On 6 January 2025, the Principles and Annex 1 of the revised ICH GCP Guideline E6(R3) were adopted at the international level. They will come into effect in the EU region on 23 July 2025. In line with this schedule, the Principles and Annex 1 are also to come into effect in Switzerland in summer 2025. Annex 2 will be adopted at a later date, coming into effect in the EU and in Switzerland no earlier than the beginning of 2026.
Adoption of ICH GCP E6 (R3) and Appendix 1 in summer 2025
24.02.2025
The ICH Guideline for Good Clinical Practice E6 establishes an international standard for the conduct, monitoring and documentation of clinical trials of medicinal products. It is designed to safeguard participants’ safety and well-being and to help ensure the scientific integrity of the trial and the reliability of the results.
Since the Guideline was first developed around two decades ago, clinical trials have become more complex. Although a revised version was issued in 2016, the need for a more comprehensive revision was apparent even at that time. This was due to the growing complexity of trial designs, the increased use of new technologies, the greater volume of digital data and the increasing involvement of external service providers in the conduct of clinical trials.
These aspects have been taken into account in the ICH Guideline E6(R3), which is now available after a revision process lasting for several years. It comprises a main document covering principles and objectives, Annex 1 (for interventional clinical trials) and Annex 2 (additional considerations for non-traditional interventional clinical trials).
The main document including the Principles and Annex 1 was adopted by the International Council for Harmonisation (ICH) on 6 January 2025. These two parts will come into effect in Switzerland in summer 2025 – around the same time as in the EU countries. The reference given in Annex 1, Number 2 of the ClinO will be duly amended at the same time.
Annex 2 of the revised ICH Guideline E6 is still undergoing a public consultation and is expected to come into effect no earlier than the beginning of 2026.
Until the date on which the revised ICH Guideline E6(R3) comes into effect, the current version ICH Guideline E6(R2) remains applicable.
Further links
International Council for Harmonisation (ICH)
Public consultation on Annex 2 - International Council for Harmonisation (ICH)