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 | Link |
| 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. |
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:
