CTIS go-live date is today!
Clinical Trials Regulation EU 536/2014 is applied and hence the go-live date for the Clinical Trials Information System (CTIS) is today 31 January 2022.
CTIS will become 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. Currently, sponsors must submit clinical trial applications to the national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. With CTIS, sponsors can apply for clinical trial authorisation in up to 30 EEA countries with a single application. The CTIS will also, together with other EMA provided portal tools, support the coordinated assessment of safety reporting in the context of clinical trials.
The ultimate goal of Clinical Trials Regulation is to harmonise the submission, assessment and supervision processes for clinical trials throughout the EU. CTIS will uniform these processes, enabling shared process of clinical trial applications. It easy up performance of multi-centre trials in EU.
The system will facilitate recruitment of trial participants by allowing sponsors and researchers to easily expand trials to other EEA countries, and will support collaboration across borders for better results and knowledge-sharing.
The system will contain a public website with detailed information on and outcomes of all clinical trials conducted in the EU, thus improving transparency and access to information for patients, healthcare workers and others interested in clinical trials on medicine.
Medfiles’ Clinical team have done a lot of effort to be ready for this change and is ready to jump into new! Contact us if you want to use our expertise.