Regulatory Harmonization of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and new Clinical Trials Information System (CTIS) to be Launched

On 25 January 2022 the EMA released the news about the CTIS launching on 31 January 2022.

On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonizing the submission, assessment and supervision processes for clinical trials in the European Union (EU). The backbone of the changes brought about by the CTR 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.

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