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.
Human Clinical trials Regulatory and procedural guidance Research and developmentOn 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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:
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.
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:
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:
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/618888/2022English (EN) (475.04 KB - PDF)
First published: 10/02/2023 Last updated: 15/02/2023Under 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:
