Regulatory harmonization of clinical trials in the EU
28.01.2022 10:06
On January 31, 2022, the Clinical Trials Regulation (CTR) will come into force, harmonizing the submission, assessment and monitoring procedures 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 access point for clinical trial sponsors and regulators to submit and evaluate clinical trial data, comprising a publicly searchable database for healthcare professionals, patients and the general public.
In the past, sponsors had to submit clinical trial applications separately to the relevant national authorities (NCAs) and ethics committees in each country to obtain regulatory approval to conduct a clinical trial, and registration and publication of results were also separate processes. With CTIS, sponsors can now apply for approval in up to 30 EU/EEA countries at the same time and with the same documents. The publication of study information is integrated into the system.
The application of the CTR and the commissioning 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 monitoring of clinical trials and their public registration: all sponsors of clinical trials will use the same system (CTIS) and follow the same process to request approval of a clinical trial, regardless of where they are located and with which NCA or Ethics Committee they are dealing with. The new system features a dedicated secure workspace for study sponsors to apply and manage their clinical trial applications. There is a similar secure workspace for permitting authorities, who can easily interact with the sponsor and quickly collaborate and share information with other authorities.
Because transparency is a key feature of the CTR, CTIS also includes a searchable public website that is expected to contain detailed information and results of all clinical trials approved through the system.
The CTR provides for a three-year transition period. Member States will start working in the CTIS immediately after the system becomes operational. For one year, until January 31, 2023, clinical trial sponsors can still choose to submit an initial clinical trial application under the current system (Clinical Trials Directive) or via CTIS. From January 31, 2023, the submission of initial clinical trial applications via CTIS is mandatory and until January 31, 2025, all ongoing trials approved under the current Clinical Trials Directive will be governed by the new regulation and must be submitted to CTIS be converted.
The approval and supervision of clinical trials is the responsibility of the EU/EEA member states, while the European Medicines Agency (EMA) is responsible for maintaining the CTIS. The European Commission (EC) monitors the implementation of the Clinical Trials Regulation.
Acceleration of clinical trials in the EU (ACT EU)
Building on the use of CTR and CTIS, the European Commission, the heads of medicines agencies and the EMA also launched the Accelerating Clinical Trials in the EU (ACT EU) initiative in January 2022, which aims to improve the way clinical trials are initiated, designed and carried out. The aim is to further develop the EU as a focus for clinical research, to promote the development of high-quality, safe and effective medicines and to better integrate clinical research into the European healthcare system.
ACT EU will strengthen the European clinical trial environment while maintaining the high levels of protection for trial participants, data robustness and transparency that EU citizens expect. ACT EU's ten priority actions for 2022/2023 include enabling innovative trial methods, establishing a multi-stakeholder platform and supporting the modernization of good clinical practice.
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