On 31 January 2022, the European Clinical Trials Regulation (CTR), which harmonises the procedures for the submission, assessment and supervision of clinical trials conducted in the European Union (EU), will enter into force. The basis of the changes brought about by the CTR is the new Clinical Trials Information System (CTIS). CTIS is the single entry point for clinical trial sponsors and regulators to submit and assess data for clinical trials and which includes a searchable public database for healthcare professionals, patients and the general public.
Until now, sponsors have had to submit separate applications to national competent authorities and ethics committees in each country to obtain regulatory approval to conduct a clinical trial. Registration and publication of results were also separate procedures. Through CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. The publication of trial data is integrated into the system.
The implementation of the CTR and the launch of CTIS - in the EU and the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway) - will strengthen Europe's position as an attractive area for clinical research. The new Regulation streamlines the submission and supervision of clinical trials and their public registration: all clinical trial sponsors will use the same system (CTIS) and follow the same procedure to apply for authorisation of a clinical trial, regardless of where they are located and which national competent authority or ethics committee they deal with. The new system has a dedicated secure workspace for sponsors to submit and manage clinical trial applications. There is a similar secure workspace for authorising authorities, who can easily contact the sponsor and quickly collaborate and exchange information with other authorities.
Because transparency is an important feature of the CTR, the CTIS also includes a public searchable website, which will contain detailed information and results of all clinical trials authorised through the system. Member States will work on the CTIS immediately after the system becomes operational. For one year, until 31 January 2023, applicants will still be able to choose whether to submit their application to start a clinical trial under the current system (Directive 2001/20/EC) or through the CTIS. From 31 January 2023 onwards, submission of applications via CTIS will become mandatory and by 31 January 2025, all ongoing trials authorised under Directive 2001/20/EC for clinical trials will have to migrate to the new Regulation and CTIS.
The authorisation and supervision of clinical trials is the responsibility of the EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the CTR.
AcceleratingClinicalTrialsintheEU (ACTEU)
Based on the implementation of the CTR and CTIS, in January 2022 the EC, the Heads of Medicines Regulatory Authorities (HMAs) and the EMA have additionally launched the Accelerating Clinical Trials in the EU (ACT EU) initiative which seeks to transform the way clinical trials are initiated, designed and conducted. The aim is to further develop the EU as a hub for clinical research, promote the development of high-quality, safe and effective medicines and better integrate clinical research into the European health system.
The ACT EU initiative will strengthen the European environment for clinical trials, while maintaining the high level of protection for trial participants, robust data and transparency that EU citizens expect. ACT EU's ten priority actions for 2022/2023 include enabling innovative trial methods, creating a multi-stakeholder platform and supporting the modernisation of good clinical practice.
Note
The CTIS will go live on 31 January 2022 at 9:00 am Amsterdam time (CET). The CTIS secure workspaces and searchable public database will be accessible via a new Clinical Trials website. The URL of this website will be made public by EMA on 31 January 2022.
(AF)
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