New European clinical trials regulation is under way to harmonise and streamline the processes for application and supervision of clinical trials in the EU


On 25 January, the European Medicines Agency (EMA) published a press release on the new Clinical Trials Regulation (Regulation (EU) No 536/2014), coming into application on 31 January 2022. This Regulation will replace the existing EU Clinical Trials Directive 2001/20/EC and national legislation that was put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation. The new Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU via a Clinical Trials Information System (CTIS). This new portal will be the single-entry point for the submission of data and information relating to clinical trials in the EU.

EMA sets up and maintains CTIS, in collaboration with the Member States and the European Commission. Information stored in CTIS will be publicly available for transparency. In the past, sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial, and registration and posting of results were also separate processes. With CTIS, sponsors can now apply for authorisations in up to 30 EU countries at the same time and with the same documentation. The application of the Clinical Trials Regulation and the go live of CTIS will strengthen Europe’s position as an attractive location for clinical research.