2008年新藥創(chuàng)制重大專項(xiàng)啟動(dòng)實(shí)施以來(lái)的10多年間，緊密?chē)@構(gòu)建國(guó)家藥物創(chuàng)新技術(shù)體系目標(biāo)，為我國(guó)新藥研發(fā)和公眾用藥安全提供了重要的保障，獲得重大進(jìn)展。藥品監(jiān)管科學(xué)是近十幾年發(fā)展形成的前沿學(xué)科，受到世界科學(xué)界和管理界的重視。本文秉著中藥監(jiān)管科學(xué)發(fā)展與現(xiàn)實(shí)存在問(wèn)題，需要理論創(chuàng)新、藥物創(chuàng)新、技術(shù)創(chuàng)新、方法創(chuàng)新和應(yīng)用創(chuàng)新。中藥監(jiān)管科學(xué)研究計(jì)劃是國(guó)家推進(jìn)的9個(gè)監(jiān)管科學(xué)行動(dòng)計(jì)劃之一。啟動(dòng)以中藥臨床為導(dǎo)向的中藥安全性評(píng)價(jià)研究，構(gòu)建中藥安全性和質(zhì)量控制體系。作者認(rèn)為通過(guò)監(jiān)管科學(xué)研究，制定科學(xué)規(guī)范的中藥質(zhì)量標(biāo)準(zhǔn)和評(píng)價(jià)指導(dǎo)原則和技術(shù)指南，推進(jìn)中藥材、中藥飲片和中成藥，特別是經(jīng)典名方制劑品種示范研究，有利于中藥產(chǎn)業(yè)健康科學(xué)發(fā)展。在本文中還結(jié)合當(dāng)前的中藥監(jiān)管科學(xué)問(wèn)題，加強(qiáng)藥材和飲片的基礎(chǔ)研究、中藥注射劑質(zhì)量療效的再評(píng)價(jià)研究、經(jīng)典名方的開(kāi)發(fā)和簡(jiǎn)化申請(qǐng)的監(jiān)管科學(xué)研究，提出監(jiān)管科學(xué)研究頂層設(shè)計(jì)建議，制定技術(shù)原則與技術(shù)指南，有利于藥典品種和市場(chǎng)產(chǎn)品的質(zhì)量和臨床有效性再評(píng)價(jià)。

In the more than 10 years since the launch of the major new drug innovation project in 2008, the goal of building a national drug innovation technology system has been closely focused, providing important guarantee for the development of new drugs and public drug safety in China and achieving significant progress. Drug regulatory science is a frontier discipline which has been developed in recent ten years. This paper holds that the scientific development and practical problems of Traditional Chinese medicine (TCM) supervision need innovation in theory, medicine, technology, method and application. The TCM regulatory science research program is one of the nine regulatory science plans promoted by the National Medicinal Product Administration. This project starts the safety evaluation research of TCM products based on clinical practice, and constructs the safety and quality control system. The authors believe that it is beneficial to the healthy and scientific development of the TCM industry to establish scientific and standardized quality standards and evaluation guidelines and technical guidelines for TCM, and to promote the demonstration research on TCM, TCM decoction pieces and proprietary Chinese medicines, especially the classic prescription preparations. Authors also combined with the current scientific issues, strengthen the basic research, medicinal material, decoction and injection quality to evaluate the efficacy of research, to develop simplified application science research of classical formulation, and to put forward the top-level design proposal of regulatory science research, formulate technical principles and technical guidelines. These are helpful for the re-evaluation of the quality and clinical effectiveness of pharmacopoeia varieties and market products.