Theoretical innovation and practical research of the pharmacovigilance system for traditional Chinese medicine

With the increasingly extensive application of traditional Chinese medicine (TCM), its safety issues have drawn extensive attention. Establishing a pharmacovigilance system that combines the characteristics of TCM with modern scientific connotations is an urgent task. After over two decades of systematic research, our team at Beijing University of Chinese Medicine has established a distinctive TCM pharmacovigilance system, integrating four key dimensions, including theoretical innovation, practical strategies, technological platforms, and translational application. The team has systematically constructed the theoretical framework of TCM pharmacovigilance, clearly defining its cognitive foundation, theoretical characteristics, core academic content, as well as its connotation and extension. And they put forward a practical strategy of "cognition, application, prevention, and rescue of drug toxicity" for TCM pharmacovigilance, and constructed a "four-dimensional integrated" pharmacovigilance technology platform for TCM by integrating modern technologies such as big data and artificial intelligence. Ultimately, through the multi-dimensional collaborative transformation of "government-industry-healthcare-education-research," the theoretical research findings had been effectively translated into practical applications. The establishment of the system builds upon classical traditions while aligning with international standards, creating an integrated safety assurance framework that spans all TCM stages-from research and development, through production and distribution, to clinical application. It enables comprehensive risk management across the entire TCM life cycle, fills a critical gap in current research, and provides robust support for the safe and rational use of TCM, as well as for the inheritance and innovative advancement of TCM as a discipline.