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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