An Evaluation of Medicines Regulation

Abstract

The regulation of medicines in the United Kingdom has changed radically over the course of the last thirty years. Originally regulation was generally concerned with maintaining the quality and purity of drugs, investigations concerning the efficiency or safety of medicinal products are a more recent phenomenon. Regulation of medicine is now overseen by the European Union and licensing applications that are approved under this new scheme are likely to have wide implications not only for the Member States of the EU, but for non-Member States who have signed to the European Free Trade Agreement (EFTA), and possibly for producers of medicines in the United States. The regulatory system that currently applies in the UK, named the “Future System” of medicinal regulation came into being in January 1995. Although in its early days this paper examines the regulation of medicine in both the United Kingdom, and Europe; giving a broad outline of the new regulatory structure; and comparing and contrasting the way that Europe and the United States of America regulates and approves medicines. The final section considers the performance of the new regulatory structure by an examination of the first general report of the European Agency for the Evaluation of Medicinal Products, along with the results of a questionnaire survey conducted primarily with pharmaceutical manufacturers in the UK which aimed to elicit their views on how the new regulatory system is working, and whether it is operating to the standards which are expected of it.