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The revised draft of the EMA/CVMP "Guideline for the demonstration of efficacy for VMPs contaning antimicrobial substances": Requirements to field studies

Efficacy, next to the Quality and the Safety of an antimocrobial to obtain a marketing authorization for use in Animals, needs to be evaluated and confirmed based on scientific criteria for the species and indication requested. After consultation with the 'interested parties'. EMA and CVMP has released for consultation a revised draft version of the "Guideline for the demonstration of efficacy for veterinary medical products containing antimicrobial substances" (EMEA/CVMP/627/01-FINAL) in March 2015. The requirements for the conduct of field studies are described in detail and will be explained. The authors will give an overview of the latest changes and consequences. The definitions provided for 'treatment, metaphylaxis and prevention' cover most currently foreseeable aspects of the different diseases for the different products with antimicrobial properties that are categorized as falling under the scope of this guidance. It appears that the objective of the revision of this guideline is mainly to support the prudent use of antimicrobials and try to reach a reduction of antimicrobial resistance by putting additional hurdles to obtain a marketing authorization in Europe. The author fears that the availibility of antimicrobial products for animals is not going to improve and it is likely that there will be a reduced number of approved products available to treat relevant, especially minor diseases for food producing animals. This will lead to the use of antimicrobials in species and indications for that they have not been authorized based on a thorough assessment by regulatory authorities in all aspects of quality, safety, and efficacy. The end of the consultation period is in May 2015. The final version of the guideline is expected later this year.

DATE » 19.07.2015

AUTHORS » K. Hellmann, C. Schneider

PUBLISHED » Journal of Veterinary Pharmacology and Therapeutics, Volume 38 supplement, p. 51; July 2015; Special issue: Abstracts of the 13th International Congress of the European Association for Veterinary Pharmacology and Toxicology (EAVPT 2015), 19-22 Juli, Nantes, France.