The evolution of safety assessments for veterinary medicinal products in the European Union.
The contents of the safety section of dossiers supporting marketing authorisation applications for veterinary medicinal products have improved markedly over the last 15-20y. This is particularly true for products intended for use in food producing animals and well exemplified in the European Union. The concept of the acceptable daily intake has been refined and in addition to toxicological safety, pharmacological and microbiological considerations are also now taken into account. All of these factors are built into the approach for the elaboration of maximum residue limits for residues of veterinary drugs in food of animal origin, and the subsequent determination of their withdrawal periods in each species. These developments have been matched by improvements in residues surveillance. More emphasis is now given to the safety of those using veterinary medicinal products, and to possible environmental effects. Consumers, users and the environment are therefore better protected from any potential harmful effects. Both industry and regulatory authorities have invested significant efforts into communicating these developments to the public. However, it is still worthwhile questioning whether more can be done to bring these achievements to a wider public audience, and thus to increase confidence in the safety of veterinary medicines by both consumers and user alike.
Woodward
Kevin
K
Schering-Plough Animal Health, Breakspear Road South, Harefield, Uxbridge, Middlesex UB9-6LS, United Kingdom.
D000818:Animals; D003257:Consumer Product Safety / Q000592:standards*; D004350:Drug Residues; D005062:European Union; D006801:Humans; D008460:Meat / Q000592:standards*; D019155:Veterinary Drugs / Q000592:standards* / Q000633:toxicity*
D019155:Veterinary Drugs