title: How bacteraemia is reviewed by medicines licensing authorities in Europe.
abstract: Bacteraemia has not been recognised as a therapeutic indication in Europe since the publication of the Note for Guidance on Evaluation of Medicinal Products for Treatment of Bacterial Infections in 1997 by the European Medicines Agency (EMEA). This standpoint is in sharp contrast to the labelling decisions taken by the US Food and Drug Administration (FDA). In Europe, a site-specific indication, such as treatment of complicated skin and soft tissue infections is considered to cover cases with bacteraemia, but not vice versa. Only cautionary information is presented in the labelling, e.g. if the number of bacteraemia cases in clinical trials has been low enough to be of concern or if the pharmacokinetic characteristics of the drug may not secure sufficient concentrations in blood. Primary bacteraemia is potentially a situation where the described regulatory paradigm may not apply, but this has yet to be tested. The European approach is likely to be increasingly challenged due to the increasing incidence of bloodstream infections, particularly due to resistant pathogens, and the associated high morbidity and mortality.
authors: NDA Regulatory Science Ltd., Surrey, UK. markku.toivonen@ndareg.com
authors: Markku
authors: M
authors: Toivonen
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy*; D004348:Drug Labeling; D005060:Europe; D006801:Humans; D008004:Licensure
chemical_list: D000900:Anti-Bacterial Agents