European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other regulators globally.
This guideline merges, revises, and adds to the guidance previously included in the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections (CPMP/EWP/558/95 Rev 2) and the Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013).
In the face of increasing problems posed by bacterial resistance, there is a pressing need for new antibacterial agents suitable for treating infections in patients with few remaining therapeutic options.
This guideline will facilitate clinical development programs for new antibacterial agents and support modifications to the uses and/or regimens for licensed agents there is a need to ensure that each clinical trial conducted can be designed to meet the requirements of multiple regulatory agencies.
The guideline is relevant to antibacterial agents with a direct action on bacteria resulting in inhibition of replication leading to bacterial cell death.
The guidance includes antibacterial agents administered systemically (including oral administration to treat pathogens that are confined to the gastrointestinal 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.
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