Clinical Trials Regulation

European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. 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.

On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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.

Consult the Regulation:

• Clinical Trials Regulation (Regulation (EU) No 536/2014)

Also on this topic

• Clinical Trials Information System
• Clinical Trials Regulation: progress on implementation

Aims and benefits

The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. 

The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries. 

Prior to the Regulation, clinical trial sponsors had 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 Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials. 

The Regulation also makes it more efficient for EU Member States to evaluate and authorise such applications together, via the Clinical Trials Information System.

The purpose is to foster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries. 

Other key benefits of the Regulation include:

• improving information-sharing and collective decision-making on clinical trials;
• increasing transparency of information on clinical trials;
• ensuring high standards of safety for all participants in EU clinical trials.

Clinical Trials Information System

Under the Regulation, clinical trial sponsors must submit all new clinical trial applications in the Clinical Trials Information System (CTIS) from 31 January 2023. National regulators in the EU Member States and EU/EEA countries also use CTIS. 

The system:

• enables sponsors to apply for clinical trial authorisation in up to 30 European countries with a single online application;
• allows national regulators to collaboratively process clinical trial applications in more than one country, request further information, authorise or refuse a trial and oversee an authorised trial;
• facilitates the expansion of trials to other EEA countries;
• enables transparency and access to information for any party interested in clinical trials conducted in the EEA through a searchable public website.

CTIS went live on 31 January 2022 together with the public Clinical Trials website. For more information, see: 

• Clinical Trials Information System
• Development of the Clinical Trials Information System
• Clinical Trials website

Transition period for clinical trial sponsors

Under the Clinical Trials Regulation, EU Member States and EEA countries use the Clinical Trials Information System (CTIS) to carry out their legal responsibilities to assess and oversee clinical trials from 31 January 2022:

• for the first year of implementation and until 30 January 2023, clinical trial sponsors could choose whether to apply to start a clinical trial via the Clinical Trials Information System or under the Clinical Trials Directive;
• from 31 January 2023 onwards, clinical trial sponsors need to apply to start a clinical trial via the Clinical Trials Information System;
• from 31 January 2025, any trials approved under the Clinical Trials Directive that continue running need to comply with the Clinical Trials Regulation and their sponsors must have recorded information on them in CTIS.

The European medicines regulatory network made available guidance about the transition on CTIS website. To find the guidance, see Clinical Trials Information System - Guidance and Q&As: Transitioning trials.

Questions and answers about CTIS and the Clinical Trials Regulation

EMA's Query Management Working Group prepared a document to address the main questions received from sponsor associations about CTIS and the Clinical Trials Regulation.

EMA published this document in February 2023.

Questions and answers by the Query Management Working Group on CTIS and the CTR

Reference Number: EMA/618888/2022

Progress on implementation of the Regulation

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.

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

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