Notice of a questionnaire survey on the revision of the ICH E6 (R2) Code of Practice for Drug Clinical Trials

November 2016, ICH issued a "comprehensive appendix of E6 (R1): The trials of drug quality management practices E6 (R2)" (hereinafter referred to as E6 (R2))But since E6 (R2) formulation, clinical trials continue to develop in experimental design and technological innovationJune 2019, ICH Assembly approved a new topic: "E6 (R3): Good Clinical Practice (GCP)"In November, "E6 (R3) Concept Paper" and "business plan" approved by the Management Committee ICH, E6 (R3) Working Group of Experts (hereinafter referred to as EWG) was established at the same time, start a comprehensive revision of the ICHGCP"E6 (R3) Concept Paper" that, through this revised plan, the GCP principles applied to increasingly diverse types of clinical trials and drug supervision and support data relevant medical decision-making, and promote technological innovation of clinical trials in any appropriateE6 (R3) will eventually be general principles, object files, Annex 1 (intervention clinical trials) and Annex 2 (additional consideration of non-traditional interventional clinical trials) constituteGeneral principles, object files and Annex 1 will replace the current version E6 (R2)EWG in this revision process and hopes to strengthen multifaceted participation, listen to opinionsaccording to ICH work arrangements, "Clinical Trials Transformation Initiative (CTTI)" to E6 (R3) EWG provide questionnaires used in the 2019 "inform ICHE6 Innovation" survey is based on the National Drug Administration Center for Drug Evaluation organized the compilation of "questionnaire: ICHE6 (R2) full revision" and "fill out the questionnaire instructions." And the need to collect domestic parties proposed changes for each entry E6 (R2) as amendedIn addition, for easy reading, translation formed the "E6 (R3) Concept Paper" Preliminary Chinese versionWe sincerely welcome the community to actively fill out this questionnaire, and timely feedback to us, to support the E6 (R3) EWG comprehensive revision of the E6 (R2) ofTime survey for one month from the date of publicationask you to fill out a questionnaire to complete the mail sent to: gkzhqyj@cde.org.cn, and indicate [E6 (R2)] questionnaire feedback in the message header, any questions please contact this emailthank you for your participation and supportState Drug Administration Center for Drug Evaluation