In an editorial, the European Medicines Agency argued that regulators and sponsors should prioritize generating robust evidence rather than adhering to a fixed trial count standard. EMA executive director Emer Cooke and colleagues referenced the FDA’s “one pivotal study” stance while stressing that a rigid default could undermine the goals of clinical development. The agency said multi-study programs can evaluate effects across different groups, settings, and clinical contexts beyond simple replication. The position lands amid evolving FDA guidance and continued debate on how much evidence is needed for marketing authorization, with potential downstream implications for trial design and cost.