›› KLIFOVET › EXPERTISE › PUBLICATIONS

The draft of the revised EMA/CVMP "Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the prevention of tick...

... and flea infestations in dogs and cats". EMA/ CVMP has published the 3rd revision of this guideline. Ectoparasitic products represent the commericially most interesting sub-market in animal health. Multiple new products have been developed in the previous years. For generics, one dose conformation study is required per parasite in the future, unless a true generic approach using bioequivalence or least sensitive species can be applied. In-vivo efficacy calculations between groups should test for statistical significance of 5%. For new products' flea and tick claims, dose determination and two dose confirmation studies are required followed by a field study. Abbott's formula providing for 95% flea or 90% tick count reduction based on the arithmetic mean are mandatory for laboratory studies. Immediate efficacy should be proven within 0 to 24 hours post treatment. Short term and long term persistant efficacy claims are defined. Specific requirements for the speed of kill define a threshold 95% flea count reduction within 24 hours applying a minimum dose. Further details are given for IGRs and water stability. Updated guidance on tick efficacy assessment is driven by parental applied products being registered recently. The assessment of the acaricidal effect has been adapted, removin the engorgement status as a creterion of efficacy. The acaricidal effect is now based on the attachment status (free or attached) and the acaricidal effect (yes or no) only. The demonstration of immediate acaricidal effect is the precondition for the claim "treatment of existing tick infestations. While locally acting products may generate both a repellent and a killing persistent activity, systemically acting products can by the nature of its effect have only klilling activity and a transmission of infectious diseases can not be excluded. This proposal for the revision of the guideline may be commented until end of September 2015, The final version of the guideline is expected early 2016.

DATE » 11.07.2015

AUTHORS » Klaus Hellmann; Dejan Cvejic; Claudia Schneider

PUBLISHED » 60th Annual Meeting of th American Association of Veterinary Parasitologists, July 11-14, 2015, Boston, Massachusetts: Poster 164