Monitoring Safety with Particular Reference to the European Community

Abstract

The European Community (EC) Commission has recently proposed extensive changes in the processes of drug registration and adverse reactions monitoring in Europe. This paper suggests that these EC proposals should be rejected and that effective methods of harmonization should be developed in their place. Finally, the paper emphasizes that, in the interests of the public health, changes in the methods of drug licensing and safety monitoring should be driven by scientific imperatives and not by political or economic considerations.