This communication is with reference to the circular issued by the European Medicines Agency dated 26th September, 2014. This circular is a follow up action of concerns raised by regulators from ANSM about study data used to support the marketing authorization applications of generic medicines during the period of 19th to 23rd May 2014. At present, the European Medicines Agency (EMA) has initiated a review of the studies on the concerns raised.
GVK BIO is deeply concerned about the concerns raised by ANSM, and have submitted all clarifications along with a detailed Corrective and Preventive Action plan that was accepted by the authorities. We are working with the authorities to resolve the concerns to their satisfaction at the earliest.