EMA Clarifies Quality And Equivalence Testing Expectations For Cutaneous Products

New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.

The EMA guidance deals with locally applied and locally acting medicines for cutaneous use • Source: Shutterstock

EU guidance is now available on how to meet quality requirements for cutaneous products that are not covered by other guidelines or pharmacopoeial standards, and how to conduct equivalence testing of such products in lieu of therapeutic equivalence studies with clinical endpoints.

The guidance, published by the European Medicines Agency this month, follows a public consultation on the draft version of...