5月19日，ICH官网更新了E6（R3）草案，E6（R3）由一份总体原则和目标文件、附件1和附件2组成。

ICH E6(R3) Principles, Annex 1 and Annex 2

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 .

Draft Principles

In April 2021, acknowledging the wide and substantial impact of ICH E6, and prior to the reaching of ICH Step 2 (which was subsequently reached in May 2023), the ICH Management Committee made available a draft, work-in-progress version of the updated principles from the ICH E6(R3) EWG in order to facilitate transparency and common understanding.

E6(R3) Stakeholder Engagement

In April 2020 to engage stakeholders for the revision of ICH E6(R3) with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials, and a summary of the E6(R3) Stakeholder Engagement Approach was made available.

Additionally, the E6(R3) EWG held a global web conference in May 2021 to present the Update on Progress to the draft guideline of the E6 GCP principles. The Web Conference Report is available for download and a link to the Video Presentation of the web conference is available to watch on ICH YouTube's channel in the Web Conference box. More information is also available on the Public Events page.

Rapporteur: Dr. Khair ElZarrad (FDA, United States)

Regulatory Chair: Mr. Peter Twomey (EC, Europe)

Date of Step 2b : 19 May 2023