Core Viewpoint - The establishment of a regulatory science framework tailored to traditional Chinese medicine (TCM) is essential to address the unique characteristics of TCM and improve drug evaluation standards [1][2][3]. Group 1: Challenges in Current Drug Evaluation - The existing drug evaluation system, largely based on Western methodologies, fails to capture the multi-component and multi-target nature of TCM [1]. - A significant concern is the low efficacy of target-based drug discovery, with only 9.4% of small molecule drugs developed based on target theory [2]. - The complexity of TCM's metabolic processes and mechanisms has led to a lack of industry acceptance for existing regulatory tools and standards [3]. Group 2: Regulatory Science Development - The National Medical Products Administration (NMPA) has initiated research into regulatory science for TCM, emphasizing the need for new tools, standards, and methods [2][3]. - Cross-disciplinary collaboration is essential for developing a comprehensive regulatory framework, integrating expertise from various fields such as informatics and engineering [3]. Group 3: Technological Advancements - The adoption of advanced technologies, including AI and organ-on-a-chip models, is recognized as a means to enhance the regulatory process and reduce drug development costs [4][5]. - The application of cutting-edge technologies in TCM research and development is crucial for modernizing and internationalizing the entire drug development process [5].