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

25 July 2018

The ICH S9 Q&A presentation available now on the ICH website

The ICH S9 Questions and Answers (Q&As) on the Nonclinical Evaluation for Anticancer Pharmaceuticals, reached Step 4 of the ICH Process in April 2018. Following the adoption of this Q&A, a training presentation has...

23 July 2018

The ICH Q11 Q&A training material 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), are intended to provide additional clarification and to promote...

27 June 2018

ICH M9 reaches Step 2b of the ICH Process

The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period. The M9 draft Guideline provides recommendations to support the...

22 June 2018

Press release ICH Assembly meeting in Kobe, Japan, June 2018

The International Council for Harmonisation (ICH) met in Kobe, Japan on 2 – 7 June 2018. In one of the remaining steps of implementing the 2015 reforms of ICH, the Assembly elected additional members to the Association’s...