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Essential Considerations for a Successful Submission under EU CTR

The European Union Clinical Trials Regulation (EU CTR), which came into force in January 2022, was the biggest change to EU medicinal product legislation since 1995 when the European Medicines Agency (EMA) and the centralised procedure for marketing authorisations were introduced.

The EU CTR presents fundamental changes for clinical trials in all 30 countries of the European Union (EU) and the European Economic Area (EEA). The legislation has replaced the EU Clinical Trials Directive (EU CTD) and established a consistency-centred approach for clinical trial applications, assessments, and reporting. A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions. CTIS enables harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.

Submitting Applications Through CTIS

CTIS is the single-entry point for submitting, assessing, authorising, supervising, and reporting a clinical trial in all Member States of the EU/EEA. Through CTIS, applicants can submit a single, integrated clinical trial application dossier that covers all clinical trial applications submitted to EU/ EEA Member States, national regulatory agencies and ethics committees. Through this single application, CTIS users also register their clinical trials in a public register.

The introduction of CTIS was the most significant hurdle for the introduction of the EU CTR. The journey towards this introduction has not been without challenges. Due to its pivotal role in the EU CTR process, delays to the release of CTIS led to multiple postponements of the overall introduction of the EU CTR. However, since the launch of CTIS on 31 January 2022, there have continued to be technical issues with the system – some more problematic than others. For example, some of the technology workflows have not acted as they are described. In some cases, this meant a resubmission was needed, even though the reporting member state (RMS) and sponsor had followed all the correct processes. This was a technical glitch that could not be passed. Even though the RMS wanted to progress the application to the next step, it was not possible due to the CTIS technology workflow.

The difficulties with the CTIS portal have been experienced by all users, including sponsors, regulatory agencies, and ethics committees. As a result, some countries have set-up CTIS specific working groups across sponsors, CROs, sites, etc., so that they can exchange training, learnings, and workarounds.

To resolve the portal issues experienced by users, there are regular CTIS updates being released and more information about these is published in the CTIS Newsflash, currently released weekly. It is important for all CTIS users to stay up to date on the new releases and workarounds since these can be critical to the success of an application.

Preparing for EU CTR Submissions

When planning for submission under the EU CTR in any EU/ EEA country, there are a number of prerequisites for managing studies in CTIS that sponsors should consider. Access to CTIS requires a high-level administrator to manage and assign roles within the system. Sponsors must ensure the correct users/ access rights are in place for CTIS activities to take place. Contract research organisations (CROs) are able to provide CTIS administration and submission support services to sponsors.