Abstract:Quality by design (QbD) is the total of design science and manufacture science. The design thinking and methods run through the entire process of drug research, development, production and circulation. Moreover, design is decisive for the quality of medicinal products. Traditional Chinese Medicine (TCM) design is guided by Chinese medicine theory and combines the effective use of multidisciplinary scientific principles to ensure the quality of TCM to meet the needs of clinical disease prevention and treatment process. This article summarized the TCM product design including formula design, drug design and dosage form design, and the TCM pharmaceutical process design under the theory of “unification of medicines and excipients” including the TCM formula design, TCM manufacturing route design and pharmaceutical engineering design. With the development of data science and artificial intelligence, TCM intelligent design methods based on big data, knowledge and rules, such as expert system (ES), manufacture classification system (MCS) and intelligent traditional Chinese medicine system (iTCM), which improved the TCM design efficiency and enriched the content of Chinese medicine quality by design.