Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and supervision processes for clinical trials in the European Union.
The backbone of the changes brought about by the clinical trial regulation is the new Clinical Trials Information System (CTIS).
CTIS is a single entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data which includes a public searchable database for healthcare professionals, patients and the general public.
