Countdown to launch of Europe’s new clinical trials system

The clock is ticking down to the ‘go-live’ date for the EU’s new Clinical Trials Information System (CTIS) which will roll out on 31 January 2022. The European Commission formally began the countdown when it confirmed that the clinical trial EU Portal and Database – a key component of the CTIS – is ready to go.

The European Clinical Trials Regulation aims to harmonise the submission, assessment and supervision processes for clinical trials throughout the EU. The CTIS will allow the streamlining of these processes, ensuring the EU remains an attractive region for clinical research, according to the European Medicines Agency (EMA) – the bloc’s drug watchdog.

The new CTIS will become the single entry point for clinical trial application submission, authorisation and supervision in the EU, and in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Currently, sponsors must submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. With CTIS, sponsors can apply for clinical trial authorisation in up to 30 EEA countries with a single application.

Under the new Clinical Trials Regulation, there will be a three-year transition period for transitioning to the CTIS. In the first year after its launch in January 2022, applicants can still choose whether to submit their application to start a clinical trial according to the current system (Clinical Trials Directive) or according to the Clinical Trials Regulation.

From 31 January 2023 onward, submission according to the Clinical Trials Regulation becomes mandatory and by 31 January 2025, all ongoing trials approved under the current Clinical Trials Directive will need to transition to the new Regulation and to CTIS.

While the authorisation and oversight of clinical trials is the responsibility of Member States, EMA will maintain the system. EMA has created an extensive training programme to help clinical trial sponsors, national competent authorities and ethics committees prepare for using CTIS.