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

12 September 2017

The ICH E11(R1) Addendum reaches Step 4 of the ICH Process

The ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5). This Addendum is...

11 September 2017

The ICH E18 Guideline reaches Step 4 of the ICH Process

The ICH E18 Guideline on Genomic Sampling and Management of Data reached Step 4 of the ICH Process in September 2017 and now enters into the implementation period (Step 5). This new guideline is proposed to provide guidance on...

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...