The European Medicines Agency argued that drug developers should focus on generating robust evidence rather than adhering to a fixed number of clinical trials. In an editorial, EMA executives and colleagues criticized “one-trial” style default expectations as potentially undermining the goals of clinical development programs. The agency directly referenced the FDA’s evolving positions on evidence sufficiency, including a prior emphasis on “one pivotal study,” while maintaining that multiple studies can explore effects across different groups and settings. For biotech sponsors, the message is operational: trial design strategy may need to be justified by evidence quality and question coverage, not by a compliance checkbox. As regulators push for efficiency, the editorial frames the debate as a methodological one—how to ensure medicines are supported by evidence appropriate to benefit-risk assessment.