Amendment to Annex I of the Clinical Trials Ordinance (ClinO) as of 1 May 2017
The international "Guideline for Good Clinical Practice" of the International Harmonisation Conference (the ‘ICH-GCP guideline’) is referred to in the Clinical Trials Ordinance of 20 September 2013 (ClinO) in Annex I, and is therefore immediately applicable in Switzerland to clinical trials of medicinal products and transplant products.
The previous ICH-GCP Guideline of 10 June 1996 was amended by the International Harmonization Conference on 9 November 2016. The aim of these amendments is to improve the management and monitoring of clinical trials by the sponsor. Particular attention is paid to protection of human subjects participating in trials and the integrity of clinical trial data.
Annex I of the Clinical Trials Ordinance refers to the amended ICH-GCP Guideline of 9 November 2016 (‘ICH E6 (R2)’) as of 1 May 2017. As of this date, the amended ICH-GCP Guideline for clinical trials with medicinal products and transplant products is applicable in Switzerland.
Link to ICH E6(R2) Integrated Addendum
Link to ClinO