31.01.2023 : CTIS : a single-entry point for EU clinical trials
Today, January 31st 2023, the Clinical Trial Information System (CTIS) becomes mandatory as the single-entry point for the submission and assessment of clinical trial data for sponsors and regulators in the European Union (EU).
The new Clinical Trial Regulation (CTR) (EU) No 536/2014 entered into application a year ago repelling the Clinical Trial Directive (EC) No. 2001/20/EC, with the CTIS launched at this time over a one-year transition period. Prior to the new Regulation, clinical trial sponsors had to submit applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The Regulation now enables sponsors to submit one single online application via the CTIS platform in order to run a clinical trial in several European countries. The CTIS makes it more efficient to carry out multinational trials, since EU Member States can evaluate and authorise such applications together, via one single platform.
The aim of the new legislation and the CTIS is to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. As such, the CTIS also includes a public searchable database of all ongoing clinical trials in the EU and the wider European Economic Area (EEA) not only for healthcare professionals, but also for patients and the general public.
During the transition period, some users have experience problems with the system. For example, the portal did not flag or sent information to sponsors when new information was received – meaning sponsors had to frequently check for updates. As such, the European Medicines Agency (EMA) has invested additional resources to improve the CTIS user experience for core CTIS processes, hopefully resolving such technical glitches by today’s effective date.
Training materials are also available to help sponsors submit information on their clinical trial data, which are updated regularly to reflect information needs. EMA is also running regular training webinars with sponsors to explain the system and listen to their complaints, so that it can quickly address concerns. For example, multiple reports have come to light that certain Member States are requiring documents that are not specified in the CTR – which, hinders the purpose of the new regulation. EMA advises sponsors to use the CTIS support service and not be deterred.
by Catarina Carrão
Clinical Trial evaluation timelines (updated 26/01/23): https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-evaluation-timelines_en.pdf
Clinical Trial Sponsor Handbook: https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf