You will find in this section the recent latest new from the ICH.

15 July 2014

ICH M7 Guideline reaches Step 4 of the ICH Process

The purpose of this new ICH Guideline is to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity. Furthermore, it is intended to resolve questions such as whether impurities with similar alerts...

8 July 2014

Press release ICH Steering Committee meeting in Minneapolis, June 2014

The SC is pleased to announce the decision that Heath Canada (HC) and Swissmedic are now Steering Committee members. In recognition of their historical involvement and commitment to ICH, Health Canada and Swissmedic ...

21 May 2014

Agenda Papers for the upcoming ICH SC meeting available for download

The Steering Committee will meet in Minneapolis, MN, USA from May 31 to June 5 to discuss ongoing harmonisation activities. The SC is pleased to welcome to this meeting representatives from several RHIs, including ASEAN,...

11 April 2014

ICH E2C(R2) Q&As available on the ICH website

In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR from an...