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 are available on the ACT EU website at the link below:

• ACT EU: Documents: Implementation of the Clinical Trial Regulation

They 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.

The Clinical 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.

Since 31 January 2023, sponsors have to submit new initial clinical trial applications via CTIS, in compliance with the Clinical Trials Regulation.

Sponsors can continue to manage their ongoing trials authorised under the Clinical Trials Directive within this legal framework. However, they will need to move to CTIS any trial expected to conclude by 31 January 2025, which marks the end of the transition period.

For more information:

• Transition period for clinical trial sponsors

The European 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. 

Implementation progress reports

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 June 2023, edition 15)

Reference Number: EMA/316137/2023

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 May 2023, edition 14)

Reference Number: EMA/268020/2023 Rev.1

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 April 2023, edition 13)

Reference Number: EMA/202385/2023

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 March 2023, edition 12)

Reference Number: EMA/174654/2023

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-28 February 2023, edition 11)

Reference Number: EMA/120619/2023

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 January 2023, edition 10)

Reference Number: EMA/77032/2023 Rev.1

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 December 2022, edition 9)

Reference Number: EMA/2/2023

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 November 2022, edition 8)

Reference Number: EMA/912178/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 October 2022, edition 7)

Reference Number: EMA/860547/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 September 2022, edition 6)

Reference Number: EMA/799170/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 August 2022, edition 5)

Reference Number: EMA/726540/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 July 2022, edition 4)

Reference Number: EMA/671663/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1 - 30 June 2022, edition 3)

Reference Number: EMA/620032/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (1 - 31 May 2022, edition 2)

Reference Number: EMA/557196/2022

Key performance indicators (KPIs) to monitor the European clinical trials environment (31 January - 30 April 2022)

Reference Number: EMA/246644/2022