ICH E6(R3) draft Guideline "Good Clinical Practice (GCP)" Principles and Annex 1 are now at the Step 3 of regional public consultations. As required by the relevant ICH rules, ICH Regulatory Members should collect comments on the Step 2b draft Guideline from their regions and provide the comments to ICH.

　　The original English version and translated Chinese version of the ICH E6(R3) draft Guideline and Annex 1 are attached.

　　If there are any relevant comments, please send them by email before August 31, 2023.

　　Contact person: MA Runyi

　　Email address: e6r3fankui@cde.org.cn

　　Attachments:

　　1.[English Ver]ICH E6(R3) draft Guideline: Good Clinical Practice (GCP) Principles and Annex 1

　　2.[Chinese Ver]ICH E6(R3) draft Guideline: Good Clinical Practice (GCP) Principles and Annex 1

　　3.Template for Public Consultation Comments

　　4.Guidance for Stakeholder Public Consultation for ICH E6(R3) draft Guideline: Good Clinical Practice (GCP) Principles and Annex 1