January 2014 – The new legislation on research involving humans is enforced in Switzerland from January 1st 2014 as foreseen by the Human Research Act, HRA, of September 30th, 2011.
Switzerland has now implemented 3 ordinances which rule out the application of the HRA principles.

▪ Ordinance on Clinical Trials in Human Research
▪ Ordinance on Human Research with the Exception of Clinical Trials
▪ Ordinance on Organisational Aspects of the Human Research Act

The new legislation is a relevant step forward in modern human research as it introduces several innovations to the previous Ordinance on Clinical Trials (812.214.2) dated 2001. Among the major changes, there is now the possibility to have the parallel submission of a study protocol to Ethical Committee and Competent Authority, (Swissmedic). This will allow Sponsors to save approximately one month time in the approval phase compared to the previous procedure therefore; a clinical study could possibly start just after 5 weeks from the submission date.

CROss Alliance™ had an early involvement in the revision and evaluation of draft legislation and participated to Swissmedic workshops on the new regulations. Today, the team welcomes this important change in the national scenario of clinical trials regulation and is ready to face the new challenges.