The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.