The European Medicines Agency (EMA) has released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. Among the key issues, this document outlines new approaches for the development of antibacterial agents against multidrug-resistant pathogens and data-gathering strategies to support the benefit-risk evaluation as part of the marketing-authorisation process.

These themes have also been discussed during a workshop, ‘Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem’, hosted by EMA in November 2013. More information is available on the EMA website.