The ACT EU initiative aims to identify gaps, issues and bottlenecks (regulatory, resourcing, operational) that prevent non-commercial sponsors from setting up and conducting clinical trials and multinational trials in particular.
The programme intends to establish an action plan with clear measures in place to support non-commercial sponsors across the European Union / European Economic Area by:
- creating and maintaining a network of regulatory helpdesks, building on national activities, including extra support for questions on the Clinical Trials Regulation and the Clinical Trials Information System;
- finalising a definition of non-commercial sponsors;
- organising dedicated workshops, in liaison with the ACT EU Multi-stakeholder platform advisory group, to address prioritised topics.
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').
A report is available on the first six months of activities and impact of the helpdesk.
This milestone reflects ACT EU's ongoing commitment to facilitating clinical trials by non-commercial sponsors through tailored support during the submission of clinical trial applications.
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.
Fee waiver for scientific advice
EMA charges a fee for scientific advice (see EMA website: Scientific advice and protocol assistance), which varies depending on the scope of the advice.
Entities not engaged in economic activities are eligible to receive a fee waiver as of 1 January 2025.
For more information see Fee Regulation working arrangements.
Exploratory analysis on funding for academic trials
This paper outlines proposals for EU-level funding to complement existing national mechanisms and enhance the conduct of multi-national clinical trials by academic sponsors.
These proposals are put forward to EU research policy makers, including the European Commission, for consideration for funding programmes.
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. |
| ERDERA | Funding, Training | Rare diseases | The European Rare Diseases Research Alliance (ERDERA) aims to make Europe a world leader in rare diseases research and innovation. ERDERA offers several support services, including funding opportunities, training programmes and a data services hub, which are detailed on their website. ERDERA has also developed a free three-hour training course on "Management of multinational clinical trials for rare diseases" which familiarises investigators and site teams with the specific challenges of initiating and managing multinational rare‑disease trials. ERDERA launches online training on managing multinational clinical trials for rare diseases - ERDERA |
| EATRIS | European infrastructure | Translational medicine | EATRIS is the European non profit organisation for translational medicine. The research infrastructure offers a broad range of research services to translate scientific discoveries into patient benefits. |
| EJPRD Innovation Management Toolbox | Database | Rare disease translational medicine | The European Joint Programme on Rare Diseases (EJP RD) created a free to use library of resources in rare disease translational medicine to provide investigators with self-help resources. |
*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:
News
Following consultation with the Multi-stakeholder platform Advisory Group, new documents have been published to support sponsors in the implementation of the Clinical Trials Regulation (CTR).
The ACT EU workplan for 2025-2026 outlines the initiative's areas of focus, which reflect feedback from stakeholders.
ACT EU has published two new webpages with information of interest to the network and clinical trial stakeholders.
