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

10 August 2011

The Steering Committee endorses the establishment of an E3 IWG

In June 2011, the ICH Steering Committee approved the E3 Q&As Concept Paper to develop Questions and Answers to facilitate the application of the ICH E3 Guideline: Structure and Content of Clinical Study Reports and endorsed...

8 August 2011

Follow in details the main decisions taken by the ICH governing body in June 2011

A comprehensive report of the last meeting of the ICH Steering...

8 July 2011

ICH S6(R1) Step 4, M3(R2) Q&As Step 4 and Quality IWG Points to Consider published on the ICH website

At the ICH Steering Committee meeting in Cincinnati, OH, US in June 2011, several documents were finalised and are now available for public awareness on the ICH website:

28 June 2011

ICH Q11 reaches Step 2 of the ICH Process

The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 2 of the ICH Process in May 2011 and now enters the consultation period (Step...