The update to the ICH GCP E6 (R3) guideline is currently in its final stages. Step 3 and 4 are, as currently discussed in the ICH Assembly meeting in Japan, expected around October 2024. If that timeline indeed is met, the updated Good Clinical Practice Principles and Annex I will be adopted in October 2024. This allows for regional implementation to commence from that point, which could be within a timeframe of 1 month, depending on the region.
In this article, we have incorporated the status of the documents that form the latest version of ICH GCP, known as R3, in the ICH formal procedure steps to update guidelines. In previous blogs, we’ve covered the upcoming changes that are coming to the Principles. For more details on the revised content of the Principles, Annex 1 and Annex 2, please read part 1 and part 2 of our ICH GCP R3: What Should We Expect? series.
Read about the process for adopting guidelines in this blog, to learn more about the timelines and be prepared for the ICH GCP E6 (R3) update.
ICH Formal Procedure Steps for Updates on Guidelines
The ICH Formal Procedure for adopting a new guideline involves five structured steps designed to ensure thorough development, consensus, and harmonization.
Step 1: Consensus Building
The Expert Working Group (EWG) develops a draft Technical Document, based on the Concept Paper and Business Plan approved by the ICH Assembly.
The EWG communicates via various means, including face-to-face meetings at biannual Assembly meetings, to reach consensus.
Once consensus is reached, the draft is submitted to the Assembly for adoption under Step 2.
Principles and Annex 1
Step 1 started with an endorsement by the ICH Assembly in June 2019. A session was organized in April 2020 to engage stakeholders resulting in Draft Principles being published in April 2021. During a global web conference in May 2021 an update on the progress of the draft Principles was presented, as steps towards Step 2.
Annex 2
The annex 2 sub-group was established in April 2023, The draft Annex 2 document was shared in April 2024 ahead of Step 1 sign-off. Step 1 of Annex 2 is expected by August 2024.
Step 2a: Confirmation of Consensus on the Technical Document
The ICH Assembly reviews the draft and ensures there is sufficient scientific consensus for the document to proceed to regulatory consultation.
Step 2a: Confirmation of Consensus on the Technical Document
The ICH Assembly reviews the draft and ensures there is sufficient scientific consensus for the document to proceed to regulatory consultation.
Principles and Annex 1
- Step 2 was reached in May 2023.
Annex 2
- Step 2a/b of Annex 2 are expected by August 2024.
Step 2b: Adoption of Draft Guideline by Regulatory Members
Regulatory Members of the ICH review and endorse the draft guideline, allowing it to proceed to the consultation phase.
Principles and Annex 1
- Step 2b was reached on 19 May 2023
Annex 2
- Step 2a/b of Annex 2 are expected by August 2024.
Step 3: Regulatory Consultation and Discussion
Stage I: The draft guideline undergoes wide-ranging consultation within ICH regions and may receive comments from other regions.
Stage II: The EWG reviews and addresses comments received, working towards consensus on a revised draft.
Stage III: The revised draft is finalized and signed by the EWG experts, then submitted for adoption under Step 4.
Principles and Annex 1
Stage I: Public consultation deadlines were between August and October 2023.
Stage II: The updated draft based on comments received is to be shared by July 2024 ahead of Step 3 sign-off.
Stage III: Step 3 sign-off is expected by October 2024.
Annex 2
No status.
Step 4: Adoption of an ICH Harmonized Guideline
The ICH Assembly reviews and adopts the finalized guideline, confirming sufficient consensus among all members.
Principles and Annex 1
Step 4 is expected by October 2024.
Annex 2
No status.
Step 5: Implementation
The harmonized guideline moves to regulatory implementation in ICH regions, following their respective national/regional procedures.
Principles and Annex 1
Step 5 is expected as of November 2024, if adoption of the finalized GCP Principles and Annex 1 guideline by the ICH Assembly happens according to plan in October 2024.
Annex 2
No status.
Implications for Implementation
Once adopted in October 2024, the ICH GCP E6 (R3) guideline will be ready for implementation in the various ICH regions. Historical data shows that the timeframe between adoption and implementation can vary widely—from as short as one month, as seen in the EU with the last ICH-GCP R2 update, to several years.
This structured and collaborative approach ensures that the new ICH GCP E6 (R3) guidelines will be harmonized across regions, facilitating a unified standard for good clinical practice globally.
As updates are made to the guideline, GCP Central is committed to bringing these to you as soon as they are available via our range of ICH-GCP training (Including WMO GCP for those working in research in the Netherlands). Keep your training up to date, on the go with our myGCP platform.
Source: ICH Assembly Meeting Agenda, 4-5 June 2024 Fukuoka, Japan.
