Conduction of clinical trials with drugs in Brazil requires prior approval by Committees for Ethics in Research (CEPs) and, in certain cases, by the National Commission for Ethics in Research (CONEP). Approval by the National Health Surveillance Agency (ANVISA), through its Office for New Drugs, Research and Clinical Trials (GEPEC), is currently required only for drugs and medical devices manufactured in other countries and therefore need permission to be imported. This article briefly reviews the history of clinical research regulation in Brazil, then presents an overview of the current regulatory role of ANVISA and its future prospective. Major points discussed are the new forthcoming ANVISA regulations, with emphasis on adverse event notifications and inspections/audits on clinical trials and their impact on clinical research in Brazil, from the standpoint of the industry, university, contract research organizations, physicians and other health professionals. It should be stressed that to decide upon the licensing of new drugs ANVISA must obtain information from clinical trials.