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.

excerpt from document

full text here

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).


For Assistance with Regulatory Planning and Execution of Clinical Trials Click Here


Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.


Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Fill Out the Short Form Below…




Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”