The European Medicines Agency (EMA) announced that the clinical trial EU Portal and Database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation by 31 January 2022. (The CTIS was originally expected in September 2018 but a series of delays have pushed back the launch). “The implementation of the Clinical Trial Regulation and CTIS will increase efficiency in the registration, conduct and supervision of clinical trials in the EU, particularly those taking place in multiple Member States, while ensuring utmost transparency for the public. This is one of the most complex and ambitious IT developments carried out by EMA…” said Christa Wirthumer-Hoche, chair of EMA’s Management Board.
April 22, 2021