Drug Safety: Legal Requirements in Europe and in the United States — A European Industry View

Abstract

Legal requirements regarding drug safety remain a puzzling matter for a drug company even inside the European Union. In carrying out clinical trials, European investigators have achieved considerable progress in complying with the American rules, although the European Union has provided some indications in good clinical practices guidelines. Undoubtedly, the International Conference on Harmonization two (ICH₂) process speeds up harmonization not only between the United States, Europe, and Japan but also between the European countries. As far as marketed drugs are concerned, the management of a pharmacovigilance network will be a major activity of the future European agency; the main rules will be similar to those of the Food and Drug Administration (FDA). Harmonization of drug safety requirements should be encouraged not only in the reporting of adverse drug reactions but also in the quality of recorded data. This would then require a consensus on good pharmacovigilance practices, definition of medical terms, and a causality assessment method.