中药监管科学是保障中药质量、安全性和有效性的关键支撑，是近年来国家高度关注的新兴学科。随着中药产业快速发展和国际化进程推进，传统监管模式已不能满足实际需要。本文从中药监管工具现代化、法规体系构建、方法创新与智能平台建设等方面，系统梳理我国中药监管科学的发展现状，重点介绍双向预警系统、“三结合”审评体系、人工智能在质量控制与不良反应监测中的应用等典型进展，深入分析监管中存在的瓶颈问题，并提出推动智能化、全生命周期监管、国际标准融合的对策建议，旨在为我国中药监管科学体系优化提供理论支撑与实践参考。

Regulatory science of traditional Chinese medicine (TCM) is the key support to ensure the quality, safety and efficacy of TCM, and is an emerging discipline that has attracted great attention from the state in recent years. With the rapid development of the Chinese medicine industry and the advancement of internationalisation, the traditional regulatory model can no longer meet the actual needs. In this paper, from the aspects of modernisation of TCM regulatory tools, construction of regulatory system, methodological innovation and intelligent platform construction, we systematically sort out the development status of TCM regulatory science in China, focusing on the typical progresses of two-way early warning system, ‘three-integrated’ review system, and the application of artificial intelligence in quality control and adverse reaction monitoring, and analyse the bottlenecks and problems existing in the regulation. Indepth analysis of the bottlenecks in the supervision and put forward the countermeasures and suggestions to promote the integration of intelligence, full life cycle supervision and international standards, aiming to provide theoretical support and practical reference for the optimisation of China's Chinese medicine regulatory science system.

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早期冠心病无创心音智能识别云平台建立和临床应用天津市教委科研计划项目重点项目（ 2022YGZD01） ； 天津市卫健委中医中西医结合科研课题（2021161）