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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.