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

20 February 2017

The ICH Q11 draft Q&A presentation available now on the ICH website

The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials,...

17 February 2017

The E11(R1) draft Addendum presentation available now on the ICH Website

The ICH E11(R1) draft Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process and is currently under public consultation. This Addendum was proposed to address new...

10 February 2017

The E6(R2) presentation available now on the ICH Website

ICH E6(R1) on Good Clinical Practice (GCP) has been amended to encourage implementation of improved and more efficient approaches to clinical trials design, conduct, oversight, recording and reporting while continuing to ensure...

8 February 2017

The ICH Assembly and MC Reports from the Osaka meeting, November 2016, available now on the ICH Website

In November 2016, the ICH Assembly and Management Committee met in Osaka, Japan, for their biannual meeting. Main decisions taken at the ICH Assembly meeting are reflected in a report including the key progress made at this...