RAPS: EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications. In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016. One of the major changes in the new Clinical Trials Regulation is increased transparency measures, which require clinical trials to be registered in a \"publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP).\"