Clinical Trials Information System mandatory for new applications
Sponsors of new clinical trials in the European Union (EU) must now use the Clinical Trials Information System (CTIS) to submit applications. The system is the single entry point for clinical trial application submission, authorisation and supervision in the EU, and in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in line with the old Clinical Trials Directive or under the new Clinical Trials Regulation (CTR) which entered into application on 31 January 2022.
The EMA says the new system will make the clinical trials system more efficient, while industry experts hope it will make Europe a more attractive place to conduct trials.
In the past, sponsors had to submit applications separately to national authorities and ethics committees in each country to gain regulatory approval. Registration and the posting of results were also separate processes.
With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. The system includes a public, searchable database for healthcare professionals, patients, and other interested parties.