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 |