RESUMO
This paper introduces the general information of Japanese Kampo preparations, including the catalogue, classification, approval, production and so on, and summarizes their quality characteristics on medicinal materials, formulation, productive process, and quality control. It is suggested that classical representative prescriptions should be selected in combination with clinical application, and the research of classical prescription preparations should follow the guidance of traditional Chinese medicine (TCM) theories and the characteristics of clinical application of TCM, attach important to the research after listed, and strengthen studies on the quality control. Moreover, the reassessment of post-marketed "classical representative famous prescription" preparations should be paid more attention to. The research of new Chinese materia medica (CMM) should strengthen quality control of medicinal materials/pieces source, and new CMM compound preparation research should base on the history of human use. Quality control study of new CMM should base on "quality by design" ideas and concepts, and strengthen process control research and quality standard research.