EMA prepares for changes to non-inferiority, equivalence study guidance

The Eu­ro­pean Med­i­cines Agency is gear­ing up to make changes to its decades-old guide­lines for how drug spon­sors should use non-in­fe­ri­or­i­ty and equiv­a­lence stud­ies to com­pare new prod­ucts to ex­ist­ing ones.

In a con­cept pa­per pub­lished Fri­day for the up­com­ing guide­line, the EMA laid out its plans to merge its ex­ist­ing doc­u­ments on non-in­fe­ri­or­i­ty that were pub­lished near­ly two decades ago. Com­ments on the doc­u­ment are due by the end of May.

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