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New system for EU clinical trial applications introduced

Posted on the 31st January 2023

Clincial Trials EU

The Clinical Trials Information Systems (CTIS) has become mandatory for new clinical trial applications in the European Union.

From 31st January 2023, all initial clinical trial applications in the EU must be submitted through the CTIS, which has become the single-entry point for clinical trials’ regulators and sponsors for the submission and assessment of clinical trial data.

The change follows a one-year transition during which sponsors could choose to apply for new clinical trials in the EU/EEA in line with the Clinical Trials Directive, or under the new Clinical Trials Regulation (CTR) which entered into application on 31st January, 2022.

Previously, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each country, in order to gain the regulatory approval necessary to run a clinical trial. Registration and the posting of results were also separate processes.

However, with CTIS, sponsors can apply for authorisations in up to 30 EU/EEA countries at the same time, and with the same documentation. The system comprises a searchable public database for patients, healthcare professionals, and other interested parties.

The CTR foresees a three-year transition period: by 31st January 2025, all ongoing trials that were approved under the Clinical Trials Directive will have to be transitioned to CTIS.

The application of the CTR renders Europe a more attractive location for clinical research. The new regulation also strengthens the processes for clinical trials’ supervision, application, and public registration, as all clinical trial sponsors, regardless of location, will now use the same system and follow the same procedures to apply for clinical trial authorizations.

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