Ireland’s HPRA has opened application intake for the EU COMBINE pilot scheme, enabling sponsors of drug-device combination studies to seek coordinated authorization through a streamlined process. The move is intended to reduce duplicated paperwork that can delay approvals when medicines and medical devices—or in vitro diagnostics—are evaluated together. HPRA said the second phase of COMBINE covers combined clinical studies involving drugs with combination medical devices and advanced therapies. The scheme is designed to coordinate assessment across the separate regulatory frameworks that normally require distinct applications—Clinical Trials Regulation for drug components and Medical Device Regulation or IVD Regulation for device and diagnostic components. In the first phase, which started in June last year, COMBINE accepted multinational trials pairing drugs with in-vitro diagnostics. HPRA noted that eight applications were received from six sponsors in that phase, with most approved by March. The second phase is set to run for 12 months with the initial monthly application slot closing on November 23. For biotech and device partners, the practical effect is likely to be fewer administrative delays in early evidence generation for combination products.