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Table 1 Overview of GCP-regulations valid for EU-member states and the USA

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

Country Regulation Legal status
EU EU-GCP “Directive 2001/20/EC” [6] Binding law
EU Guidance documents of the European Commission (i.e. European Commission EUDRACT 2004 [9], European Commission Eudravigilance 2004 [10]) Guidance on the implementation of requirements in Directive 2001/20/EC
EU (individual member states) National laws of EU member states (e.g. the Austrian “Arzneimittelgesetz von 1983, Fassung 2013” [7]) National laws, implementing Directive 2001/20/EC
EU and USA ICH-GCP-guidelines [4] Recommendations, aiming for harmonisation of GCP between USA, Europe and Japan
USA Code of Federal Regulations (CFR Title 21) [8] Binding laws and regulations
USA FDA GCP/Clinical Trial Guidance Documents [11] Guidance on the implementation of GCP-regulations