EU Accelerated Assessment Tracker

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.

Two new requests came before the CHMP for a decision in January 2020, relating to dostarlimab from GlaxoSmithKline and crisantaspase, from an unknown sponsor*. Also see "GSK: Please,...

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