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

30 November 2017

Press release ICH MedDRA Management Committee meeting in Geneva, Switzerland, November 2017

The MedDRA Management Committee met in Geneva, Switzerland on 11-12 November 2017. Ms. Sophie Sommerer (Health Canada, Canada) was appointed as Chair with the unanimous support of the Committee to serve until November...

30 November 2017

Press release ICH Assembly meeting in Geneva, Switzerland, November 2017

The International Council for Harmonisation (ICH) met in Geneva, Switzerland on 11 to 16 November 2017. Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member....

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...