Clinical trials are studies intended to discover or verify the effects of one or more investigational medicines.
The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial participants are protected and the results of clinical trials are credible.
Regardless of where they are conducted, all clinical trials included in applications for marketing authorisation for human medicines in the European Union (EU) / European Economic Area (EEA) must have been carried out in accordance with the requirements set out in Annex 1 of Directive 2001/83/EC. This means that:
In the EU / EEA, approximately 2,800 clinical trials are authorised each year.
Approximately 60% of clinical trials are sponsored by the pharmaceutical industry and 40% by non-commercial sponsors, mainly academia.
For more information, see Clinical Trials Regulation.
EMA's Committee for Medicinal Products for Human Use (CHMP) is responsible for conducting the assessment of a human medicine for which an EU-wide marketing authorisation is sought. As part of its scientific evaluation work, the CHMP reviews the clinical trial data included in the application.
Clinical trial data is included in clinical-study reports that form a large part of the application dossiers submitted by applicants such as pharmaceutical companies and small and medium enterprises applying for a marketing authorisation via the Agency.
Assessments are based on purely scientific criteria and determine whether or not the medicines concerned meet the necessary quality, safety and efficacy requirements in accordance with EU legislation.
Furthermore, the Agency manages two clinical trial databases, EudraCT and the Clinical Trial Information System. EMA also co-leads the business change programme Accelerating Clinical Trials in the EU (ACT EU), together with the Heads of Medicines Agencies (HMA) and the European Commission.
For more information, see Clinical Trials Regulation.
Sponsors can adjust the way they run clinical trials that have been affected by the war in Ukraine using the experience gained during the COVID-19 pandemic. They can also apply the approaches and flexibilities agreed in the context of the pandemic.
The European Commission, EMA and the Heads of Medicines Agencies (HMA) issued this initial advice for sponsors on 30 March 2022:
Additional recommendations for sponsors are available from the Clinical Trials Coordination Group (an HMA group uniting clinical trials experts):
Guidance is also available from EMA's Biostatistics Working Party on actions sponsors of affected clinical trials can take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority:
EMA strongly encourages sponsors to capture data affected and unaffected by the war, and to use the 'estimand framework' described in the ICH E9 (R1) guideline for dealing with events impacting the trial:
Guidance on clinical trial management during the COVID-19 pandemic is available below.
EMA advises sponsors to also check any guidance available at national level.
Sponsors with specific questions relating to EU guidance can contact EMA using the Send a question form. Questions relating to national guidance should be addressed to the relevant national authority.
Sponsors can also contact either EMA or the national competent authorities for scientific advice on:
EMA's Emergency Task Force (ETF) can provide support to clinical trial sponsorsfor all medicines intended to target a potential or declared public health emergency. This is in line the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).
This support includes:
Interested clinical trial sponsors should send their proposals to phesupportct@ema.europa.eu.
They should include the study protocol and specify in which Member State(s) they intend to run clinical trials, if already known.
The ETF works closely with EMA’s partner organisations in the EU to support study sponsors and the conduct of larger multinational trials.
These partner organisations include:
A report is available recommending EU-level actions to improve the set-up and conduct of clinical trials during public health emergencies.
The recommendations seek to address issues seen in the COVID-19 pandemic and outbreak of mpox disease with setting up large enough clinical trials across multiple EU Member States. These are needed to rapidly gather sufficient high-quality evidence to support decision-making by health authorities.
The report results from a lessons-learned workshop on clinical trials in emergencies held by EMA's ETF and the European Commission with national competent authorities, ethics committees and academic experts.
More information:
Guidance has been available for clinical-trial sponsors on managing clinical trials and participants during the COVID-19 pandemic:
This covered how to deal with the extraordinary situations that the pandemic presented and specific advice on clinical trials for potential COVID-19 treatments.
Guidance has also been available for sponsors of affected clinical trials to help ensure the integrity of their studies and the interpretation of the study results while ensuring the safety of trial participants:
In line with this guidance, EMA has been flexible and pragmatic during the assessment of affected clinical trial data submitted as part of marketing authorisation applications.
The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to develop the EU further as a competitive centre for innovative clinical research.
The initiative builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System's (CTIS) launch on 31 January 2022. It aims to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe.
For more information, see:
Decentralised clinical trials aim to facilitate participation in clinical trials by offering maximum flexibility and convenience.
For instance, they can enable participants to:
• have health visits at home;
• receive study medicine shipments at home;
• provide their consent electronically
The Clinical Trials Coordination Group (CTCG) is overseeing a project on decentralised clinical trials called the EU Decentralised Clinical Trials project (EU DCT project).
The project aims to identify:
• innovative designs and methodologies for clinical trials;
• opportunities provided by decentralised clinical trials in Europe;
• the challenges that decentralised clinical trials provide.
The project began in March 2022.
The project delivered a recommendation paper on the use of decentralised elements in clinical trials in December 2022.
The development of this paper took account of the perspectives of all areas of the research community on decentralised clinical trials, including at a multi-stakeholder workshop hosted by ACT EU in October 2022.
Guidance is available for clinical trial sponsors, clinicians engaged in clinical trials and marketing authorisation applicants on planning and conducting complex clinical trials:
The guidance covers the following topics:
EMA, the European Commission and the Heads of Medicines Agencies (HMA) published this guidance under the ACT EU initiative.
It aims to strengthen the link between scientific advice offered by regulators and innovative clinical research.
They published the guidance in May 2022.
For more information, see:
The Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC.
The Regulation is part of a broad initiative to transform the EU / EEA clinical trials environment in support of large clinical trials in multiple European countries, to the benefit of medical innovation and patients.
For more information, see Clinical Trials Regulation.
By 31 January 2025, any ongoing trials approved under the Clinical Trials Directive will fall under the Clinical Trials Regulation.
For more information, see:
The Clinical Trials Information System (CTIS) supports interactions between clinical trial sponsors (researchers or companies that run clinical trials and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
CTIS went live with a searchable public website on 31 January 2022.
It serves to implement EU pharmaceutical law in the Clinical Trials Regulation - Regulation (EU) No 536/2014.
For more information, see:
EMA is responsible for the development, maintenance and coordination of the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database.
The EudraCT database includes data on the following clinical trials:
Update: As of 31 January 2023, all initial clinical trial applications in the EU / EEA must be submitted through the Clinical Trials Information System.
The EudraCT database remains available for uploading the following:
From 31 January 2025, any ongoing trial in the EU / EEA will need to comply with the Clinical Trials Regulation. For more information, see Clinical Trials Regulation: Transition period for clinical trial sponsors.
A subset of this data is available through the European Union Clinical Trials Register, which EMA manages on behalf of EU and EEA Member States. Users are able to view protocol and result information regarding:
Information about the results of public clinical trials is shown in the European Union Clinical Trials Register - if published by the relevant sponsor on the EudraCT database.
In line with European Commission guideline 2012/C 302/03, sponsors are required to post results of all clinical trials in EudraCT that are completed globally.
They need to post results within 12 months of completing the trial for clinical trials in adults, and within six months for clinical trails in children.
In July 2019, EMA published a letter co-signed by the European Commission and the Heads of Medicines Agencies (HMA) reminding all sponsors of their obligation to post on EudraCT the results of completed trials:
As of June 2022, 81% of clinical trials are compliant with this requirement in EudraCT.
Between April 2019 and June 2022, the compliance rate rose:
EMA and national competent authorities enabled these compliance rates through reminders sent to clinical trials sponsors. A full list of clinical trials for which sponsors did not follow up on these reminders is available on the European Clinical Trials Register.
From October 2020, sponsors can also post results of clinical trials that ended prematurely, whether they were approved but never started or started but terminated early. Sponsors should provide the reasons for the premature end and any partial results, if available.
For more information, see the EudraCT database website.
The Agency has a separate policy on the publication of clinical reports submitted by pharmaceutical companies to support their regulatory applications for human medicines.
For more information, see Clinical data publication.
Clinical trials conducted outside the EU but submitted in an application for marketing authorisation in the EU have to follow the principles which are equivalent to the provisions of the relevant EU legislation.
For more information, see Clinical Trials Regulation.
In addition, sponsors should continue to submit information on clinical trials in EudraCT if they are:
For more information, see:
In 2012, the Agency published the final version of this paper:
This paper aims to strengthen existing processes to provide assurance that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted.
The number of clinical trials and clinical trial subjects outside Western Europe and North America has been increasing for a number of years. More information is available in this document:
The Clinical Trials Coordination Group (CTCG) is a working group of the Heads of Medicines Agencies.
The CTCG aims to help make the EU / EEA more attractive for clinical trials activities.
It is responsible for harmonising and optimising the regulatory environment while assuring the protection of rights, safety and wellbeing of clinical trial participants and ensuring the generation of robust data.
The group is composed of experts in the classification, assessment and oversight of clinical trials from national agencies.
The Clinical Trials Coordination Group replaced the Clinical Trials Facilitation and Coordination Group.
The Clinical Trials Highlights newsletter covers topics such as Accelerating Clinical Trials in the EU (ACT EU) and the development of CTIS.
Issues from July 2023 (Issue 15) onwards are available at the link below:
Previous issues are available on EMA's website in PDF format:
Use the link below to receive Clinical Trials Highlights by email: