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

31 August 2018

The ICH M9 draft Guideline presentation available now on the ICH website

The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period. Additionally, a Step 2 Presentation has...

21 August 2018

The ICH E9(R1) Step 2 Training Material available now on the ICH website

The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1) Addendum, and is intended to support the scientific community in the comprehension of a new framework...

15 August 2018

The ICH Q3D(R1) draft Guideline presentation available now on the ICH website

The ICH Q3D(R1) Revision to the Q3D Cadmium Inhalation PDE reached Step 2b of the ICH Process in May 2018 and entered the public consultation period. Additionally, a Step 2 Presentation has been developed by the Expert Working...

9 August 2018

The reports of the ICH Assembly and MC meetings in Kobe, Japan, in June 2018, available now on the ICH Website

In June 2018, the ICH Assembly and Management Committee met in Kobe, Japan for their bi-annual meeting. To ensure transparency in the ICH process, reports from both meetings are made publicly available so that all stakeholders...