The European Medicines Agency ("EMA") has recommended the suspension of approximately 700 medicinal products distributed in Europe due to irregularities in their approval process. The recommendation follows an EMA review of findings of the French medicines agency ("ANSM") that GVK Biosciences, the company that carried out the clinical studies upon which the European Union ("EU") authorizations are based, did not comply with good clinical practices ("GCP") at their Hyderabad site in India. In particular, EMA found electrocardiogram data had been manipulated during some generic medicines' studies, which has cast doubt on the reliability of the bioequivalency data used to support the medicines' licenses. The EMA recommendation will be sent to the European Commission, which will consider whether to issue a legally binding decision in the coming days. This decision would apply to all Member States irrespective of whether the country has taken interim measures to suspend the medicine.

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