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 …
National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials …
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. The Accelerating Clinical Trials in the EU (ACT EU) initiative …