EMA assesses clinical data initiative one year on

One year ago, the European Medicines Agency (EMA) became the first regulatory authority to give open access to clinical data submitted by companies in support of their marketing authorization 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) website. 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 programs and ultimately benefitting innovation.

In a recent survey  of web users to evaluate implementation of the policy, three quarters of responders agree that the proactive publication of clinical data helps the EMA to build public trust and confidence in its scientific and decision-making processes. Two thirds of responders agree that the data made available helps researchers to re-assess the clinical data.