EU Watchdog Flags Faulty Generic Drug Data, Backs Sales Halt
Friday, July 22, 2016
The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable.
The EMA's list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd, Mylan NV and Novartis AG's Sandoz.
The recommendation comes after the U.S. Food and Drug Administration and the World Health Organization raised concerns about substitution and manipulation of patients' clinical samples by Semler Research Center Pvt Ltd.