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

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...

14 May 2012

The Steering Committee endorses the establishment of an S1 EWG

In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan proposing to develop new guidance on rodent carcinogenicity testing. The aim of this new topic is to introduce a more comprehensive and...