Module 6

04 October 2024

Accelerated Assessment

• For products of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation

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What are the unmet needs?

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How the product will address them?

•

What is the strength of evidence?

• In accelerated assessment maximum active time 150 days

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Accelerated Assessment

Highlights of 5-year analysis : 2012-2017

Main reasons for rejection were : • Unmet medical need not adequately justified or not substantiated by the patient population included in the clinical programme • Data not sufficient to justify a major public health interest • No major advantages compared to available treatments • Dossier not mature enough

In 2023 three medicines received a recommendation for marketing authorization following an accelerated assessment : Abrysvo, Arexvy and Talvey

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

33

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