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Table 2 Overview of GCP-regulations for clinical trials in veterinary medicine valid for EU-member states and the USA

From: Translating clinical trials from human to veterinary oncology and back

Country Regulation Legal status
EU (individual member states) National laws of EU member states (e.g. the Austrian “Tierversuchsgesetz 2012” [23]) National laws (e.g. Austria:, clinical trials perceived as animal experiments)
EU Directive 2010/63/EU on protection of animals used for scientific purposes [24] Not applicable for clinical trials in animals
EU and USA VICH Consensus Guidelines for Good Clinical Practice [25] Recommendation
USA Good laboratory practice for nonclinical laboratory studies (CFR Title 21, Part 58 [26]) Not applicable for clinical trials in animals
USA Animal Welfare Act and Animal Welfare Regulations [27] Applicable for animals used for scientific purposes