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

1 October 2012

Updated MedDRA Guidance available for MedDRA version 15.1

The ICH M1 "Points to Consider" Working Group updated the "MedDRA Term Selection" and the “Data Retrieval and Presentation” documents.

3 July 2012

Press release from the ICH Steering Committee meeting in Fukuoka, 6-7 June 2012

The six official ICH parties have agreed on new principles of governance which better define the roles of regulator and industry parties within ICH. This action will highlight ICH’s longstanding premise that the regulators have...

21 June 2012

E3 Q&As on Structure and Content of Clinical Study Reports available on the ICH website

In June 2012, the ICH E3 Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing Content and Structure, Appendices and Terminology questions. This supplementary Questions...

3 June 2012

Press release from the MedDRA Management Board meeting in Fukuoka, 2-3 June 2012

The MSSO provided data on user uptake of the new MedDRA Version Analysis Tool (MVAT). MVAT assists users in understanding the differences between any two versions of MedDRA. Over 150 organisations have used MVAT since its launch...