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

14 November 2011

Press release from the ICH Steering Committee meeting in Seville, 9-10 November 2011

“International Harmonisation Reaches Milestone on Preclinical Safety”. Following an extended consultation period, the SC approved a revised ICH S2(R1) Guideline for genotoxicity testing and data interpretation for medicines...

8 November 2011

Press release from the MedDRA Management Board meeting in Seville, 5-6 November 2011

The Management Board Further Enhances the Use of MedDRA

1 October 2011

Updated MedDRA Guidance available for MedDRA version 14.1

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

12 September 2011

ICH E2B(R3) ICSR Implementation Guide released for consultation

The E2B(R3) Expert Working Group has finalised the Step 2 ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification