Posted by Michael Wonder on 20 Oct 2017
Unparalleled access to clinical data - one year on
20 October 2017 - Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback.
One year ago today, the EMA became the first regulatory authority to give open access to clinical data submitted by companies in support of their marketing authorisation applications.
EMA’s flagship policy on the publication of clinical data enables citizens, including researchers and academics, to directly access the clinical reports underpinning the regulatory evaluation of a medicine’s clinical efficacy and safety via its clinical data publication (CDP). This facilitates the independent re-analysis of data after a medicine has been approved and enhances scientific knowledge. Increased transparency facilitates knowledge sharing, leading to more efficient medicine development programmes and ultimately benefitting innovation.
