The Regulatory & Ethical Database, RED, is here to guide you through the clinical research national regulatory and ethical landscape
Quick User guide
With this tool, you can find the relevant information to support your clinical research for various study types: Investigational Medicinal Product, Medicinal Device, and Other (for observational studies, cohort studies, etc). The results are available for a range of European countries. Instead of looking into countries one at a time, you may also compare two directly.
If you are looking for information on a vaccines or a specific population (paediatric, pregnant/breastfeeding women, elderly, etc) initially select the study type of interest and search. You will then be prompted to search by country but also by specific population.
You can also peruse some interesting resources to improve your understanding of the applicable regulations as they apply to clinical studies in Europe, and notably: CTR (Regulation (EU) No 536/2014) - CTIS, MDR (Regulation (EU) No 2017/745), IVDR (Regulation (EU) No 2017/745).
Clinical Trial Regulation (CTR)
The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. It repeals the directive 2001/20/CE in force since 2004. The CTR is directly and equally applicable in all EU countries.
The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries.
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 a single site or across 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.
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.