Title: One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective
Authors: DAL NEGRO GIANNIESKES CHANTRABELZ SUSANNEBERTEIN CAROLINECHLEBUS MAGDACORVARO MARCOCORVI RAFFAELLADHALLUIN STEPHANEHALDER MARIA ELISABETHHARVEY JAMESHERMANN MARTINAHOFFMANN-DÖRR SIMONEKILIAN KARINLAMBRIGTS DENISLAROCHE CHARLESLOUHIMIES SUSANNAMAHONY CATHERINEMANOU IRENEMCNAMEE PAULINEPRIETO PERAITA MARIA DEL PILARREID KIRSTYROGGEN ERWINSCHUTTE KATRINSTIRLING CATRINAUHLRICH SYLVIEWEISSENHORN RENATEWHELAN MAURICE
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 99 p. 33-49
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2018
JRC N°: JRC111298
ISSN: 0273-2300 (online)
URI: https://www.sciencedirect.com/science/article/pii/S0273230018302137?via%3Dihub
http://publications.jrc.ec.europa.eu/repository/handle/JRC111298
DOI: 10.1016/j.yrtph.2018.08.002
Type: Articles in periodicals and books
Abstract: EU regulations call for the use of alternative methods to animal testing. During the last decade, an increasing number of alternative approaches have been formally adopted. In parallel, new 3Rs-relevant technologies and mechanistic approaches have increasingly contributed to hazard identification and risk assessment evolution. In this changing landscape, an EPAA meeting reviewed the challenges that different industry sectors face in the implementation of alternative methods following a science-driven approach. Although clear progress was acknowledged in animal testing reduction and refinement thanks to an integration of scientifically robust approaches, the following challenges were identified: i) further characterization of toxicity pathways; ii) development of assays covering current scientific gaps, iii) better characterization of links between in vitro readouts and outcome in the target species; iv) better definition of alternative method applicability domains, and v) appropriate implementation of the available approaches. For areas having regulatory adopted alternative methods (e.g., vaccine batch testing), harmonised acceptance across geographical regions was considered critical for broader application. Overall, the main constraints to the application of non-animal alternatives are the still existing gaps in scientific knowledge and technological limitations. The science-driven identification of most appropriate methods is key for furthering a multi-sectorial decrease in animal testing.
JRC Directorate:Health, Consumers and Reference Materials

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