The ICH E6 (R3) Guideline will take effect on July 23, 2025, having reached step 5 of the ICH process in Europe.
The overarching principles and Annex 1 have been adopted by ICH and CHMP and will come into effect in June 2025.
The EMA plans to implement the ICH E6(R3) guideline on July 23, 2025. Until then, the current version, E6(R2), will remain in effect, with a sunset date of June 11, 2025. Following the conclusion of the public consultation (PC), the adoption of Annex 2 is anticipated to be finalized by mid-2025.
Background
The ICH E6(R3) “Good Clinical Practice” Guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. This guideline introduces innovative and adaptable provisions to address various types of clinical trials and settings, aligning with advancements in technology and methodology. It emphasizes a risk-based, fit-for-purpose approach to trial design, operations, and technology, with a strong focus on transparency through trial registration, results reporting, and enhancements in the informed consent process.
E6(R3) features a more streamlined structure, including:
- An overarching principles document
- Annex 1 (focused on interventional clinical trials)
- Annex 2 (addressing non-traditional interventional trials)
These principles are interdependent, aiming to promote ethical and efficient trial conduct while ensuring the reliability of trial results.
The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial. Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials. Additional annexes may be developed to respond to interested parties' needs and address emerging innovations in trial design and conduct.
This guideline should be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials, including multiregional trials.
This guideline builds on the core concepts outlined in E8(R1) Revision of General Considerations for Clinical Studies (E8(R1) Introductory Overview Video). Key elements include fostering a quality culture, proactively integrating quality into clinical trial design and drug development planning, identifying critical factors for trial quality, and engaging relevant stakeholders as appropriate. It also advocates for a proportionate, risk-based approach to trial conduct, ensuring efficiency without compromising integrity.
Document Source: EMA ICH E6 Good Clinical Practice - Scientific Guideline
Further information can be found on the E6(R3) page,