Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMA/CHMP/EWP/14377/2008 Rev. 1
Published03/08/2017
Effective from01/02/2018
KeywordsMycobacterium tuberculosis, pulmonary and extrapulmonary tuberculosis, combination regimens, multidrug resistant M. tuberculosis, early bactericidal activity (EBA), sputum culture conversion (SCC)
DescriptionThis document is an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. It covers the evaluation of agents for the treatment of disease due to Mycobacterium tuberculosis.


Document history

Revision 1

Current version

PDF iconAdopted guideline

PDF iconDraft guideline

PDF iconConcept paper

Published: 03/08/2017

In operation: 01/02/2018-present

Published: 01/08/2016

Published: 28/11/2014

First version

PDF iconAdopted guideline


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/08/2010-01/02/2018


Published: 24/04/2008


Published: 26/04/2007


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