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

6 December 2011

Additional Q8/Q9/Q10 Points to Consider added on the ICH website

At its meeting in Seville, in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process...

4 December 2011

Updated ESTRI webpages

At their meetings in Seville, in November 2011, the ICH E2B(R3) and M8 working groups finalised further documentation related to the development of ICH electronic standards.M8 eCTD: The Q&A document summarizing the results...

28 November 2011

ICH S2(R1) Reaches Step 4 of the ICH Process

The ICH S2(R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use reached Step 4 of the ICH Process in November 2011 and now enters the Implementation phase (Step 5).This...

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...