24 February 2025
Swissmedic: Adoption of ICH GCP Guideline E6(R3) and Appendix 1 in summer 2025
On 6 January 2025, the Principles and Annex 1 of the revised ICH GCP Guideline E6(R3) were adopted at international level. They will come into force in the EU region on 23 July 2025. To meet this timeline, the Principles and Annex 1 will come into force in Switzerland in the summer of 2025. However, Annex 2 will be adopted no earlier than the beginning of 2026.
The ICH Guideline for Good Clinical Practice E6 is a guideline that establishes an international standard for the conduct, monitoring and documentation of clinical trials of medicinal products. It aims to ensure participants’ safety and well-being. It also aims to ensure the scientific integrity of the clinical trial and the reliability of the results. The new guideline takes into account new technologies, the increased volume of digital data and the increasing involvement of external service providers in the conduct of clinical trials.
For more information, see here.
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