Clinical Trials Regulation

On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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

A transition period applies to clinical trial submission under the Regulation.

Consult the Regulation:

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

• Clinical Trials Information System

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.

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

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 will need to comply with the Clinical Trials Regulation and their sponsors must have recorded information on them in CTIS.

EMA encourages sponsors to use the transition period to ensure their information on clinical trials is recorded in CTIS in a timely manner. 

Guidance is available from the European medicines regulatory network on the CTIS website to support sponsors with transitioning their ongoing trials to CTIS:

• Clinical Trials Information System: Guidance and Q&As: Transitioning trials

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.

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