0901 BTS8 EMAs approach

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EMA’s approach to expedited approval offers lessons for FDA

Annual check-ins with agency promote sponsor discipline, provide validation 

Annual check-ins with European regulator promote sponsor discipline and provide validation.

Sep 1, 2021 | 1:09 PM GMT

Though inspired by FDA’s accelerated approval pathway, EMA has built its system for expedited approval with a few cardinal differences that solve some pitfalls, but create other challenges, for sponsors.

In the past 15 years, the two agencies have notched roughly the same number of expedited approvals, with a marked uptick in Europe in the last three years.

EMA’s approach diverges from FDA’s in two key ways: it frames its decision as a preliminary assessment of overall benefit-risk rather than the outcome of a surrogate marker; and it places more stringent requirements on sponsors to maintain their postmarket commitments.

EMA has created tandem pathways — the exceptional circumstances pathway introduced in 1995, and conditional marketing authorization (CMA) introduced in 2006 — which differ primarily on the postmarket requirements. 

Conditional authorization carries the expectation that comprehensive data on safety and efficacy will be

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