International Risk Assessment

Abstract

The internationalization of drug development and marketing as well as the rapid expansion of international cooperation between drug regulatory authorities, including moves towards supranational decision making, i.e., the European Economic Community (EEC), provide a scenario for the 1990s characterized by many more simultaneous introductions of new major drugs on the world market. This will result in massive exposure of patients of different ethnic origins, age, disease patterns, concomitant therapy, etc., to the new drugs without prior postmarketing surveillance (PMS) in other countries. By and large this evolution is a rational one with regard to development costs, need for rapid access to new medicines, and drug regulatory rigor. At the same time, however, it presents the question of how these drugs with a considerable scope of potential problems should be most effectively followed up in order to minimize health hazards. The responsibility for designing, executing, and monitoring necessary surveillance procedures must be shared by the pharmaceutical industry, the drug regulatory agencies, and the medical community.