Guide for E2B(R3) is a technical specifications document that describes FDA’s technical approach for submitting ICSRs, for incorporating its regionally controlled terminology, and for adding AEMS regional data elements that are not addressed in the E2B(R3) Electronic Transmission of ICSRs Implementation Guide for drug and biological products:
- FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (August 2024) (PDF - 36KB)
Additional documents provided for information
Information Paper - Step 3 Release E2B(R3) 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 - Step 3 Release E2B(R3) (PDF - 173KB)
- Technical Information (PDF - 1.3MB)
Information Paper – Use of OIDs & UUIDs in E2B(R3) explains the E2B(R3) Object Identifiers (OIDs) and Universally Unique Identifiers (UUIDs).
- OID Information Paper (PDF - 597 KB)
- ICH ICSR E2B(R3) OIDs (zip file - 89 KB)
Information Paper Regarding Alignment with ICH E2D(R1) Guideline explains the alignment of ICH E2B(R3) data standards with the revised ICH E2D guideline (referred to as ICH E2D(R1)).
Backwards and Forwards Compatibility materials
The conversion rules between E2B(R2) and E2B(R3) messages are provided in the Backwards and Forwards Compatibility Mapping spreadsheet, which is a base document of the Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility document below. The E2B Conversion style-sheets are developed as a tool illustrating how ICSR messages can be converted from one E2B data standard to another E2B data standard (i.e., E2B(R2) to E2B(R3)).
- Appendix I (B) to the ICH E2B(R3) ICSRs Implementation Guide — Backwards and Forwards Compatibility (PDF - 598KB)
- Backwards and Forwards Compatibility Mapping (excel file - 147 KB)
- E2B Conversion style-sheets (zip file - 66 KB)
Contact [email protected] with any questions related to E2B(R3) implementation.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0720.
来源：FDA What's New Related to Drugs · fda.gov