European parliament reaches provisional agreement on new rules for clinical trial authorization procedures.

The lowdown: The European Clinical Trials Directive was introduced in 2001 to harmonize clinical trial authorization procedures across Europe, but it failed miserably and is thought to have contributed to a decline in the number of trials carried out in Europe (trials fell by 25% from 2007 to 2011, according to one analysis). In a bid to fix an overly bureaucratic and slow process, the European Commission unveiled a new regulation in July 2012 to streamline clinical trial authorization (Nature Rev. Drug Discov. 11, 660–661; 2012). After a year and a half of negotiations with stakeholders, the European Union's Permanent Representatives Committee has approved a compromise agreement.

The regulation smoothes the trial application process such that sponsors will submit their trial requests through a single portal. A single authorization procedure will also be put in place across all EU member states. Under the terms of the compromise, trial applications for standard therapies must be reviewed within 60 days, and applications for complex medicinal products must be reviewed within 110 days. These are up from original proposed review deadlines of 48–79 days. Companies will also have to submit the results of all European studies to a publicly accessible database, a move brought on by calls for greater transparency in drug development.

The agreement now needs to be authorized by the Council of Ministers and the European Parliament plenary, and could be finalized before May.