Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter into application and new Clinical Trials Information System to be launched.
On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonising the submission, assessment and supervision processes for clinical trials in the European Union (EU). The backbone of the changes brought about by the CTR is the new Clinical Trials Information System (CTIS). CTIS is a single entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data which includes a public searchable database for healthcare professionals, patients and the general public.
In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) 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/EEA countries at the same time and with the same documentation. Publication of the trial information is built in the system.
The application of the CTR and the go live of CTIS – in the EU and the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway) – will strengthen Europe’s position as an attractive location for clinical research. The new regulation streamlines the application and supervision of clinical trials, and their public registration: all clinical trial sponsors will use the same system (CTIS) and follow the same process to apply for the authorisation of a clinical trial, no matter where they are located and with which NCA or ethics committee they are dealing. The new system has a dedicated secure workspace for trial sponsors where they can apply for and manage their clinical trial applications. There is a similar secure workspace for the authorising authorities, who can easily interact with the sponsor and quickly collaborate and exchange information with other authorities.
Because transparency is a major feature of the CTR, CTIS also includes a searchable public website, that will prospectively contain detailed information on and outcomes of all clinical trials authorised through the system.
The CTR foresees a three-year transition period. Member States will work in CTIS immediately after the system has gone live. For one year, until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the current system (Clinical Trials Directive) or via CTIS. From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory, and by 31 January 2025, all ongoing trials approved under the current Clinical Trials Directive will be governed by the new Regulation and have to be transitioned to CTIS.
The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the Clinical Trials Regulation.
Accelerating Clinical Trials in the EU (ACT EU)
Building on the application of CTR and CTIS, in January 2022 the EC, the Heads of Medicines Agencies and EMA also launched the Accelerating Clinical Trials in the EU (ACT EU) initiative that seeks to transform how clinical trials are initiated, designed and run. The aim is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system.
ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect. The ten priority actions of ACT EU for 2022/2023 include enabling innovative trial methods, establishing a multi-stakeholder platform and supporting the modernisation of good clinical practice.
