Ebola outbreaks: a stress test of the preparedness of medicines regulatory systems for public health crises.

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 crisis and protect global health. Teaser How much have we learned from the regulatory response to Ebola outbreaks and how has it contributed to shape the preparedness of regulatory systems to manage current and future public health crisis?