EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

6 December 2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that have been approved on the basis of studies conducted at the GVK Biosciences site in Hyderabad, India. GVK is Asia’s leading small-molecule contract research organization.

The European Medicines Agency is currently reviewing findings of non-compliance with Good Clinical Practice at this site and determining their impact on medicines authorized on the basis of studies performed at the site. These suspensions taken at national level are precautionary measures until the review is finalized.

The EMA started the review in September 2014 following an inspection carried out by the French medicines agency at the GVK Biosciences site which raised concerns about the reliability of studies conducted at the site between 2008 and 2014.

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