QRM Process / Generic

Drug Makers Appeal German Drug Suspensions

Dec 16, 2014

WSJ

Several drug makers -- including Stada, Heumann Pharma and Dr. Reddy’s Labs -- have appealed a decision by German regulators to suspend approval of generic drugs over concerns about clinical trials that were conducted by India's GVK Biosciences.

The appeal comes after regulators in France, Germany, Belgium and Luxembourg suspended the marketing approval of 25 generic drugs due to concerns over data quality from clinical trials conducted at a GVK facility in Hyderabad, India.

The drug makers that filed the appeal will be allowed to resume sales of the suspended drugs until their appeals are either approved or dismissed, a spokesman for Germany's the Federal Institute for Drugs and Medical Devices told news sources.

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