FDA published appendix to electronic transmission of individual case report safety implementation guide

The FDA as published in appendix to its guidance on the electronic transmission of individual case safety reports (ICRS) which is an implementation guide for international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use and to electronic message of the transmission of individual case safety reports.

The appendix is intended to assist reports and recipients in implementing the systems with a special focus on the recommendations come version back and forth between previous standards.

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This document is an appendix to the guide for implementing the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2: Electronic Message for the Transmission of Individual Case Safety Reports (ICSRs).”
This Appendix is intended to assist reporters and recipients (including pharmaceutical companies, authorities and non-commercial sponsors) in implementing systems with special focus on the recommendations for conversion back and forth between the previous standard, i.e., E2B(R2) and this new one, i.e., E2B(R3).
The evolution of the guideline, from E2B(R2) to E2B(R3), has the consequence that ICSRs cannot be perfectly converted from one standard version to the other (either backwards or forwards). This document presents the recommendations for conversion agreed within ICH so as to provide a reference to system providers, and a common understanding on the way to convert ICSRs and ICSR acknowledgments (ICSR ACKs) between E2B(R2) and E2B(R3).

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