《中藥注冊(cè)管理專門規(guī)定》頒布后，治療癥狀類中藥新藥研發(fā)迎來新機(jī)遇，但同時(shí)也要清醒認(rèn)識(shí)到治療癥狀類中藥新藥臨床試驗(yàn)在指標(biāo)設(shè)計(jì)及數(shù)據(jù)質(zhì)量方面的新挑戰(zhàn)。在以患者為核心新藥研發(fā)大背景下，充分梳理“癥狀”概念內(nèi)涵與外延基礎(chǔ)上，全面了解國(guó)內(nèi)外監(jiān)管機(jī)構(gòu)對(duì)“癥狀”療效指標(biāo)設(shè)計(jì)的最新技術(shù)要求，結(jié)合中藥新藥研發(fā)的實(shí)際情況，最終對(duì)形成適合中藥新藥研發(fā)的癥狀類指標(biāo)設(shè)計(jì)的技術(shù)要求提供建議，以期為同類中藥新藥研發(fā)提供借鑒。

After announcement of the Special Provisions on the Administration of Traditional Chinese Medicine Registration, opportunities have enhanced for the development of new Chinese materia medica which improving symptoms, but at the same time, new challenges of clinical trial in efficacy outcome indicator design and quality control have occured as well. In the context of patient-focused drug development, thoroughly understand the connotation and extension of "symptoms", comprehensively understand the latest technical requirements of domestic and foreign regulatory agencies for the design of efficacy indicators, effectively integrate the actual development situation of new Chinese materia medica, finally provide suggestions about technical requirements and expect to provide reference for the development of similar new Chinese matria medica.

R286，R969.4

上海市中醫(yī)藥“三年行動(dòng)計(jì)劃”項(xiàng)目［ZY（2021-2023）-0211］；上海市“科技創(chuàng)新行動(dòng)計(jì)劃”生物醫(yī)藥科技支撐專項(xiàng)（20S21902100）；上海市教委協(xié)同創(chuàng)新中心：中西醫(yī)結(jié)合-中成藥臨床評(píng)價(jià)平臺(tái)項(xiàng)目（A1-U21-205-0103）；上海市慢性筋骨病臨床醫(yī)學(xué)研究中心項(xiàng)目（20MC1920600）；上海市科委2022年度第三批應(yīng)急科技攻關(guān)項(xiàng)目（22YJ1900505）；上海市申康中心示范性研究型病房建設(shè)項(xiàng)目（SHDC2022CRW010）；上海市申康中心醫(yī)企融合創(chuàng)新協(xié)同專項(xiàng)（SHDC2022CRT018）