In a globalized world, infectious diseases of international concern are inevitable. When they (re-)emerge, the regulatory system works towards mitigating their impact. Ebola outbreaks marked a turning point in regulatory preparedness and efforts led to the accelerated development of therapeutic agents, in a catastrophic environment. However, only one clinical trial determined a vaccine’s efficacy. Key lessons were considered and applied thereafter. The collaborative work resulted in the approval of the first therapeutic options against Ebola, a milestone in public health preparedness. The response demonstrated the successful implementation of regulatory mechanisms fostering development, early access and assessment of therapeutic agents, and the flexibility to embrace innovative regulatory solutions. The current system is robust to address health crises and protect global health.

在全球化的世界中，国际关注的传染病不可避免。当它们（重新）出现时，监管系统会努力减轻它们的影响。埃博拉病毒的爆发标志着监管准备工作的一个转折点，在灾难性的环境中，这些努力导致了治疗药物的加速发展。然而，只有一项临床试验确定了疫苗的功效。之后考虑并应用了重要的经验教训。合作工作导致批准了首个针对埃博拉病毒的治疗方案，这是公共卫生准备的一个里程碑。响应表明监管机制的成功实施，促进了治疗剂的开发、早期获取和评估，以及采用创新监管解决方案的灵活性。