中藥監(jiān)管科學(xué)是保障中藥質(zhì)量、安全性和有效性的關(guān)鍵支撐，是近年來國家高度關(guān)注的新興學(xué)科。隨著中藥產(chǎn)業(yè)快速發(fā)展和國際化進程推進，傳統(tǒng)監(jiān)管模式已不能滿足實際需要。本文從中藥監(jiān)管工具現(xiàn)代化、法規(guī)體系構(gòu)建、方法創(chuàng)新與智能平臺建設(shè)等方面，系統(tǒng)梳理我國中藥監(jiān)管科學(xué)的發(fā)展現(xiàn)狀，重點介紹雙向預(yù)警系統(tǒng)、“三結(jié)合”審評體系、人工智能在質(zhì)量控制與不良反應(yīng)監(jiān)測中的應(yīng)用等典型進展，深入分析監(jiān)管中存在的瓶頸問題，并提出推動智能化、全生命周期監(jiān)管、國際標(biāo)準(zhǔn)融合的對策建議，旨在為我國中藥監(jiān)管科學(xué)體系優(yōu)化提供理論支撐與實踐參考。

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.

R951

早期冠心病無創(chuàng)心音智能識別云平臺建立和臨床應(yīng)用天津市教委科研計劃項目重點項目（ 2022YGZD01） ； 天津市衛(wèi)健委中醫(yī)中西醫(yī)結(jié)合科研課題（2021161）