A plenary session of the European Parliament has voted to adopt the text of the Clinical Trials Regulation. This is a landmark in a process that has been ongoing for a decade, and is expected to continue for several years. The debate and vote had originally been scheduled for April 4th, but was brought forward by a day.
The legislation will streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable trials, as well as those on products for rare diseases. It simplifies reporting procedures, and empowers the European Commission to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state will have to respond to it within fixed deadlines.
“I am delighted that the overwhelming majority of MEPs backed this deal. It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe”, said Glenis Willmott (S&D, UK), who steered the legislation through the European Parliament. Her report was approved by 594 votes to 17, with 13 abstentions.
Further details can be found on the European Parliament website, and will be discussed in detail on ClinDev over the coming weeks.