12 September 2011

The E2B(R3) Expert Working Group has finalised the Step 2 ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification which includes the key parts of the updated E2B(R3) Guideline. As there are significant differences between the data models for E2B(R2) and E2B(R3), a Backwards and Forwards Compatibility (BFC) document has been produced as an Appendix to the Implementation Guide to define the compatibility of data elements between the two versions of the specification.

This document is now undergoing public consultation and is available for download, along with further information, under the ESTRI pages under ICSR - Public Consultation.