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The Integrated Clinical and Statistical Report for Registration in Taiwan*

Registration clinical trials conducted to obtain and present efficacy and safety data on a new drug in the Taiwanese population have been required for marketing approval in Taiwan since August 1, 1993. In order to facilitate the review process and to be in compliance with the International Conference on Harmonization (ICH) and the United States Food and Drug Administration guidelines, a proposed standard for the minimal requirements on the format and contents of an integrated clinical and statistical report is provided. The proposed format and contents for Taiwan follow the format and contents of the ICH “Guideline on Structure and Contents of Clinical Reports” as much as possible. As a result, sponsors do not have to use a new format and contents and the duration of the review process can be reduced in Taiwan. Issues in registration trials conducted in Taiwan are also presented and discussed.