The Clinical Trial Information System went live on January 31, 2022, which began the one-year transition period for all clinical trial sponsors. Clinical trial sponsors are still free to decide whether to submit an initial clinical study application via CTIS in compliance with the Clinical Trials Directive or according to the Clinical Trials Regulation during the transition period. Use of CTIS will be required starting on January 31, 2023.
The Clinical Trials Regulation, which modifies how clinical trial applications are submitted, authorised, and overseen in the EU, is being implemented with the use of the Clinical Trials Information System (CTIS). All stakeholders’ practises must change significantly as a result of the Clinical Trial Regulation’s rules, which necessitate efficient change management.
The system has caused issues for certain users. By the time usage of the system becomes required for all new applications, EMA will have collaborated extensively with Member States, the European Commission, and other stakeholders to enhance the CTIS user experience for core CTIS procedures. To accomplish this, the agency has committed more resources.
To make the transition to the new system easier for sponsors and other stakeholders, EMA is collaborating closely with national appropriate parties in the Member State and the European Commission. The training materials are updated frequently to meet information demands and are accessible to assist sponsors in submitting information on their clinical trials, including their applications for clinical trial authorization. In order to explain the system, hear participants’ complaints, and provide solutions, EMA hosts frequent training webinars with sponsors.
Introduction
A clinical trial is a study carried out to look into the security or effectiveness of a drug. These investigations are conducted on willing subjects when it comes to medications meant for human use.
The Clinical Trials Regulation (Regulation (EU) No 536/2014), which took effect on January 31, 2022, governs clinical trials in the EU and EEA. It is a part of a larger effort to improve the environment for clinical trials in the EU and EEA in order to facilitate sizable trials across several European nations for the benefit of patients and medical innovation. The regulation of clinical trials seeks to guarantee the preservation of the rights, safety, and wellbeing of clinical trial participants as well as the validity and usefulness of the trials’ findings.
Applying for permission to conduct a clinical trial anywhere in the EU/EEA, including in numerous nations, updating national regulators about a trial, and submitting trial results are all possible using the website by clinical trial sponsors.
It can be used by national authorities in the EU and EEA to review clinical trial applications cooperatively, seek additional data, approve or reject a trial, and monitor an approved trial. Beginning on January 31, 2022, anybody can use it to examine data on clinical trials conducted in the EU and EEA.
The Clinical Trials Information Technology, the system supporting the website, is used by clinical trial sponsors and national regulators from the EU/EEA.
On January 31, 2022, the Clinical Trials Information System was introduced by the EU Member States, EEA nations, the European Commission, and the EMA. This webpage was launched by EMA on the same day. Together with the EEA nations, EU Member States, and European Commission, EMA manages this website.
Safe Work Areas
Through the secure Sponsor workspace and Authority workspace, this website enables the business operations of clinical trial funders and national regulators throughout the course of a clinical trial. To access these protected workspaces, users must log in.
Through a single application on this website, clinical trial sponsors can request authorization to conduct a clinical trial in up to 30 EEA nations. Additionally, they have the ability to record trial outcomes and communicate with national regulators while a trial is in progress. Using this platform, national regulators from many nations can collaborate on the evaluation and authorization of a clinical trial.
They can collaborate on clinical trial oversight using this website and other tools, including monitoring and evaluating safety-related information in the context of a clinical trial.
Legal Foundation
The purpose of the regulation is to create a conducive environment for conducting clinical trials in the EU, to ensure that the EU remains an appealing region for clinical trials, with the highest safety standards for participants and transparency of information. The Clinical Trials Information System, the system underlying this website, serves to implement EU pharmaceutical law in the
By harmonising the submission, evaluation, and oversight procedures for clinical trials supported by this website, it achieves this. Before the advent of this website, sponsors needed to apply for regulatory authorisation to undertake a clinical trial independently to the national competent authorities and regulatory agencies in each country.
On January 31, 2022, the Clinical Trials Information System was introduced by the EU Member States, EEA nations, the European Commission, and the EMA. This webpage was launched by EMA on the same day. Together with the EEA nations, EU Member States, and European Commission, EMA manages this website. The EU Member States and EEA nations are in charge of evaluating, authorising, and overseeing clinical studies.
Transitional Phase
By using the Clinical Studies Information System beginning on January 31, 2022, EU Member States and EEA nations will fulfil their legal obligations under the Clinical Trials Regulation to evaluate and monitor clinical trials.
Up until January 30, 2023, sponsors of clinical trials have the option of applying to begin a trial under the Clinical Trials Directive or the Clinical Trials Information System. Clinical trial sponsors will have to use the Clinical Trials Information System to submit an application to begin a clinical study starting on January 31, 2023.
By the end of 2025, all ongoing trials that have received approval under the Clinical Trials Directive will be subject to the Regulation, and data must be uploaded into the Clinical Trials Information System.
