"Regulatory interdependence in a global economy: The globalization of pharmaceutical regulation in the EU and internationally"

Historically drug regulation has been virtually synonymous with national sovereignty. Over the last decade, this has begun to change: national regulatory agencies are more closely cooperating with one another. The European Union has established a centralized drug approval system; the United States Food and Drug Administration has begun to accept foreign clinical data; and a number of industrial nations have made substantial progress toward standardizing their regulatory procedures and requirements. This paper describes and assesses the implications of recent developments in the international coordination of national drug approval policies. It specifically examines the emergence of a single market for pharmaceutical products in the European Union, the globalization of American drug approval policies, and the accomplishments of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products