ABSTRACT
INTRODUCTION Since the start of the efforts in the framework of the International Conference onHarmonization (ICH) of Requirements for Registration of Pharmaceuticals forHuman use in 1989, a lot has been accomplished. As one of the important resultswe have the CommonTechnical Document (CTD) laying out the (identical) structure of the marketing application dossier for the three regions: European Communities, the United States, and Japan. Canada and Australia, who have been observers to ICH, also accept the CTD format, as do many other countries.
