11 September 2017

The ICH E18 Guideline on Genomic Sampling and Management of Data reached Step 4 of the ICH Process in September 2017 and now enters into the implementation period (Step 5).

This new guideline is proposed to provide guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval.

The ICH E18 Guideline is available for download on the Efficacy Guideline page of the ICH website.