ICH Guideline – Good clinical practice

The International Council for Harmonisation's Good Clinical Practice Guideline (ICH Guideline) and its Annex 1 have been updated. They will come into effect in Switzerland in summer 2025. As of 2026, GCP courses recognized by Swissethics will have to be updated.

The ICH Guideline 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. Under Swiss law, clinical trials in Switzerland must be conducted in accordance with the rules of Good Clinical Practice set out in the ICH Guideline.

The updated ICH Guideline was discussed at the SCTO Forum 2025. Download the presentations here.

Health data de-identification

The de-identification of health-related data, which leads to pseudonymized or anonymized data, is in principle necessary for their transfer for re-use for research purposes, or for the sharing of such data within a multicentric research project. Swiss law does not provide specific methods or processes that are to be applied in order to de-identify health-related data. It only defines what anonymized and pseudonymized data is (i.e. coded data), and it does so on an abstract level.

The Swiss Personalised Health Network (SPHN) has developed a legally compliant methodology and a practical tool for its implementation. The Risk Assessment Tool allows project leaders to identify re-identification risks; the guide allows to select appropriate de-identification rules for the data and define contextual risk mitigation measures. The resources are available here. The use of this tool is not mandatory but is recommended by Swissethics to demonstrate that the data to be transferred is sufficiently de-identified.