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 |