PDF(Pubmed)
Abstract：
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.
摘要：
中药是我国特有的宝贵资源,具有悠久的人类使用和临床实践的历史,可以对其进行分析以生成真实世界证据(RWE)。中国政府一直积极推进符合中医药特点的监管改革,优化中医临床证据体系，并探讨RWE在支持中药新药开发和监管决策中的重要作用。本文旨在对RWE在中医监管决策中的应用进行全面综述。根据中医的特点,这项研究的重点是应用场景，挑战,以及RWE在中医领域的机遇。并提出了促进RWE在中医药发展和监管中广泛应用的建议。
