Margrete Auken

MEP, shadow rapporteur, clinical trials regulation

Margrete Auken has been a Member of the European Parliament since 2004. She represents the Danish Socialist People’s Party (SF) and sits in the Greens/European Free Alliance Group in the European Parliament.

She was the shadow rapporteur in Parliament on the clinical trials regulation on medicinal products for human use, which was adopted in April 2014 and will be applied by mid-2016. The regulation focuses on improving the environment for conducting clinical trials through the simplification of current rules featuring:

- a ‘one-stop’ portal and database for submitting applications,

-a quick and flexible assessment procedure,

-a simplified reporting system,

- clearer, simpler rules for running multinational trials.

On the issue of transparency, the regulation provides for greater transparency concerning clinical trial data and results, in order for all future clinical trials in Europe to be eventually made publicly accessible online.