EU Clinical Trials Information System set to go live end of 2021
The EU’s Clinical Trials Information System (CTIS), a centralized portal and database for information storage foreseen by the Clinical Trials Regulation (2014), is set to go live in December 2021. The go live date was confirmed at the most recent virtual meeting of the Board of the European Medicines Agency (EMA) (11 June, 2020). In addition, board members formally endorsed methodologies for the project. The development of the CTIS has proven to be a challenging task and beset by several delays to date. The establishment of a central portal and database aims to streamline the flow of information between sponsors and EU authorities and to increase transparency.