GCP R3 Release date timelines
The International Council for Harmonization (ICH) proposed the updated to GCP from E6R2 to E6R3 back in June 2019. Fast forward to today as we are approaching the implementation of E6R3 sometime in Q4 2024. The ICH works to update their guidelines in a very structured process which you will see outlined in the figure below. Guidelines are developed and revised through this 5 step process which can take several years. This is done to allow adequate feedback and input from stakeholders including professionals and regulatory bodies in the ICH member countries. Some key dates for the ICH GCP E6R3 development are noted below:
Step 1- Consensus Building- Technical Document
June 2019: Endorsement by ICH for update to R3 April 2021: Stakeholder engagement period and input collection April 2022: GCP E6R3 Draft Principles published
Step 2- ICH Parties Consensus on Technical Document & Adoption of draft guideline by regulators
May 2023: Consensus reached for Principles and Annex 1 and adoption ICH member review
Step 3- Regulatory Consultation and Discussion
October 2023: Stage I- Regulatory consultation in ICH regions July 2024 (expected): Stage II-Consultation comments review and consensus October 2024 (expected): Finalization of Expert Draft Guidance based on stakeholder feedback and Expert Working Group sign off
Step 4: Adoption of ICH Harmonized Guideline
Fall 2024 (expected): Final GCP E6R3 document adopted by ICH Regulatory Members of the ICH Assembly
Step 5- Implementation
Fall 2024 Onwards: Regulatory implementation in ICH regions (variable by country).
Conclusion
While we had expected the Experts Draft Guideline (Step 3 Stage II) to be released in July 2024 we have not seen this release from ICH as of mid-August. Based on the meeting minutes from the Fukuoka Japan meeting on 05Jun2024, we should still expect finalization of the Expert Draft Guidance in October 2024. Stay tuned to Advantage Clinical and the ICH Press release page (https://www.ich.org/page/press-releases) for updates as we move ever closer to GCP E6R3 finalization this fall! Advantage Clinical, working with the draft guideline, is already working on a GCP E6R3 eLearning course so you and your team and stay current on Good Clinical Practice. Once finalized we will make final edits to the course and release to production. As an established clinical research eLearning provider and GCP trainer since 2016 we are ready to hit the ground running with the E6R3 release. This course is available for individual users as well as for larger groups.
Visit our GCP Training Page to learn more
click to image to expand- GCP R3 Release date timelines
