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

9 May 2019

The ICH E8(R1) reaches Step 2b of the ICH Process

The ICH E8(R1) draft Guideline on General Consid√©rations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period. Further information can be found on the E8(R1)...

5 April 2019

Call for Expression of Interest for ICH Training Associates

ICH is conducting a Call for Expression of Interest for ICH Training Associates with a view to exploring the possibility of contracting appropriate accredited non-profit training organisations/institutions, initially for 1-year...

22 March 2019

The ICH Q3D(R1) Guideline reaches Step 4 of the ICH Process

The ICH Q3D(R1) Guideline for Elemental Impurities reached Step 4 of the ICH Process in March 2019 and now enters into the implementation period (Step 5). The ICH Q3D Guideline for Elemental Impurities is a quality guideline...

20 March 2019

Publication of the ICH M10 draft Guideline and Presentation

The ICH M10 draft Guideline on Bioanalytical Method Validation reached Step 2b of the ICH Process on the 26 February 2019 and now enters the consultation period. The M10 draft Guideline provides recommendations for the validation...