Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback

One year ago today, 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 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) websiteExternal link icon. 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.

Patients and healthcare professionals can find out more about the data supporting the approval of medicines they are taking or prescribing.


Unparalleled access to clinical data – one year on