European Medicines Agency’s Clinical Trials Regulation Takes Effect

January 25, 2022—The European Medicines Agency (EMA) announced that the Clinical Trials Regulation (CTR) will come into application on January 31. The CTR is intended to harmonize the submission, assessment, and supervision processes for clinical trials in the European Union (EU).

According to the EMA, the backbone of the changes brought about by the CTR is the new Clinical Trials Information System (CTIS), which is a single entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data, including a public searchable database for health care professionals, patients, and the general public.

CTIS will go live on January 31, 2022, at 9:00 AM Amsterdam time (CET). The secure workspaces of CTIS and the public searchable database will be accessible via a new clinical trials website. The URL of this website will be publicized through EMA channels, including social media and the EMA website, on January 31.

The EMA noted that sponsors previously 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. Registration and posting of results were also separate processes.

With CTIS, sponsors can now apply for authorizations in up to 30 European Economic Area countries (EEA; the EU plus Iceland, Liechtenstein, and Norway) at the same time and with the same documentation. Publication of the trial information is built in the system

The EMA stated the application of the CTR and the initiation of CTIS in the EU/EEA 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. With CTIS, all clinical trial sponsors will use the same system and follow the same process to apply for the authorization of a clinical trial, no matter where they are located or which NCA or ethics committee they are dealing with.

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 authorizing authorities, who can easily interact with the sponsor and quickly collaborate and exchange information with other authorities.

According to the EMA, transparency is a major feature of the CTR; therefore, CTIS includes a searchable public website that will prospectively contain detailed information on, and outcomes of, all clinical trials authorized through the system.

The CTR foresees a 3-year transition period. Member States will work in CTIS immediately after the system has gone live. For 1 year, until January 31, 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 January 31, 2023, submission of initial clinical trial applications via CTIS becomes mandatory, and by January 31, 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 authorization and oversight of clinical trials is the responsibility of EU/EEA Member States, while the EMA is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the CTR.

Finally, the EC, the Heads of Medicines Agencies, and the 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. According to the EMA, 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 better integrate clinical research in the European health system.

ACT EU will strengthen the European environment for clinical trials, while 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 multistakeholder platform, and supporting the modernization of good clinical practice, advised the EMA.