EMA issues guidance for global development of antimicrobial medicines

The European Medicines Agency (EMA) has published its final revised guideline on the evaluation of human medicines for the treatment of bacterial infections. The guidance forms part of EMA’s efforts to support a global approach to the development of new antimicrobial medicines.

Antimicrobial resistance (AMR) – the ability of microorganisms to resist antimicrobial treatments, especially antibiotics – has a direct impact on the health of people and animals. In the European Union (EU) alone, it is responsible for an estimated 33,000 deaths per year. Its effects are also felt on a financial level worldwide, with AMR estimated to cost the EU €1.5 billion per year in healthcare costs and productivity losses.