Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) is mandatory

State Institute for Drug Control announces that the posting of summaries of clinical study results in the European Clinical Trials Database (EudraCT) is mandatory  

As of 21 July 2014, it is 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 2012/C 302/03, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation (Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006).

For more details please visit EMA web pages.

 

Department of Clinical Trials and Unregistered Medicines

28 July 2016