Europe suspends hundreds of generic drugs over serious data concerns

Some 365 generic drugs have had their European Union marketing authorisations suspended after an investigation raised concerns about the reliability of the company that tested them.1The European Medicines Agency’s human medicines committee reviewed 400 generic medicines that have been tested by Synapse Labs, a contract research organisation (CRO) located in Pune, India.2 Of these, just 35 had “sufficient supporting data” to prove bioequivalence and were able to maintain their authorisations.The suspensions followed an inspection of the organisation that found “irregularities in study data and inadequacies in study documentation,” together with problems with computer systems and study data management procedures. “This raised serious concerns about the validity and reliability of data from bioequivalence studies conducted at the CRO,” the EMA said.The regulator added that although there was “no evidence of harm or lack of effectiveness” for the 365 suspended drugs, they have been suspended “until supporting data from more reliable sources…
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