What is the Origin of Expedited Review?

This regulatory mechanism was established as part of public health policy to balance the need for rigorous scientific review with the urgent need for new therapies for life-threatening or debilitating diseases. The concept originated from legislative efforts to streamline the drug approval process during public health crises and for complex diseases with limited treatment options. It formalizes a faster track for promising medical innovations.

What is the Mechanism of Expedited Review?

The designation allows for several procedural efficiencies, including close communication between the drug sponsor and the regulatory agency, the possibility of a "rolling submission" where sections of the Marketing Authorization Application are reviewed as they are completed, and shorter target review timelines. While accelerated, the mechanism maintains the high standard of requiring substantial evidence of safety and efficacy; it primarily streamlines the administrative and scheduling aspects of the review.

Expedited Review

Meaning

Expedited Review is a formal regulatory pathway provided by agencies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) to accelerate the evaluation and approval of new drugs. This designation is specifically reserved for therapies that treat serious conditions and demonstrate a clear potential to provide a significant advantage over existing treatments or address an unmet medical need. The goal is to facilitate earlier patient access to critically important medicines.