This Guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for 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).
The revisions reflect scientific advice given on the development of antibacterial agents, decisions taken during regulatory procedures and alignments on clinical trial requirements that have resulted from discussions between regulators in the EU, United States and Japan, including revised recommendations for primary endpoints, primary analysis populations and non-inferiority margins in trials to support certain infection site-specific indications for use.
Other updates include clarifications on recommended clinical programmes for antibacterial agents expected to address an unmet need and for combinations of beta-lactam agents with beta-lactamase inhibitors. Guidance has been added on clinical trials to support treatment of uncomplicated urinary tract infections and uncomplicated gonorrhoea. Situations in which single pivotal trials may be accepted to support infection-site-specific indications are described. The guidance on the presentation of the microbiological data and the clinical efficacy data in the Summary of Product Characteristics (SmPC) has been revised.
Some of the information in the previous guidelines has been removed because separate and more detailed guidance has since been issued (see the Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products [EMA/CHMP/594085/2015] and 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]). Furthermore, guidance on paediatric development programmes has been removed due to parallel development of 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/CHMP/187859/2017).
To continue reading this article please go to EMA .