16 December 2010

The ICH Steering Committee has approved the development of a new ICH E2C(R2) Guideline to replace the current ICH E2C(R1) Guideline “Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs”. This work will be undertaken along with a general evaluation of ICH pharmacovigilance guidance, which will include the conduct of a gap and potential improvement analysis of ICH E2C, E2E and E2F Guidelines. The Expert Working Group which will be tasked with this work will also be charged with developing a plan for review of other ICH guidelines for presentation to the ICH Steering Committee. The development of the Concept Paper for this new work item was sponsored by the EU, with input from pharmacovigilance experts who met recently in Fukuoka to brainstorm on this topic.