EU Clinical Trials Regulation 31.Jan.2023

EU Clinical Trials Regulation 31.Jan.2023

European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into force from 31 January 2023. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. 

The EU Clinical Trials Regulation (EU CTR) repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU until the Regulation’s entry into application.

On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications and will serve as the single-entry point for submission by sponsors and for regulatory assessment.

Consult the Regulation:

See more details on EMA website, link.  

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