EMA updates guideline on the treatment of bacterial infections

27 Jun, 2022

The European Medicines Agency (EMA) has published the final revised guideline on the evaluation of human medicines for the treatment of bacterial infections.

The revised guideline reflects the outcome of recent discussions between regulators in the EU, United States and Japan on the development of new antimicrobial medicines. Among others, it includes recommendations on the clinical criteria for patient enrolment, the primary endpoint and the primary analysis in infection site-specific trials.

Antimicrobial resistance (AMR) is a global threat that puts children’s health at great risk. WHO estimates that infections caused by multi-drug resistant bacteria cause 700,000 deaths among children of all ages every year.

By releasing the revised guideline, EMA gives state-of-the-art guidance on the development of new antibiotics that could improve the health outcomes of people, including children and young people, across the EU.

Among others, the document provides:

  • clarifications on recommended clinical development programmes for antimicrobials intended to address an unmet need;
  • guidance on clinical trials to support treatment of uncomplicated UTIs and uncomplicated gonorrhoea;
  • updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics.

The guideline is published together with an addendum on clinical development programmes required to support the authorisation of medicines for treatment of bacterial infections in children.

Read the EMA guidance and related content.