On 6 January 2025, the Principles and Annex 1 of the revised ICH GCP Guideline E6(R3) were adopted at the international level. They came into effect in the EU region on 23 July 2025. On August 15, 2025 the Principles and Annex 1 will come into effect in Switzerland. 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.
Entry into force of ICH GCP E6 (R3) and Appendix 1 on 15 August 2025
23.07.2025
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 on August 15, 2025. 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.
The current version of ICH Guideline E6(R2) will remain valid until August 15, 2025, the date on which the revised ICH Guideline E6(R3) comes into force in Switzerland.
22.12.2025
Information from Swissmedic and swissethics on ICH GCP E6(R3) training requirements for investigators.
Swissmedic and swissethics expect that all principal investigators involved in the conduct of clinical trials who currently hold a GCP E6(R2) certificate undertake and document a self-study of the revised guideline ICH GCP E6(R3). Investigators who already have a GCP E6(R3) or a refresher GCP E6(R3) certificate do not have to take the self-study. Training material for a self-study is available here (ICH.org / efficacy guidelines / E6(R3) presentation & training).
In light of the expected finalisation of Annex II of the ICH GCP E6(R3) guideline in January 2026, it is also expected that all principal investigators involved in clinical trials who currently hold a GCP E6(R2) certificate will complete a GCP E6(R3) refresher course within one year of Annex II coming into force in Switzerland or, at a minimum, register for a swissethics recognized course within that timeframe. The list of recognized GCP E6(R3) refresher courses is published here (swissethics.ch / training / GCP-courses).
Principal investigators involved in approved clinical trials are not required to inform the ethics committees or submit the GCP certificates but must document their trainings in the training logs/CVs at the research site.
Swissmedic and swissethics recommend that site staff complete a GCP refresher course within one year of the revised ICH GCP E6 Annex II coming into force in Switzerland. The site staff should not send the GCP certificates to the ethics committees but document their training in the training logs/CVs at the research site.
Swissmedic / swissethics
Further links
ICH information on the ICH Guideline E6(R3)
(www.ich.org)