On 31 January 2022,the RegulationrepealedtheClinical Trials Directive (EC) No. 2001/20/ECand national implementinglegislation 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)
Also on this topic
- Clinical Trials Information System
Aims and benefits
TheClinical Trials Regulationharmonises the processes forassessment and supervision ofclinical 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 applicationsseparately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.
The Regulation enablessponsors to submit oneonline applicationvia a single online platform known as theClinical Trials Information System(CTIS) forapproval to run aclinical trial in severalEuropean countries, makingit more efficient to carry out such multinational trials.
The Regulation alsomakes it more efficient for EU Member Statesto evaluate and authorise such applications together, viatheClinical Trials Information System.
The purpose is tofoster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries.
Otherkey benefitsof the Regulation include:
- improvinginformation-sharing and collective decision-making on clinical trials;
- increasingtransparency of information on clinical trials;
- ensuring highstandards 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 theClinical Trials Information System(CTIS) from31 January 2023.National regulators in the EU Member States and EU/EEA countries also use CTIS.
The system:
- enablessponsors to apply for clinical trial authorisation in up to 30 Europeancountries 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 TrialsDirectivethat continue running will need to comply with the Clinical TrialsRegulation andtheir sponsors must have recorded information onthem inCTIS.
EMA encourages sponsors to use the transition period to ensure their information on clinical trials isrecorded inCTIS in a timely manner.
Guidance is available from the European medicines regulatory network on the CTIS website to support sponsors withtransitioning their ongoing trials to CTIS:
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
English (EN) (475.04 KB - PDF)
First published: Last updated:
Progress on implementation of the Regulation
Under theAccelerating 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
Related content
- Clinical Trials Information System
- Development of the Clinical Trials Information System
- Clinical Trials Information System: training and support
- Clinical Trials Information System (CTIS): online modular training programme
- Clinical trials in human medicines
- Data submission on investigational medicines: guidance for clinical trial sponsors
Related EU legislation
- Clinical Trials Regulation EU No. 536/2014
- Clinical Trials Directive (EC) No. 2001/20/EC(repealed by the Clinical Trials Regulation on 31 January 2022)
Topics
Clinical trials
Regulatory and procedural guidance
Research and development
