As part of the COMBINE programme, the European Commission and EU Member States have launched a pilot project to test a new, more efficient way of approving combined studies. These studies involve both clinical trials of medicines and performance studies of medical devices.
This pilot is designed to allow sponsors of combined studies to submit a single application, ensuring more harmonised interactions with the Member States involved. This approach is expected to reduce the administrative burden for sponsors and promote transparency and consistency in the assessment process.
The pilot will accept a limited number of studies where the same sponsor is testing a medicine and a companion diagnostic at the same time. The aim is to see how well this new process works and to learn from the experience.
For more information and to apply for the pilot COMBINE coordinated assessment procedure, please visit the European Commission's website.
COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.
