Ireland’s HPRA opened a new COMBINE trial scheme channel for drug-device studies, allowing sponsors to seek authorization for combined clinical investigations through a coordinated procedure. The regulator said participation is intended to reduce administrative burden, streamline authorization, and accelerate patient access. HPRA stated that stage 2 is now open to firms testing drugs in combination with medical devices, as well as those developing advanced therapies. The scheme is designed to handle duplication between the EU’s Clinical Trials Regulation framework and medical device regulations. For biotech and medtech partnerships, the change offers a more unified regulatory route for combination evidence generation in early clinical settings.