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Guidance Issuing OfficeCenter for Drug Evaluation and Research
Implementation of ICH E2B(R3)
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.
This Information Paper explains the E2B(R3) Object Identifiers (OIDs).
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.
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:
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.