ABSTRACT
MODULE 1: ADMINISTRATIVE INFORMATION The ICH Harmonised Tripartite Guideline M4(R3) on Organisation of the Common Technical Document (1) indicates that the Common Technical Document (CTD) Module 1 should contain administrative documents specific to each region, for example, forms, labeling, etc., and that the format be specified by the relevant regulatory authorities. Therefore, Module 1 is the one module in the CTD that is not common among the various regions. This chapter reviews the contents of Module 1 in each of the three ICH regions in the following order-–Europe, Japan, and the United States. The format and contents of Module 1 for other countries is available from Web sites of the national competent authorities such as that for the Therapeutic Goods Administration (TGA) in Australia (2).
