Last month, the European Medicines Agency ("EMA") confirmed its recommendation to suspend a number of medicines for which authorization in the European Union ("EU") was primarily based on clinical studies conducted by a contract research organization based in India. The original recommendation was adopted by the Committee for Medicinal Products for Human Use ("CHMP") in January 2015, following an inspection that revealed systematic manipulations of electrocardiogram data during the conduct of some studies of generic medicines over a period of five years. During reexamination of the outcome, CHMP concluded there are lingering concerns about the reliability of the clinical studies and that its recommendation to suspend most of the related medicines should therefore be maintained, with the exception of one medicine whose concerns were sufficiently addressed and will no longer be suspended.
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