Europe – Clinical Trials Information System (CTIS) highlights – June 2020

The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will bring a major change in the authorisation, conduct, supervision and reporting of clinical trials in the European Union (EU). The Regulation harmonises the submission, assessment and supervision processes for clinical trials throughout the EU via CTIS. Articles 80 and 81 assign the European Medicines Agency (EMA) to set up and maintain the information system, in collaboration with the Member States and the European Commission. CTIS will enable the implementation of the Regulation…