The Future GMP Inspection System (Inside and outside the European Community): What Does Subsidiarity Really Mean?

Abstract

This paper covers the “new system” for marketing authorization in the European Community, particularly with regard to the manufacture and import of medicinal products, effective from 1995 onwards. The role of national inspection services will be modified under this system, in order to move from a country-by-country system to a community-wide system. Harmonization of inspection practices, preapproval inspections, laboratory controls, and relations with non-European Community countries have all been rethought. Manufacturing of investigational medicinal products is covered by good manufacturing practice.