Clinical Trials Regulation: progress on implementation

Under the Accelerating Clinical Trials EU (ACT EU) initiative, the European medicines regulatory network publishes statistics on the authorisation of clinical trials in the European Union (EU) and European Economic Area (EEA) every month. This information provides an insight into how the Clinical Trials Regulation is transforming the clinical-trial environment in the EU / EEA.

The reports include information on the number of clinical trial applications submitted, as well as the number of clinical trials authorised and not authorised by national regulatory authorities.

It compares these numbers for the Clinical Trials Regulation and the Clinical Trials Directive.

The reports include a breakdown of these statistics by:

• sponsor type (commercial or con-commercial);
• whether the clinical trial is taking place in one EU Member State or in more than one;
• clinical trial phase;
• therapeutic area (the type of condition that the clinical trial is investigating).

The data in the reports come from the two EU clinical-trial databases that EMA manages on behalf of the network:

• Clinical Trials Information System(CTIS)
• European Union Drug Regulating Authorities Clinical Trials (EudraCT) database

The network began publishing these reports in May 2022.

TheClinical Trials Regulation introduced substantial changes in how clinical trials are authorised in the EU / EEA, enabling sponsors to submit a single application to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials. It came into effect on 31 January 2022. 

Sponsors may continue to choose to apply to run a clinical trial under the Clinical Trials Directive during a transition period. For more information, see Transition period for clinical trial sponsors. 

TheEuropean medicines regulatory network provides these reports under the Accelerating Clinical Trials in the EU (ACT EU) initiative. ACT EU uses this information to monitor the progress in implementing the Clinical Trials Regulation, which is a priority action of the initiative.

ACT EU consists of the European Commission, the Heads of Medicines Agencies (HMA), the Clinical Trial Coordination Group (CTCG) and EMA.