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EMA Clarifies Quality And Equivalence Testing Expectations For Cutaneous Products

 
• By Neena Brizmohun

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

Key Takeaways

  • The European Medicines Agency has publish guidance on the quality and equivalence testing of locally applied, locally acting cutaneous products.

  • The guidance will come into effect on 2 April 2025

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