ABSTRACT
In the framework of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHumanUse (ICH), the involvedparties [EuropeanUnion (EU), Japan, and the United States (U.S.A.)] have established common reporting standards and template formats. The compilation of these reports forms the basis of the Common Technical Document (CTD) (1-3) (Fig. 1), which has become an internationally agreed format for the preparation of a well-structured presentation for applications to be submitted to regulatory authorities in the European Union, Japan, and the United States. As a result, the applicants have to provide a variety of documents that comply with the ICH guidelines to ensure a rapid and efficient review of their submission. The ICH guidelines provide the framework for themodules that are required as part of the submission of the CTD format marketing authorisation (MA) application.
