Evaluation of medicinal products indicated for treatment of bacterial infections

Keywords Non-inferiority studies, superiority studies, susceptibility testing, pharmacokinetic/pharmacodynamic (PK/PD) relationship, bacteraemia, febrile neutropenia, eradication of carriage, drug-resistant organisms; paediatric investigation plan (PIP)
Description This revised draft guideline describes how to carry out studies to demonstrate the benefits and risks of antibiotics, with guidance on study design for specific indications. The draft revision reflects the outcome of cooperation between EMA and international partner regulators to align data requirements as much as possible in Europe, the United States and Japan. In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience gained from previous regulatory decisions. Specific advice has also been added with regards to regulatory requirements in the European Union to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea.

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