The mechanics of assembling an international drug dossier.

Abstract

An international registration dossier is a comprehensive scientific document used to obtain worldwide licensing approval of a drug by diverse health authorities. Its creation, processing, compilation, and dispatch to the field by a regulatory affairs department of a major, US-based, multinational pharmaceutical company is dependent upon many interrelated activities beginning years prior to its physical assembly. The following activities are briefly discussed to show the magnitude of the task and the type of activities encountered: planning and scheduling; creating, organizing, and formatting; typing; copying and collating; working with extramural suppliers and services; and finally, shipping the document to the field. Suggestions for making the process more efficient are offered.