Paul J. A. Demoen

Labeling of Clinical Trial Samples: An Overview of Some Regulatory Requirements

This paper gives an overview of some regulatory requirements for the labeling of clinical trial samples. The regulatory requirements of the following countries were investigated: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, The Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom, and the United States. It can be concluded that, due to the different requirements in regulation, the manufacture of standard international labels is not feasible. To reduce the diversity in labeling requirements, a common attitude — at least within the European Economic Community (EEC) — towards the nature of the information on a clinical trial label is needed