The single European Clinical Trials Information System (CTIS) will come into force along with EU Regulation 2014/536 on clinical trials of medicinal products for human use on January 31st, 2022, as stated by publication in the European Official Journal. To report it is a note of the European Medicines Agency (EMA) that will also be responsible of the management for the system, while the authorization and supervision of clinical trials will remain responsibility of the Member States.
EU Regulation 2014/536 aims at harmonizing the submission, evaluation and supervision processes of clinical trials across the EU.
CTIS will serve as the single access point for submission of data and information concerning clinical trials. It will also facilitate communication between Sponsors and relevant Member States and will enable cooperation among Member States when needed.
At present, sponsors must submit clinical trial applications separately to the national competent authorities and ethics committees in each country to obtain regulatory approval to conduct the trial. With CTIS, sponsors will be able to apply for clinical trial authorization in up to 30 EEA countries from a single application.
CTIS, according to EMA’s note, will facilitate enrollment of trial participants, allowing sponsors and researchers to easily extend trials to other EEA countries, and support cross-border collaboration aimed at achieving better outcomes and more effective knowledge sharing. CTIS also provides a public website containing the details and outcomes of all clinical trials conducted in the EU. In this way, all EU citizens will have access to clinical information regarding medicines. To that end, all information contained should be in a user-friendly format.
A three-year transition period is planned. Until January 31st 2023, applicants will still have the choice of applying to start a trial using the current system or the new one. From January 2023, submission under the new regulation will become mandatory, and by January 31st 2025 all ongoing trials, approved under the current directive, must switch to the new regulation and CTIS.
Di Renzo Regulatory Affairs has established a unit experienced in clinical trials of medicines and medical devices consisting of a physician and highly qualified technicians.
In the area of clinical trials, currently undergoing a major regulatory evolution, Di Renzo Regulatory Affairs is able to offer regulatory and technical assistance for:
- Interventional and observational clinical trials
- Review of documentation to be submitted to the Competent Authority and Ethics Committees
- Data entry in OsSC (National Observatory on Clinical Trials) and National Registry of Observational Studies
- Translation of dossiers, clinical protocols, informed consent, and other documentation to be included in the CTA.
Written by: Felisiano Cipressi