GVK Bio comes under EMA scanner

GVK Bio comes under EMA scanner
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Highlights

GVK Biosciences, a city-based contract research organization and part of GVK Group, is now under the scanner of the European Medicines Agency (EMA) for alleged non-compliance with good clinical practices at the facility owned by the company. The European health regulator has begun a review in this connection.

Hyderabad: GVK Biosciences, a city-based contract research organization and part of GVK Group, is now under the scanner of the European Medicines Agency (EMA) for alleged non-compliance with good clinical practices at the facility owned by the company. The European health regulator has begun a review in this connection.

The EMA’s move follows an inspection by the French medicines agency (ANSM) which raised concerns over study data used by GVK Bio to support the marketing authorisation applications of generic medicines. "The review will cover nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences Pvt Ltd, Hyderabad.The review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission, under Article 31 of Directive 2001/83/EC," EMA said in a release. When contacted GVK, a company official said that from May 19- 23, a regulatory inspector from ANSM inspected their clinical facility in Hyderabad and the company has submitted necessary clarifications to the French authorities.

"Further, we were invited by the European authorities, GVK BIO met the European authorities in-person last week, presented the data and demonstrated how we have optimised our processes internally. We are in the resolution stage and hope to close the matter to their satisfaction at the earliest. We are expecting the closure (of the matter) by October 26," the official added. (With inputs from agencies)

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