EMA provides public access to clinical reports

As of October 20, the European Medicines Agency has given open access to clinical reports for new medicines for human use authorized 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 the EMA in the context of marketing-authorization applications. Clinical reports give information on the methods used and results of clinical trials conducted on medicines. The EMA is the first regulatory authority worldwide to provide such broad access to clinical data.