Notification on Public Solicitation of Implementation Suggestions for ICH E6(R3) Guideline Good Clinical Practice and Draft Annex 1

The ICH E6(R3) Guideline: Good Clinical Practice and Draft Annex 1 has entered the third stage of public consultation for the region. In accordance with the relevant ICH regulations, regulatory members of the ICH are required to collect feedback on the draft guidance documents for Stage 2b from their respective regions and report it back to the ICH.

Please see the attached document for the original English text of the ICH E6(R3) Guideline: Good Clinical Practice and Annex 1. We are now publicly soliciting opinions on the content of the guidance document.

If you have relevant suggestions, please provide feedback to the contact person's email address before August 31, 2023.

Contact person: Ma Runyi.

Email: e6r3fankui@cde.org.cn.