The application of the compound preparation of traditional Chinese medicine (TCM) and chemical drug in clinical has a long history. Drug regulatory requirements of the compound preparation of TCM and chemical drug in various periods were compared and analyzed, and the history and status of the way of scientific supervision of this preparation were summarized. This paper discussed the problems and deficiencies of the compound preparation of TCM and chemical drug, and put forward countermeasures and suggestions about to strengthen the scientific supervision of the compound preparation of TCM and chemical drug.