The official release of the “Drug Registration Management Measures” in January 2020 marked a new milestone in the classification management of traditional Chinese medicine (TCM) registration, ushering in a new era for the registration and application of innovative TCM drugs. This article provides a detailed analysis of the approval status of innovative TCM drugs, improved new drugs, and ancient classic prescription compound preparations from 2020 to 2024, revealing the significant achievements made in the inheritance and innovation of TCM in China. The study found that the number of New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) have increased annually, with a particularly notable surge in the submission of applications for classic prescription compound preparations. The approval rates for innovative TCM drugs and improved new drugs have significantly increased, along with the streamlining of review and approval process, leading to shorter development cycles and reduced costs. Key findings include: (1) Enterprises demonstrate strong enthusiasm for the research and development of innovative and improved TCM drugs, actively engaging in various types of drug R&D and submissions; (2) Classic prescription compound preparations have become a focal point for enterprises due to their shorter development cycles and lower costs; (3) Improvement to the “three-combined” evidence system has accelerated the R&D process by incorporating real-world data. Through this study, we aim to provide valuable insights for TCM R&D enterprises and policymakers, promoting the sustained prosperity and development of the TCM sector.
