Bridging Regulatory Speed: A US–EU Perspective on Rapid Drug Approvals
Abstract
However, there is growing pressure on the regulatory community to provide life-saving drugs to patients sooner, and as such, they have come up with flexible approval processes that attempt to strike a balance between speed and sound evidence. This poster will highlight the key options available in the US and Europe. The FDA's Emergency Use Authorization allows promising drugs to be used on a temporary basis during public health crises before full data is available, while Accelerated Approval allows earlier approval for drugs based on surrogate markers that are reasonably likely to predict clinical benefit. The EMA's Conditional Marketing Authorization allows drugs to be marketed while full data is not available (with a commitment to complete studies later), while Accelerated Assessment is simply an expedited review process for drugs that address serious medical needs. These processes highlight the key differences in the degree of risk that each regulatory authority is willing to take, the amount of evidence required, and the post-approval obligations.
Conclusion: EU and US expedited approval pathways enable faster patient access to critical therapies but require strong post-approval evidence, regulatory harmonization, real-world data integration, and sustained scientific transparency to maintain safety and public trust.
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