Opening up clinical data on new medicines

EMA

20 October 2016 - EMA provides public access to clinical reports.

As of today, the EMA gives open access to clinical reports for new medicines for human use authorised in the European Union.

Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said "Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available. EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation - which foresees additional milestones towards transparency, becomes applicable."

For every new medicine, citizens, including researchers and academics, will be able to directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing-authorisation applications. Clinical reports give information on the methods used and results of clinical trials conducted on medicines. EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

Read EMA press release

Michael Wonder

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Michael Wonder