[Expert consensus on organization and implementation of clinical trials for new TCM drugs under review and evaluation evidence system with "three combinations"].

With the in-depth implementation of Opinions of the Central Committee of the Communist Party of China and the State Council on promoting the inheritance, innovation, and development of TCM and Special provisions for the registration administration of TCM, the evidence system of registration, review, and evaluation of TCM, which integrates TCM theory, human use experience, and clinical trials(hereinafter referred to as "three combinations"), has broken through the traditional evaluation model and established a research and development pathway aligns with the characteristics of TCM, and has become a pivotal reform driving the research and development of new TCM drugs. Against this backdrop, experts and representatives from hospitals and enterprises of research and development have developed this consensus through multiple rounds of discussions, aiming to provide a reference for the scientific design, standardized conduct and efficient advancement of clinical trials for new TCM drugs under this system. Centering on human use experience, this consensus elaborated on rational clinical trial planning strategies according to the evidence level of human use experience, the innovative design approaches of trials based on human use experience, the integration and optimized application of domestic and international regulations and technical guidelines, and a full-process communication mechanism and an efficient collaborative framework with clearly defined roles of three parties. It is expected to promote the high-quality development of new TCM drugs in research and development and better meet clinical needs.