Comments invited on guideline for the demonstration of efficacy for veterinary medicines containing antimicrobials

News 29/05/2013

The European Medicines Agency has revised and published the PDF icon guideline for the demonstration of efficacy for veterinary medicines containing antimicrobial substances for public consultation.

The initial guideline came into effect in June 2003, and since then much attention and work have been focusing on the responsible use of antimicrobials in the European Union , especially to reduce the risk of development of antimicrobial resistance. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) published the PDF icon CVMP strategy on antimicrobials 2011-2015 two years ago. This strategy was also considered when revising the guideline.

The revised guideline provides more detailed recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for antimicrobial veterinary products.

Appropriate methods to identify and describe the pharmacology of the active substance in relation to the target bacteria in preclinical studies are presented. The guideline also outlines important aspects to consider in justifying the use of a certain active substance for a particular indication.

The guideline gives more detailed advice for clinical studies regarding study design, selection of comparators and efficacy endpoints, in order to gain conclusive results. In particular, it gives more advice on the design of clinical studies in support of the newly introduced claim for metaphylaxis and its differentiation from prevention claims. In case of an outbreak of a disease in a herd, it may be relevant, from an epidemiological point of view, to treat animals that are still clinically healthy but likely to be infected due to close contact with diseased animals. The guideline clarifies the conditions within which such preventative treatment could be accepted.

The revised guideline also provides more guidance on superiority trials. It makes reference to official guidance (such as CVMP recommendations) on preferred choices of antimicrobials to be used and those to be reserved for certain conditions, and indicates that these recommendations should be considered when taking decisions on which populations to include in the studies.

The public consultation for this guideline ends on 30 November 2013. Comments should be sent to vet-guidelines@ema.europa.eu using the form provided.

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