ICH在其官网悄然更新了最新版的GCP E6(R3)，由于官方没有发布修订稿件的更新对照，更新的相应内容各方都在整理，本号就不多说了，点击下方“阅读原文”可以直接下载。

或复制如下链接：

https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf

The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2.

While the original E6(R3) Concept Paper stated that before the drafting of Annex 2, its scope would be further clarified, to define the nature of trials involved, in an update to the Concept Paper, the EWG subsequently determined that a separate Concept Paper was preferred for Annex 2. Further to this, an Annex 2 Concept Paper was approved in May 2023 by the ICH MC, and an E6(R3) EWG Annex 2 Sub-group was established to begin development of Annex 2.  

Work on Annex 2 will be progressed in parallel of work on the ICH E6(R3) Principles and Annex 1, with Annex 2 work initiated once the latter reaches ICH Step 2.

本号想说点儿相关的话题。

1、E6(R3)是NMPA首次作为ICH管委会成员全程参与ICH的1级指导原则的更新讨论谈判。内容上是有中国的监管及行业专家的贡献的。

2、既往受限于国情，以及规则制定权的缺位，包括GCP在内的大量ICH指导原则在中国都是经过比较深度本地化的修改后再落实的。本次E6(R3)的最终发布，中国是否能快速直接落地，行业翘首以待。截至目前为止，在国家药监局药品审评中心官网的ICH板块中，尚未出现E6(R3)的最新相关内容，搜索仅可查阅到2021年的相关培训信息。

3、E6(R3)不是终点，在本次更新的附件2（annex-2）中，指导原则对未来的“去中心化”、“真实世界”等近年来的新生要素也做出了展望。

4、最后列上ICH关于E6(R3)的主要里程碑推进表，预期2023年底可以正式发布。