EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate methods to identify and describe the pharmacology of the active substance in relation to the target bacteria are presented and important aspects to consider for justifying the use of a certain active substance for a particular indication are outlined.