11 July 2016

The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT).

The draft E17 Guideline is available for download on the Efficacy Guideline page on the ICH website. You are invited to provide comments on the draft E17 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.