The Guideline is relevant to antibacterial agents with a direct action on bacteria resulting in inhibition of replication leading to bacterial cell death including:
• Antibacterial agents developed as single agents;
• Antibacterial agents developed for use in combination with one or more other specific antibacterial agent(s), whether co-formulated or co-administered;
• Beta-lactam (BL) agents developed for use with beta-lactamase inhibitors (BLIs), whether coformulated or co-administered.
The guidance includes antibacterial agents administered systemically (including oral administration to treat pathogens that are confined to the gastro-intestinal tract) or formulated for topical administration to the skin. Specific guidance is not provided on the development of antibacterial agents formulated for topical administration to the ears and eyes or for inhalation, although many of the general principles are applicable.
Some principles covered in the Guideline are also applicable to the development of the following, although additional considerations may apply that are not addressed:
• Bacteriophages proposed to treat infections;
• Agents that affect bacterial virulence;
• Agents that inhibit bacterial growth and replication by an indirect effect (e.g. immunomodulators);
• Monoclonal antibodies for treatment or prophylaxis of specific infections. The following are not addressed:
• Clinical pharmacology studies. Available guidance on the pharmacokinetic evaluation of new chemical entities, including population pharmacokinetic analyses, should be followed.
• Pharmacokinetic-pharmacodynamic analyses. This Guideline should be read in conjunction with the Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products (EMA/CHMP/594085/2015).
• Paediatric development programmes. This Guideline should be read in conjunction with the Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/187859/2017), which is under development.
• The clinical development of antibacterial agents intended for the treatment of tuberculosis. This guideline should be read in conjunction with the 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 tuberculosis
[EMA/CHMP/EWP/14377/2008 Rev 1].