School of Business Administration, Shenyang Pharmaceutical University, Shenyang, 110016, People's Republic of China.
Drug Regulatory Research Base of NMPA - Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang, 110016, People's Republic of China.
Ther Innov Regul Sci. 2024 Jan;58(1):34-41. doi: 10.1007/s43441-023-00588-0. Epub 2023 Nov 23.
Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical practice, which can be analyzed to generate real-world evidence (RWE). The Chinese government has been actively promoting regulatory reform that is in line with the characteristics of TCM, optimizing the clinical evidence system for TCM, and exploring the important role of RWE in supporting the development of new drugs and regulatory decision-making for TCM. This article aims to provide a comprehensive review of the use of RWE in regulatory decisions for TCM. Based on the characteristics of TCM, this study focuses on the application scenarios, challenges, and opportunities of RWE in TCM. And some suggestions are put forward to promote the wider application of RWE in TCM development and supervision.
中医（TCM）是中国特有的宝贵资源，具有悠久的人类使用和临床实践历史，可以进行分析以生成真实世界证据（RWE）。中国政府一直在积极推动符合中医药特点的监管改革，优化中医药临床证据体系，探索 RWE 在支持中药新药开发和监管决策中的重要作用。本文旨在全面回顾 RWE 在中药监管决策中的应用。基于中医药的特点，本研究重点关注 RWE 在中医药中的应用场景、挑战和机遇。并提出了一些建议，以促进 RWE 在中医药发展和监管中的更广泛应用。
