When developing a veterinary product for the global market, differences in product categorisation and applicable regulations can be difficult to navigate. The final article in the “From molecule to market” series provides an overview of the regulation for animal health products in the European Union and the United States.
This is the third article in the "From molecule to market" series, where the challenges to successfully run a clinical program for the registration of new veterinary medicinal products shall be described. While traditionally all safety and efficacy studies conducted in the target animal species are considered clinical studies, the European Union (EU), lately, has introduced a more restricted definition of clinical studies being the pivotal field efficacy and safety studies only. In this article, we will focus on the field studies, while providing some considerations for preclinical studies as defined now in the EU.
The present field study has evaluated the safety and three month preventive efficacy of a novel spot-on endectocide containing emodepside 2.04 w/v, praziquantel 8.14 w/v and tigolaner 9.79 w/v (Felpreva®, Vetoquinol) when administered at the intended commercial dose of 0.15 mL/kg body weight to privately owned cats infested by fleas (Ctenocephalides felis) and/or ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus spp.).
Multicenter randomized, and blinded European field study evaluating the efficacy and safety of Felpreva®, a novel spot-on formulation containing tigolaner, emodepside, and praziquantel in treating cats with mixed infection with nematodes, cestodes and/or lungworms.
Twenty-one years after Directive 2001/82/EC regulating veterinary medicinal products (VMPs) came into force, a new veterinary regulation will apply from 28 January 2022. Future applicants will have to follow the requirements of Regulation (EU) 2019/6. This regulation defines different products, non-biologicals (equivalent to formerly defined pharmaceuticals), and biological products. Biological VMPs belong either to the new class, non-immunological VMPs or immunologicals, including those known as vaccines. This new regulation also defines novel therapies covering innovative medicinal therapeutic approaches. Antiparasitic products will always be VMPs, and additional requirements for environmental safety and potential risks for the development of resistance are enforced.
As clinical field studies serve as pivotal data to obtain a marketing authorisation for animal health products, quality requirements are abundant. Regular audits enhance the quality of studies and thus facilitate the review process by the regulatory authorities, by providing confidence in the data integrity of studies. In the past year, the ability to perform physical on-site audits was challenged due to travel restrictions and social distancing rules associated with the COVID-19 pandemic. Subsequently, remote site audits became a well-accepted and convenient alternative to conventional physical on-site audits.
We thank Zoetis for their acknowledgement in this publication: A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis.
