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

19 May 2016

ICH S3A Q&As reaches Step 2b of the ICH Process

The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step...

8 April 2016

S1 Regulatory Testing Paradigm of Carcinogenicity in rats - Status Report

In April 2016, further to the update of the Regulatory Notice Document (RND) in January 2016, the S1 Expert Working Group has completed a Prospective Evaluation Period Status Report. This Status Report which provides a brief...

21 March 2016

The Q3D Training Modules 0 to 7 available now on the ICH Website

The Q3D Training Modules 0-7 (Module 0: Overview; Modules 1-7 on key safety and quality topics) can now be found on the ICH website. The Q3D Guideline aims to provide a global policy for limiting elemental impurities in drug...

23 February 2016

ICH Information Day at the Euro DIA in Hambourg

On 6 April 2016, the Drug Information Association (DIA) in collaboration with the European Commission (EC) and the European Medicines Agency (EMA) are organising an “Information Day on ICH”. The Information Day will focus on the...