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

18 October 2017

The E18 presentation available now on the ICH website

The ICH E18 Guideline on Genomic Sampling and Management of Genomic Data provides guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval. Following the adoption of this new ICH...

17 October 2017

ICH releases finalised, draft Guidelines and publishes working party membership for first time

Following its last meeting in Montreal in June 2017, the International Council for Harmonisation (ICH) has continued to progress its work with the adoption of new guidelines on pediatric clinical trials and genomic data and the...

13 October 2017

The ICH S5(R3) draft Guideline presentation available now on the ICH website

The ICH revised S5(R3) draft Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period. A training presentation has also...

28 September 2017

The ICH Assembly and MC Reports from the Montreal meeting, May/June 2017, available now on the ICH Website

In May/June 2017, the ICH Assembly and Management Committee met in Montreal, Canada, for their biannual meeting. Main decisions taken at the ICH Assembly meeting are reflected in a report including the key progress made at this...