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    On 31 January 2022, the Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States, which regulated clinical trials in the EU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

    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:

    Clinical Trials Information System

    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. 

    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: 

    Transition period for clinical trial sponsors

    Clinical trials information system - banner deadline 31 January 2023

    Under the Clinical Trials Regulation, national regulators in the EU Member States and EEA countries will use CTIS to carry out their legal responsibilities in evaluating and overseeing clinical trials from 31 January 2022. However: 

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

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