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On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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.
A transition period applies to clinical trial submission under the Regulation.
Consult the Regulation:
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 can use the Clinical Trials Information System (CTIS) from 31 January 2022, but are not obliged to use it immediately, in line with a three-year transition period. National regulators in the EU Member States and EEA countries will use CTIS from 31 January 2022.
- 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:
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.
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.