The European Medicines Agency argued that drug developers should prioritize generating robust evidence rather than adhering to a fixed trial-count standard. In an editorial, EMA executive director Emer Cooke and colleagues pushed back against a rigid “one pivotal study” default, saying it could undermine the goals of clinical development. The agency’s position comes as the FDA has adopted a “one pivotal study” policy and revised guidance on evidence generation, amid earlier debate over the burden and cost of requiring multiple studies. EMA said replication of identical trials is not the primary utility of multiple trials. Instead, EMA emphasized that additional trials can test effects in different populations and settings—expanding evidence rather than merely repeating results. The editorial’s framing suggests regulators want flexibility tied to evidence quality, not a numerical checklist. For biotech teams, the message is practical: regulatory strategy should be built around defensible evidentiary packages that address uncertainties, not on minimizing study numbers at all costs.