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This 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.
Keywords: Mycobacterium tuberculosis, pulmonary and extrapulmonary tuberculosis, combination regimens, multidrug resistant M. tuberculosis, early bactericidal activity (EBA), sputum culture conversion (SCC)
Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address the clinical development of new agents to treat pulmonary disease due to Mycobacterium tubercul...
This revision of the Addendum to the Note for guidance on the evaluation of medicinal products for treatment of bacterial infections to address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis (EMA/CHMP/EWP/14377/2008 Rev. 1) has been produced in response to recent advances and changes in focus in the field.
English (EN) (194.74 KB - PDF)
Draft addendum to the 'guideline on the evaluation of medicinal products indicated for treatment of bacterial infections' to address the clinical development of new agents to treat disease due to Mycobacterium tuberculos...
This addendum replaces ‘Addendum to the note for guidance on evaluation of medicinal products indicated for the treatment of bacterial infections to specifically address the clinical development of
new agents to treat disease due to Mycobacterium tuberculosis (EMA/CHMP/EWP/14377/2008)’.
English (EN) (198.17 KB - PDF)
Concept paper on revision of the 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 tre...
This concept paper proposes a revision of the Committee for Medicinal Products for Human Use's (CHMP’s) 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 (EMA/CHMP/EWP/14377/2008). This addendum came into force 1 August 2010.
English (EN) (85.8 KB - PDF)
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 t...
English (EN) (100.15 KB - PDF)
Draft 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 Mycobacte...
English (EN) (90.25 KB - PDF)
Concept paper on preparation of an addendum to the guideline on development of antibacterial agents to specifically address the clinical development of new agents to treat tuberculosis
English (EN) (92.1 KB - PDF)