E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility

 

Issue Date: April 29, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final

E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility

This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Electronic Transmission of Individual Case Safety Reports (ICSRs)’.

Download the Guidance Document