EC Wants Single Portal for Clinical Trial Submissions

Sponsors would submit one clinical trial application in the EU via a single portal, under a streamlined assessment process advocated by the European Commission (EC). Currently, drugmakers must submit an application to each EU country where the trial is to be conducted. This leads to “hundreds of thousands of pages of documentation” to national authorities, even for small clinical trials, said John Dalli, head of the EC’s Directorate General for Health and Consumer Policy.
Clinical Trials Advisor