On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and regulatory process for drug clinical trials across the EU. Prior to the implementation of the new CTR, clinical trial sponsors were required to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.


The new CTR enables sponsors to submit a single application via an online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in up to 30 EEA countries. The goal is to optimise the clinical trial process and make it more efficient to conduct pan-European trials. The regulation seeks to provide a single, unified portal and database for both trial sponsors and regulatory agencies in each member state. For sponsors, the portal will be the main platform to submit applications and notifications allowing regulators to conduct their assessments and supervise the trial. During a clinical trial, users of CTIS can collaborate with national regulators while recording the results. In addition to this, the CTIS enables the monitoring of results and assessing safety-related data in this single integrated online platform.


The CTR and CTIS aims include the implementation of clinical trial regulations, to improve the efficiency and transparency of drug clinical trials and ensure the highest safety standards for trial participants. Under the new CTR, clinical trial sponsors can use the Clinical Trials Information System (CTIS) from 31 January 2022, but are not obliged to use it immediately, in line with a three-year transition period. National regulators in the EU Member States and EEA countries will use CTIS from 31st January 2022. The Clinical Trials website can be visited here and the CTIS can be visited here where you can find out more information.


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