Clinical trials in human medicines are studies carried out in human volunteers intended to investigate the safety or efficacy of one or more investigational medicines.
Clinical trials can only be started after a compound has passed rigorous pre-clinical development whose findings show that the compound or the treatment is likely to be safe and will work in people.
Developing a medicine takes an average of 12 years before being approved for use in patients. Clinical research is an essential part of the development process, however it is also long and expensive.
According to the European Medicines Agency (EMA), in the EU / EEA approximately 4,000 clinical trials are authorized each year.
Approximately 60% are sponsored by the pharmaceutical industry and 40% by non-commercial sponsors, mainly academia, often small and nearly all mono-national.
In the European Union (EU) / European Economic Area (EEA), the approval of clinical trial applications is the responsibility of the national competent authorities and the ethics committee.
EU Member States and EEA countries rely on the results of clinical trials to reach their opinions on the authorization of medicines (national procedures).
The current environment for clinical trials is very demanding. Recent events including the COVID-19 pandemic and the war in Ukraine present substantial new challenges.
The way clinical trials are conducted in the EU has undergone a major change when the EU Clinical Trial Regulation (CTR) (Regulation (EU) No 536/2014) entered into application on 31 January 2022.
The main goal of this regulation is to create an attractive and favorable environment for carrying out clinical researchin the EU by harmonizing submission, assessment, and supervision processes for clinical trials in the EU. This is achieved through the Clinical Trials Information System (CTIS), the single entry point for submitting clinical trial information in the EU and the EEA.
To facilitate the transition to the new regulation, a period of 3 years is foreseen until 31 January 2025:
- Until 31 January 2023, clinical trial applications may be submitted under the old Clinical Trials Directive or under the new Regulation through CTIS.
- From 31 January 2023, all new applications for clinical drug trials must be submitted through CTIS under the Clinical Trials Regulation (CTR)
- From 31 January 2025, only the Clinical Trials Regulation will apply and all clinical trials will have to switch to the new system.
Accelerating Clinical Trials in the EU (ACT EU):
The ACT EU initiative aims to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.
The ACT EU workplan sets out deliverables and timelines for the project from 2022 to 2026 (updated on 30/08/2022).
Deliverables for 2023:
- Establishing a process to support academic sponsors in enabling large multinational clinical trials
- Supporting clinical trial sponsors to make best use of CTIS and CTR training activities
- Setting up a multi-stakeholder platform to facilitate dialogue between clinical trial stakeholders
- Modernizing Good Clinical Practices by supporting the adoption and implementation of revised EU guidelines inclinical trial design
- Facilitating innovation in clinical trial methods by publishing a methodology roadmap and providing guidance on decentralized clinical trials
What are EMA’s key roles in clinical trials?
- Developing the EU as a competitive center for innovative clinical trials
- Maintaining IT systems for the coordination of clinical trials
- Reviewing clinical data trial for EU-wide marketing authorization applications
- Co-leading the programme Accelerating Clinical Trials in the EU (ACT EU), together with the Heads of Medicines Agencies (HMA) and the European Commission (EC)
For more information, see: