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 open
First published 01/10/2013
Last updated 01/10/2013
Consultation start date 01/10/2013
Consultation end date 31/12/2013
Email address for submissions pkwpsecretariat@ema.europa.eu

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.