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

29 March 2017

Confirmed Working Groups to meet at the upcoming ICH meeting in Montreal

The ICH Management Committee identified the Expert & Implementation Working Groups to meet at the upcoming ICH meeting to take place in Montreal. The complete list is now available on the ICH website under Meetings/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...