Recently, the dangerous lack of adverse drug reaction data in Europe reflecting the “real world”—the postmarketing stages—has led to directives and Good Clinical Practice guidelines by the European Economic Community. This is a step in the right direction; however, much more needs to be accomplished. It is clear that Europe needs a multipurpose data base and major academic and training facilities that can be used for managing adverse reaction information. The issues involved for pharmaceutical companies in managing drug reaction data are also covered.
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