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

6 September 2017

The ICH Q11 Q&A reaches Step 4 of the ICH Process

The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). These Q&As are intended to provide additional clarification and to promote convergence on the...

4 September 2017

ICH E9(R1) Addendum reaches Step 2b of the ICH Process

The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period. The ICH E9(R1) Addendum promotes...

4 September 2017

ICH S5(R3) revised Guideline reaches Step 2b of the ICH Process

The ICH S5(R3) on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.Since the implementation of the previous version of the...

14 August 2017

ICH Training Pilot Programmes Available

At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality...