International harmonization and enligtenment of the Common Technical Document under the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

Abstract

According to the standard principle of drug registeration,this paper is written to expatiate on the Common Technical Document(CTD) which is inspired and energized by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH).The development of CTD at the ICH6 and the process of implementation of CTD by FDA are summarized.The impact on China registration of pharmaceuticals for human use is(thoroughly) discussed.