Drugs and Pharmaceuticals: India
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Revision as of 06:08, 12 December 2014
This is a collection of articles archived for the excellence of their content. Readers will be able to edit existing articles and post new articles directly |
This is a collection of articles archived for the excellence of their content. |
Curbs by four EU nations
December 07 2014
Four European countries decided to suspend marketing authorization of 25 drugs, which had undergone tests at the GVK Biosciences facility European Medicines Agency (EMA) did say in a statement that it is reviewing the findings of non-compliance with good clinical practice at the GVK facility and determining its impact on medicines authorized on the basis of studies performed there. Germany , France, Luxembourg and Belgium have already decided to suspend marketing authorizations of these drugs. EMA's Committee for Medicinal Products for Human Use (CHMP) is now identifying, together with member states of the EU, the medicines covered by the inspection findings. French drug regulator ANSM has said on its website that Belgium, Germany , Luxembourg and France decided to suspend the marketing authorizations for the medicinal products concerned. “Although these documents are not essential to the demonstration of bioequivalence, the ANSM decided, as a precaution, to suspend the marketing authorization of 25 marketed generic drugs.
