党中(zhong)(zhong)(zhong)央国务院高度(du)重(zhong)视中(zhong)(zhong)(zhong)医药(yao)(yao)事业(ye)，将中(zhong)(zhong)(zhong)医药(yao)(yao)定(ding)位为独特(te)(te)的(de)卫生资(zi)(zi)源、潜(qian)力巨大(da)的(de)经济资(zi)(zi)源、具(ju)有原创优势的(de)科技(ji)资(zi)(zi)源、优秀的(de)文化资(zi)(zi)源和(he)重(zhong)要的(de)生态资(zi)(zi)源。习近(jin)平总书记(ji)对中(zhong)(zhong)(zhong)医药(yao)(yao)工作(zuo)多次作(zuo)出重(zhong)要指示，强调要遵循中(zhong)(zhong)(zhong)医药(yao)(yao)发(fa)展规律(lv)，传承精(jing)华、守正创新，充分发(fa)挥(hui)中(zhong)(zhong)(zhong)医药(yao)(yao)防病治病的(de)独特(te)(te)优势和(he)作(zuo)用。
新(xin)(xin)冠肺炎(yan)疫情(qing)暴发(fa)以来(lai)，中(zhong)医(yi)药在(zai)抗击疫情(qing)中(zhong)彰显特(te)色(se)优势，为(wei)人类健康贡献中(zhong)国智慧(hui)和(he)中(zhong)医(yi)药方案。如何有(you)效、充(chong)分地开发(fa)利用中(zhong)医(yi)药这一(yi)具有(you)独特(te)优势的原(yuan)(yuan)创资源，是(shi)中(zhong)医(yi)药工作(zuo)者必须(xu)深入思考和(he)解决(jue)的关键问题。中(zhong)药新(xin)(xin)药研(yan)究也是(shi)中(zhong)医(yi)药发(fa)展的重(zhong)要领域，充(chong)满挑战，值得广大(da)科研(yan)工作(zuo)者为(wei)之(zhi)努力。中(zhong)药的研(yan)发(fa)要遵循中(zhong)药特(te)点及研(yan)究规律，要坚(jian)持(chi)中(zhong)医(yi)药理(li)论(lun)指导，注(zhu)重(zhong)整(zheng)体观及中(zhong)医(yi)药的原(yuan)(yuan)创思维，注(zhu)重(zhong)临(lin)床实(shi)践(jian)基(ji)础，发(fa)挥中(zhong)医(yi)药防病治病的独特(te)优势和(he)作(zuo)用。
2020年9月28日，国家药(yao)(yao)(yao)监局发布了(le)(le)新(xin)的(de)《中(zhong)药(yao)(yao)(yao)注(zhu)(zhu)册(ce)分类及(ji)申报资料要求(qiu)(qiu)》（简称《注(zhu)(zhu)册(ce)分类》）。《注(zhu)(zhu)册(ce)分类》深刻总(zong)结(jie)了(le)(le)中(zhong)药(yao)(yao)(yao)审(shen)评审(shen)批实(shi)践经(jing)(jing)验(yan)，将中(zhong)药(yao)(yao)(yao)传承(cheng)和(he)创(chuang)(chuang)新(xin)并重，最大程度释(shi)放中(zhong)药(yao)(yao)(yao)创(chuang)(chuang)新(xin)潜能，将中(zhong)医学的(de)整体观念、人用经(jing)(jing)验(yan)、复方用药(yao)(yao)(yao)等优势和(he)特色融入到中(zhong)药(yao)(yao)(yao)注(zhu)(zhu)册(ce)管理之中(zhong)，使中(zhong)药(yao)(yao)(yao)研(yan)发能更好地体现中(zhong)药(yao)(yao)(yao)特点，把“安全、有(you)(you)效(xiao)、质量可控(kong)”的(de)药(yao)(yao)(yao)品一般要求(qiu)(qiu)与中(zhong)医药(yao)(yao)(yao)传承(cheng)创(chuang)(chuang)新(xin)发展(zhan)独特的(de)理论体系和(he)实(shi)践特点有(you)(you)机结(jie)合，开辟了(le)(le)具有(you)(you)中(zhong)医药(yao)(yao)(yao)特色的(de)注(zhu)(zhu)册(ce)审(shen)评路径。
其一，传(chuan)承古(gu)典(dian)(dian)医籍精华，促进(jin)中(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)的(de)(de)转化(hua)。中(zhong)(zhong)药(yao)(yao)有(you)(you)数千年临床用(yong)药(yao)(yao)经(jing)(jing)验(yan)，经(jing)(jing)典(dian)(dian)名方(fang)是(shi)临床组(zu)方(fang)用(yong)药(yao)(yao)的(de)(de)基础，也是(shi)中(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)创(chuang)制的(de)(de)源泉，具有(you)(you)特(te)有(you)(you)的(de)(de)原(yuan)创(chuang)思维，应该重视发(fa)掘(jue)古(gu)代文献和临床用(yong)药(yao)(yao)经(jing)(jing)验(yan)。中(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)的(de)(de)研发(fa)与化(hua)学药(yao)(yao)研发(fa)模式显(xian)著不(bu)同。《注册分类(lei)》新(xin)增“古(gu)代经(jing)(jing)典(dian)(dian)名方(fang)中(zhong)(zhong)药(yao)(yao)复(fu)方(fang)制剂(ji)”注册分类(lei)，不(bu)仅(jin)发(fa)挥中(zhong)(zhong)医药(yao)(yao)原(yuan)创(chuang)优势，还促进(jin)古(gu)代经(jing)(jing)典(dian)(dian)名方(fang)向(xiang)中(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)转化(hua)，形成自身独特(te)的(de)(de)原(yuan)创(chuang)性成果，将是(shi)对(dui)我国和世界人(ren)民(min)的(de)(de)重大贡献。
其二，以(yi)临(lin)(lin)床(chuang)价值传(chuan)承为(wei)基础(chu)，重(zhong)视人用(yong)(yong)经验证据(ju)(ju)收集。中(zhong)(zhong)(zhong)(zhong)药人用(yong)(yong)经验是在(zai)长期的(de)(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)医(yi)临(lin)(lin)床(chuang)实(shi)践当中(zhong)(zhong)(zhong)(zhong)形成的(de)(de)(de)(de)，具(ju)有(you)一定的(de)(de)(de)(de)规(gui)律性(xing)(xing)(xing)(xing)、可重(zhong)复性(xing)(xing)(xing)(xing)。关于中(zhong)(zhong)(zhong)(zhong)医(yi)及诊疗的(de)(de)(de)(de)经验总结，本身也是中(zhong)(zhong)(zhong)(zhong)医(yi)药的(de)(de)(de)(de)特点。新《注(zhu)册(ce)分类(lei)》注(zhu)重(zhong)满足尚未满足的(de)(de)(de)(de)临(lin)(lin)床(chuang)需求，立足于传(chuan)统中(zhong)(zhong)(zhong)(zhong)医(yi)理(li)论(lun)和中(zhong)(zhong)(zhong)(zhong)医(yi)临(lin)(lin)床(chuang)实(shi)践经验相结合评(ping)价中(zhong)(zhong)(zhong)(zhong)药的(de)(de)(de)(de)有(you)效性(xing)(xing)(xing)(xing)，支持(chi)根(gen)据(ju)(ju)人用(yong)(yong)经验对药物安(an)全性(xing)(xing)(xing)(xing)、有(you)效性(xing)(xing)(xing)(xing)的(de)(de)(de)(de)支持(chi)程度，科(ke)学合理(li)减免相应(ying)的(de)(de)(de)(de)申报资(zi)料，最(zui)大程度将中(zhong)(zhong)(zhong)(zhong)药最(zui)具(ju)优势的(de)(de)(de)(de)临(lin)(lin)床(chuang)实(shi)践应(ying)用(yong)(yong)于中(zhong)(zhong)(zhong)(zhong)药审评(ping)审批，中(zhong)(zhong)(zhong)(zhong)医(yi)临(lin)(lin)床(chuang)实(shi)践总结将在(zai)中(zhong)(zhong)(zhong)(zhong)药新药注(zhu)册(ce)审评(ping)中(zhong)(zhong)(zhong)(zhong)作用(yong)(yong)日(ri)益显现(xian)。
中(zhong)药(yao)(yao)创(chuang)新药(yao)(yao)，上市前应当进行(xing)随机对照临床试验。对于古代经典名方(fang)中(zhong)药(yao)(yao)复方(fang)制(zhi)剂(ji)，从(cong)中(zhong)医(yi)理论的(de)视(shi)角来(lai)审评审批中(zhong)药(yao)(yao)新药(yao)(yao)，功(gong)能主(zhu)治采(cai)用中(zhong)医(yi)术(shu)语表(biao)述，从(cong)而开辟了(le)具有中(zhong)医(yi)药(yao)(yao)特色的(de)申报路(lu)径，丰富了(le)中(zhong)药(yao)(yao)新药(yao)(yao)研制(zhi)的(de)实践。
其(qi)三，尊重中(zhong)(zhong)药(yao)(yao)(yao)研发规(gui)律(lv)，支持中(zhong)(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)制剂研发。中(zhong)(zhong)药(yao)(yao)(yao)方(fang)(fang)剂通过多(duo)种有效(xiao)组(zu)分对(dui)(dui)机(ji)体多(duo)系统、多(duo)途径、多(duo)靶点的综合调节，具(ju)有整体观念、辨证论(lun)治、因人施治、复(fu)方(fang)(fang)用(yong)药(yao)(yao)(yao)等诊疗(liao)优势(shi)和(he)特色(se)，《注册分类》遵循中(zhong)(zhong)医药(yao)(yao)(yao)发展规(gui)律(lv)，突出中(zhong)(zhong)药(yao)(yao)(yao)特色(se)，基于注册中(zhong)(zhong)药(yao)(yao)(yao)的产品特性(xing)、创新程度(du)和(he)审评管理(li)需要，对(dui)(dui)中(zhong)(zhong)药(yao)(yao)(yao)注册分类进行(xing)了优化。
其(qi)四，注(zhu)(zhu)重(zhong)“老(lao)药(yao)”临(lin)(lin)床(chuang)价(jia)值(zhi)挖掘，鼓励(li)二次开(kai)发。新(xin)药(yao)开(kai)发是(shi)以产品上市为目标、更重(zhong)视(shi)药(yao)物临(lin)(lin)床(chuang)价(jia)值(zhi)的(de)(de)创造(zao)，是(shi)从(cong)无到有的(de)(de)过(guo)程(cheng)。鼓励(li)二次开(kai)发则是(shi)在处方、功(gong)能主治都(dou)已固定的(de)(de)前提下基(ji)于临(lin)(lin)床(chuang)实践的(de)(de)价(jia)值(zhi)再(zai)塑，是(shi)一个从(cong)有到优的(de)(de)过(guo)程(cheng)。临(lin)(lin)床(chuang)价(jia)值(zhi)的(de)(de)挖掘、临(lin)(lin)床(chuang)定位塑造(zao)和临(lin)(lin)床(chuang)价(jia)值(zhi)提升(sheng)等(deng)工作是(shi)药(yao)物价(jia)值(zhi)再(zai)塑过(guo)程(cheng)的(de)(de)核心内容。《注(zhu)(zhu)册分(fen)类(lei)》拓(tuo)宽了改(gai)良型新(xin)药(yao)范畴，鼓励(li)药(yao)品上市许(xu)可持有人对已上市中(zhong)药(yao)开(kai)展研究，推动已上市中(zhong)药(yao)的(de)(de)改(gai)良与(yu)质量提升(sheng)，促(cu)进中(zhong)药(yao)产业高质量发展。不仅为中(zhong)医药(yao)走向世(shi)界(jie)打(da)下坚实基(ji)础，也为中(zhong)国医药(yao)创新(xin)开(kai)辟出了新(xin)领域。
通过政府部门引导(dao)，建(jian)立起以临床疗效为导(dao)向、以中(zhong)药新(xin)药研(yan)(yan)发(fa)(fa)项目(mu)为纽(niu)带、产学研(yan)(yan)医相互结合的中(zhong)药创新(xin)合作平(ping)台，可提高(gao)研(yan)(yan)发(fa)(fa)质量(liang)与研(yan)(yan)发(fa)(fa)成功率，加(jia)快(kuai)中(zhong)药新(xin)药的研(yan)(yan)发(fa)(fa)，促进中(zhong)药产业高(gao)质量(liang)发(fa)(fa)展。（中(zhong)国科(ke)学院(yuan)院(yuan)士 陈凯(kai)先）
