Update of the Ordinance of Clinical Trials (ClinO) following publication of the Integrated Addendum to Good Clinical Practice (GCP)
The Swiss Federal Office of Public Health (FOPH) has commenced activities to update the Ordinance on Clinical Trials (ClinO) from September 20th 2013 following publication of the integrated addendum GCP(R2) by the international conference on harmonization (ICH) in November 2016.
The update will affect the reference to GCP in annex 1, chapter “rules and classifications”, section 2 “rules of good clinical practice”, paragraph 1.
The applicable rules of Good Clinical Practice are:
- for clinical trials of medicinal products and transplant products: the Guideline for Good Clinical Practice issued by the International Conference on Harmonisation, in the version dated 10 June 199623 (ICH Guideline);
According to FOPHs current time schedule, the revised ordinance will become effective in May 2017.