Dual-driven by regulatory science and policy reconstruction: Traditional Chinese medicine (TCM) new drugs accelerate development-A critical review of highlights in registration and regulation of TCM and natural medicine new drugs in China (2021-2025).

In recent years, China's new round of institution reform has further optimized the drug regulatory system. Relevant departments and institutions involved in traditional Chinese medicine (TCM) regulation have been strengthened. TCM regulatory science, as an emerging interdisciplinary field, has received high regard and experienced rapid development, significantly enhancing TCM regulatory capabilities. Simultaneously, accelerated progress in emerging technologies and production innovation for TCM drug discovery, coupled with the implementation of the National Major Scientific and Technological Special Project for "Significant New Drugs Development" and its translational achievements, have led to a historic turning point in the development of innovative natural TCM drugs over the past five years. Driven by the dual engines of "regulatory science" and "policy restructuring", the development of new TCM drugs has entered a fast lane. Both the quantity and quality of investigational new drug (IND) and new drug application (NDA) registrations and approvals for new natural TCM drugs have shown rapid growth, effectively meeting the public's health demands for TCM products and unmet clinical needs of patients. This study focuses on the development of new TCM drugs during the significant historical phase from 2021 to 2025. It provides a comprehensive overview of new TCM and natural drug applications and regulatory reviews over the past five years, delves into the implementation of the National Drug Regulatory Science Action Plan, and highlights the importance of TCM regulatory science as an emerging interdisciplinary field in accelerating the creation of new TCM drugs. It systematically summarizes the effects of regulatory policies and regulations, the reform of TCM registration classification, specialized TCM registration provisions, and incentive measures such as the National Major Scientific and Technological Special Project for "Significant New Drugs Development". Based on an international perspective, it provides a focused review of recent highlights in TCM new drug development and regulation. This holds significant importance for promoting breakthroughs in TCM new drugs across more disease areas and advancing the international coordination of TCM regulation. The challenge faced in managing the registration of new TCM drugs lies in resolving the conflict between TCM theory and modern drug attributes, while balancing the rapid advancement of traditional medical theory and emerging technologies with the robustness of the drug regulatory framework. In the future, actively advancing research and translation in TCM regulatory science, innovatively establishing benefit-risk assessment systems and standards for new TCM drugs, and accelerating the development of a globally leading regulatory system with Chinese characteristics that aligns with the unique nature of TCM will be particularly crucial for global coordination of TCM regulatory policies, and the modernization and internationalization of TCM.