FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA: 30 Drugs Granted Conditional Market Authorization in the Past Decade

Jan. 31, 2017
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The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago.

Oncology, infectious disease, neurology and ophthalmology treatments were among the conditionally approved therapies. Other therapeutic areas, such as endocrinology and rheumatology, fared less favorably and were not authorized, according to the agency.

In total, the EMA received 52 applications for conditional marketing authorization, with the average number of submissions trending upward each year since 2006. A majority of the applications received approval, but about 38 percent of the submissions — or 22 — were not granted the authorization.

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