Regulatory animal testing for the development of medicines

Abstract

European pharmaceutical legislation requires a valid marketing authorisation for human and veterinary medicinal products before they can be placed on the market to ensure that the benefit of the drug outweighs its risks. In order to obtain such an authorisation, European legislation relating to medicinalproducts for human use (Directive 2001/83/EC) and to veterinary medicinal products (2001/82/EC) requires a dossier containing pharmaceutical and clinical as well as non-clinical safety data, frequently based on results of in vivo studies. Drug safety testing often requires a large number of animals and may cause them considerable pain and distress. In 2010 European laboratory animal legislation was renewed by the adoption of Directive 2010/63/EU, reinforcing that in vivo testing methods have to be refined and alternative testing strategies need to be favoured. Among other institutions OECD and EURL-ECVAM have been contributing to the implementation of the 3Rs in regulatory testing by incorporating refinement techniques into standard in vivo protocols and by establishing and validating alternative approaches, i.e. assays and methods replacing the use of live animals. In the following chapter, the impact of recent legal and scientific measures on drug development, affecting non-clinical safety testing as well as quality testing (i.e. pharmacopoeia) standards in Europe fostering the application of 3R principles, is discussed.