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  • Regulatory House

Clinical Trials Regulation to enter into application and new CT Information System to be launched

On 31 January 2022, the Clinical Trials Regulation (CTR) will come into application harmonising the submission, assessment and supervision processes for clinical trials in the European Union (EU). The main change is the new Clinical Trials Information System (CTIS). With CTIS, sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. It foresees a three-year transition period. A three-year transition period is foreseen. For one year, until 31 January 2023, clinical trial sponsors can still choose whether to submit an initial clinical trial application in line with the current system (Clinical Trials Directive) or via CTIS. From 31 January 2023, submission of initial clinical trial applications via CTIS becomes mandatory.


For information see this link.

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