The Regulation of Clinical Trials in South Africa

Abstract

In South Africa the Medicines Control Council (MCC) is a statutory body responsible for the regulation of all clinical trials undertaken for both non-registered and registered medicines. In this article, we first take a brief look at the legislative background and its development over the last 30 years. We then introduce you to the current regulatory environment, including the structure of the MCC and the clinical trials approvals process. Finally, we look briefly to the future of clinical trials regulation and the progress made by the successful collaboration between the MCC and the clinical trials industry. Copyright © 2004 John Wiley & Sons, Ltd.