18 December 2015

The ICH E18 Guideline on Genomic Sampling and Management of Data reaches Step 2b of the ICH Process in December 2015 and now enters the consultation period (Step 3). This new guideline is proposed to provide guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval.

The draft E18 Guideline is available for download on the Efficacy Guideline page on the ICH website. You are invited to provide comments on the draft E18 Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.