The Steering Committee welcomes the participation of the East African Community (EAC) as the sixth Regional Harmonisation Initiative (RHI) member of the ICH Global Cooperation Group (GCG).

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 the establishment of an E3 Implementation Working Group (IWG).

A comprehensive report of the last meeting of the ICH Steering Committee that was held in Cincinnati, OH, US on 11 - 16 June 2011 is now available on the ICH website under the SC Reports page

The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.”

Milrinone End of procedure: 09/04/2011 Date of publication: 06/07/2011

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 3).

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.

Cincinnati, 12 June 2011 – The MedDRA Management Board met in Cincinnati, Ohio, USA on 11 - 12 June 2011.

The final meeting report of the last Global Cooperation Group (GCG) meeting that was held in Fukuoka, Japan on November 9, 2010 is now available on the ICH website under the GCG Reports page.

Paediatric Regulation: Article 45 Template for AR for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No 1901/2006 (April 2025) [Track version]