Abstract: The traditional Chinese medicine preparations in medical institutions embody immense potential for the innovation and development of new Chinese medicinal products. However, due to the unique diagnostic and therapeutic concepts and theories of traditional Chinese medicine (TCM), the current research and development pathways for new Chinese medicinal products, particularly the evaluation pathway for their clinical efficacy, cannot be completely replicated from conventional chemical drugs. To accelerate the development of the industry of innovative traditional Chinese medicines and facilitate the implementation of traditional Chinese medicine preparations in China, it reviews the recent research on drug clinical efficacy evaluation methods through literature review and case study, integrates the advantages of existing drug clinical efficacy evaluation methods, and designs a clinical efficacy evaluation framework for traditional Chinese medicine preparations in medical institutions based on pragmatic clinical trials (PCT), encompassing such three dimensions as safety, efficacy, and suitability, along with a dimension specific to traditional Chinese medicine, as well as over 20 subdivided operational indicators.