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The EMA/CVMP Guideline on the demonstration of palatability of veterinary medicinal products and its practical implementation

On 1FEB2015, a new guideline came into effect in the EU. Marketing authorisation holders, who wish to claim palatability for their product, will have to provide data supporting such claim. The guideline provides guidance on the design, conduct and evaluation of studies for demonstration of palatability for the treatment of individual animals, both for new oral formulations as well as existing products if reformulated. The guideline also applies for generic products intended for herd/group treatment as this is considered important with regard to efficacy and safety being not covered in the bioequivalence guideline. It is required to demonstrate palatability in VICH-GCP compliant in-vivo studies in each species and potentially subgroups, assuring that it is representative for the target population. Assessment of palatability should be without food and reflecting the administration as specified in the SPC. The study design should demonstrate the voluntary full consumption within maximum offering time (e.g. 2 minutes), analysed as the acceptance rate. Non-acceptance is defined by one of the following criteria: delayed uptake, partial uptake, regurgitation or spitting out and refusal. Secondary endpoints may be the average voluntary acceptance rate for each time point, scoring of ease of administration and rates of the different failures as defined in the protocol. Any study outcome must be relevant for the target population, which may be affected by different factors (e.g. conditioning, breed, disease, feeding). Generics intended for oral treatment of herds or groups and not being qualitatively and quantitatively comparable to the reference product need specific attention. References: 1. EMA/CVMP/EWP/206024/2011: Guideline on the demonstration of palatability of veterinary medicinal products 2. EMA/CVMP/016/00-Rev.2: Conduct of bioequivalence studies for veterinary medicinal products

DATE » 19.05.2015

AUTHORS » Hellmann, Klaus; Claudia Schneider

PUBLISHED » Proceeding of the 19th Biennial Symposium of the American Academy of Veterinary Pharmacology and Therapeutics, Fort Collins, Co. USA
May 17 - 20, 2015, Poster 4