Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract

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Download document Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract
Reference number EMA/CHMP/558326/2013
Status draft: consultation closed
First published 2013-10-01
Last updated 2013-10-01

Summary

The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents provides general recommendations on the clinical requirements for respective formulations with known active substances. This concept paper discusses the need to expand the guidance on locally applied and locally acting gastrointestinal products.