FDA Acceptance of Foreign Inspections

Abstract

The Food and Drug Administration's (FDA) acceptance of foreign inspections is becoming an increasingly important issue in light of the international efforts to harmonize the regulation of pharmaceuticals. In addition, the developments in the European Community and elsewhere have created an environment where reliance on inspection reports generated by the host country has increasing appeal. This paper covers FDA's current view of agreements to exchange good manufacturing practice (GMP) inspection reports with other countries.