Tag Archives: European Clinical Trials Directive

Quality standards and legislation To ensure the overall quality of clinical trials of medicinal products the pharmaceutical industry spearheaded, in January 1997, the use of a set of quality standards known as Good Clinical Practice (GCP).2 In 2001, the European Union (EU) used this approach as the basis for a new draft Directive on Clinical Trials, which would extend the coverage of GCP to include all clinical trials of investigational medicinal products in humans, irrespective of their funding and support.3 For the first time there would be a legal framework for the conduct of clinical trials across Europe and in the UK in accordance with