Unparalleled access to clinical data – one year on

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) website.

As of 20 October 2017, clinical reports on 50 medicines, including orphan, biosimilar and generic medicines, as well as medicines for use in children, are publicly available on the CDP website. 62% of responders in EMA’s survey say that the data are useful and 87% say the data are presented in an understandable format.

See the EMA’s one year review here.

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Published 21. October 2017 in News EU