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

7 August 2015

ICH M4E(R2) Guideline reaches Step 2b of the ICH Process

The ICH M4E(R2) Guideline reaches Step 2b of the ICH Process in August 2015 and now enters the consultation period (Step 3). The Section 2.5.1 on Product Development Rationale and Section 2.5.6 on Benefits and Risks Conclusions...

30 July 2015

ICH E6(R2) Integrated Addendum reaches Step 2b of the ICH Process

The Integrated Addendum of the ICH E6 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3). The E6 Integrated Addendum has been developed to complement the harmonised ICH E6...

29 July 2015

ICH Q3C(R6) Revised PDE for Methyl isobutyl ketone and New PDE for Triethylamine

The ICH Expert Working Group (EWG) responsible for the maintenance of the Q3C Guideline has revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK) which was listed in ICH Q3C(R5) as a Class 3 solvent...

27 July 2015

Follow in details the main decisions taken by the ICH SC in June 2015

A comprehensive report of the last ICH meeting that was held in Fukuoka, Japan on 10-11 June 2015 is now available on the ICH website under the SC Reports page.This report outlines the main decisions taken by the ICH Governing...