Francesca Spera -

The European Commission has confirmed that the entry into force of the Clinical Trials Regulation (EU) No 536/2014 and the go-live date for the Clinical Trials Information System (CTIS) will be on January 31st, 2022.

The Clinical Trials Regulation aims to harmonize the processes for clinical trials throughout the European Union.

Clinical Trials Information System will become the single-entry point for clinical trial application submission, authorization and supervision in the EU.

CTIS will support the coordinated assessment of safety reporting in the context of clinical trials highlighting the benefits and the risks of medicinal products and it will facilitate recruitment of trial participants. Moreover, CTIS will contain a public website with details and outcomes of all clinical trials conducted in the EU, thus improving transparency and access to information for patients, healthcare workers and other interested parties.

There will be a three-year transition period: for one year, until January 31st, 2023, applicants will be able to choose whether to submit the application according to the current system or according to the new regulation. Starting from January 31st, 2023, submission via CTIS will become mandatory and by January 31st, 2025 all ongoing trials approved under the current directive will have to pass to the new Regulation and to the CTIS.

RPN will provide any further update on this hot topic and is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments as well as for the notifications of observational studies.

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