International marketing applications according to the ICH CTD format: Comparison of structure and document requirements

Abstract

With the development of the Common Technical Document (CTD) by the International Conference on Harmonisation (ICH), United States, European Union and Japan now have a common format for the organization of documents in regulatory applications. This paper presents a top-level assessment of how the required technical contents of the Biologic License Application (BLA), the Marketing Authorization Application (MAA) and Japan's New Drug Application should be structured according to the ICH CTD format. The article may be of assistance for Quality Assurance auditor when auditing MAAs. Copyright © 2006 John Wiley & Sons, Ltd.