What is the European Clinical Trials Directive (EU Directive / CT Directive)?
In May 2001, the current EU Directive was published on the conduct of clinical trials in Europe. The EU Directive (2001/20/EC) relates “to the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use”, and is aimed at the regulation of clinical trials within the European Union and was transposed by each EU country into its own law. All interventional clinical trials are covered by the CT Directive and require authorisation by each EU country’s regulatory body – such as the Medicines Control Agency (MCA) in the UK. In effect, every interventional clinical trial involving medicinal products is covered, whoever sponsors it, whether industry, government, research council, charity or university. The key points of the CT Directive are: – Protection of clinical trial subjects – Procedures for Ethics Committees – Exchange of information between the regulatory bodies and the European Medicines Agency (EMA) – Standards for Good Clinica
