Ireland’s HPRA began accepting applications for a pilot pathway that allows drug–device trial sponsors to seek combined authorization through the EU COMBINE scheme. The program is designed for studies that pair medicines with medical devices or in-vitro diagnostics, aiming to reduce duplicate paperwork and streamline timelines under separate Clinical Trials Regulation and Medical Device / IVDR frameworks. The second phase is open to sponsors running drug-in-combination-device studies and advanced therapy programs, following a first phase focused on drug plus IV diagnostic performance studies. HPRA said participation offers sponsors a coordinated assessment route and provides regulator feedback to shape future EU combined procedures. The initial monthly application slot for Phase 2 runs through late November, with COMBINE planned to operate for the next 12 months.