Europe to suspend about 100 generic drugs after uncovering data 'irregularities' at Indian CRO
The European Medicines Agency is recommending the suspension of about 100 drugs after finding data integrity issues at an India-based CRO that ran tests for the generic drugs.
The CRO in question, Synchron Research Services, isn’t the first to come under the microscope for data failings. The FDA and EMA have raised similar questions in the past regarding data findings from several India-based CROs, including Semler Research and GVK Biosciences. In the case of Semler, as in the case of Synchron, regulators are requiring the drug sponsors to repeat their bioequivalence/bioavailability studies at an acceptable alternate study site.
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