The ACT EU initiative aims to identify gaps, issues and bottlenecks (regulatory, resourcing, operational) that present challenges for non-commercial sponsors in the conduct of clinical trials and multinational trials in particular.
The programme intends to propose pragmatic and harmonised solutions to support non-commercial sponsors setting up and conducting clinical trials across the European Union / European Economic Area.
Helpdesk for non-commercial sponsors
The helpdesk employs different measures to assist sponsors in navigating the clinical trial landscape in the European Union (EU).
Currently, the helpdesk offers tailored technical assistance on CTIS functionalities and addresses questions on regulatory requirements related to the clinical trial lifecycle. The helpdesk may also consult National Competent Authorities to provide support on specific cases.
Submit your question now by raising a ticket in the CTIS Service Desk and indicating your status as a non-commercial sponsor in the relevant field ('User affiliation').
Map of national support initiatives
The Clinical Trials Regulation aims to create a more favourable environment for the conduct of clinical research in the EU.
With input from the Clinical Trials Coordination Group (CTCG), ACT EU has identified initiatives available in each EU Member State to support non-commercial sponsors at national, EU or global level.
Other stakeholder initiatives*
The following initiatives by other stakeholders involved in clinical trials in the EU may also be of use for non-commercial sponsors.
| Name of initiative | Type of support | Focus area | Description & Links |
| Enpr-EMA | Network | Paediatrics | The European network of paediatric research at the European Medicines Agency (Enpr-EMA) is a network of research networks and centres with recognised expertise in performing clinical trials in the paediatric population. It is a platform for sharing good practices, and promotes research into medicines for children. The Enpr-EMA database includes research networks and centres with recognised expertise in performing clinical studies in children. |
| ECRIN | Infrastructure | Management of clinical studies | ECRIN, the European Clinical Research Infrastructure Network, facilitates multinational clinical research through advice and services for the set-up and management of investigator or SME led clinical studies in Europe. |
| RED | Database | Regulatory and ethical requirements in member states | ECRIN's Regulatory & Ethical Database, RED, helps users find relevant information to support clinical research for various study types. |
*EMA is not responsible for the content, accuracy, or completeness of information on external websites or services linked from this site. These links are provided for convenience, and EMA does not endorse or have control over the information or services provided by third parties.
Training for sponsors
The below materials provide an overview and instructions applicable for non-commercial sponsors using the Clinical Trials Information System (CTIS):
Related material
The ERA4Health Partnership, funded under the Horizon Europe Framework Programme, has published some relevant documents:
