Qualification of Novel Methodologies ( QoNM ) has moved beyond its old role as a specialist regulatory procedure. It is becoming one of the clearest signals of how Europe intends to judge AI tools, imaging methods, mechanistic models and other next-generation evidence instruments in drug development.   For years, the EMA’s Qualification of Novel Methodologies process was easy to leave to specialists. It sat in the part of the regulatory map reserved for biomarkers, technical