The European Commission and the competent authorities of EU Member States have launched phase 2 of the COMBINE pilot coordinated assessment procedure for combined clinical studies, expanding the scope of eligible multinational studies involving investigational medicinal products, medical devices, in vitro diagnostic devices and Advanced Therapy Medicinal Products. Building on the first phase, the programme introduces a rolling monthly application process, allows either single or separate sponsors, and will later add a procedure for substantial modifications and explore the use of single protocols and joint documentation. The COMBINE initiative aims to improve coordination between the EU regulatory frameworks for clinical trials, medical devices and in vitro diagnostic devices, streamline authorisation procedures, reduce administrative burden and support the development of innovative combined therapies while maintaining robust regulatory oversight. Sponsors wishing to participate in the first application window, which opens in September 2026, must submit their expressions of interest by 23 August 2026.