EMA Releases 2016 Highlights

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The agency published an overview of marketing authorizations made in 2016.

On Jan. 17, 2017, the European Medicines Agency (EMA) published an overview of the market authorizations and the safety monitoring recommendations the agency made in 2016. EMA recommended 81 drugs for market authorization in 2016, which included 27 new active substances.

Some notable highlights from the report include 16 orphan drug designations in 2016. These drugs treat patients with hematology disorders, cancer, hepatology disorders, immunological problems, and metabolism disorders. There were also accelerated assessments made for authorization of treatments for unmet needs including different forms of cancer and chronic hepatitis C infections.


Source: EMA