EMA has published an eight-page overview of its key recommendations during 2018 on the authorization and safety monitoring of human drugs. EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 84 medicines for marketing authorization. Of these: • 42 had a new active substance not previously authorized in the EU • 21 were orphan medicines, and • three were for rare diseases. During the year, EMA approved four drugs under accelerated assessments and three under exceptional circumstances.
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