European Medicines Agency Watch [to 21 June 2014]

European Medicines Agency Watch [to 21 June 2014]

:: Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014
As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation. Under these frameworks, since the result-related information is fed into the publicly accessible European Union Clinical Trials Register, summary results of clinical trials will become available to the public as sponsors start to comply with their legal obligations….