党中(zhong)(zhong)(zhong)(zhong)央国务院(yuan)高度重视中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)事(shi)业，将中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)定位(wei)为(wei)独特的(de)(de)卫(wei)生资(zi)源(yuan)、潜力巨大的(de)(de)经(jing)济(ji)资(zi)源(yuan)、具有原创优(you)势(shi)的(de)(de)科(ke)技资(zi)源(yuan)、优(you)秀的(de)(de)文化资(zi)源(yuan)和重要的(de)(de)生态资(zi)源(yuan)。习近平(ping)总书(shu)记对中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)工作(zuo)多(duo)次作(zuo)出重要指示，强调要遵(zun)循(xun)中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)发展规律，传承精华、守正创新(xin)，充分发挥(hui)中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)防病(bing)治病(bing)的(de)(de)独特优(you)势(shi)和作(zuo)用。
新冠肺炎疫情暴发(fa)(fa)以来，中(zhong)医(yi)药(yao)(yao)(yao)(yao)在抗(kang)击(ji)疫情中(zhong)彰显(xian)特色优(you)(you)势(shi)，为人类(lei)健康贡献中(zhong)国智慧和(he)中(zhong)医(yi)药(yao)(yao)(yao)(yao)方(fang)案(an)。如何有效、充分地开发(fa)(fa)利用中(zhong)医(yi)药(yao)(yao)(yao)(yao)这一(yi)具(ju)有独特优(you)(you)势(shi)的(de)原创资源，是中(zhong)医(yi)药(yao)(yao)(yao)(yao)工作(zuo)(zuo)者(zhe)必须深入(ru)思考和(he)解决的(de)关(guan)键问题。中(zhong)药(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)研究也是中(zhong)医(yi)药(yao)(yao)(yao)(yao)发(fa)(fa)展的(de)重要(yao)领(ling)域，充满挑战，值得广大科研工作(zuo)(zuo)者(zhe)为之努力。中(zhong)药(yao)(yao)(yao)(yao)的(de)研发(fa)(fa)要(yao)遵循(xun)中(zhong)药(yao)(yao)(yao)(yao)特点及(ji)研究规律，要(yao)坚持(chi)中(zhong)医(yi)药(yao)(yao)(yao)(yao)理论指导，注重整(zheng)体观及(ji)中(zhong)医(yi)药(yao)(yao)(yao)(yao)的(de)原创思维，注重临床实(shi)践(jian)基(ji)础，发(fa)(fa)挥中(zhong)医(yi)药(yao)(yao)(yao)(yao)防病治(zhi)病的(de)独特优(you)(you)势(shi)和(he)作(zuo)(zuo)用。
2020年9月(yue)28日，国(guo)家药(yao)(yao)(yao)监局发布了(le)(le)新的(de)《中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)注(zhu)册分类及(ji)申(shen)报资料要(yao)求(qiu)》（简称《注(zhu)册分类》）。《注(zhu)册分类》深(shen)刻总结了(le)(le)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)审(shen)评审(shen)批实(shi)践(jian)经验，将中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)传(chuan)承和(he)创新并重，最大(da)程度(du)释放(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)创新潜能，将中(zhong)(zhong)(zhong)(zhong)医(yi)(yi)学的(de)整体(ti)观(guan)念、人用经验、复方用药(yao)(yao)(yao)等优势和(he)特(te)色(se)融入到中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)注(zhu)册管理之中(zhong)(zhong)(zhong)(zhong)，使中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)研发能更好地体(ti)现中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)特(te)点，把“安(an)全、有(you)效、质(zhi)量可控”的(de)药(yao)(yao)(yao)品一般要(yao)求(qiu)与中(zhong)(zhong)(zhong)(zhong)医(yi)(yi)药(yao)(yao)(yao)传(chuan)承创新发展独特(te)的(de)理论(lun)体(ti)系和(he)实(shi)践(jian)特(te)点有(you)机结合，开辟了(le)(le)具有(you)中(zhong)(zhong)(zhong)(zhong)医(yi)(yi)药(yao)(yao)(yao)特(te)色(se)的(de)注(zhu)册审(shen)评路径。
其(qi)一，传(chuan)承(cheng)古(gu)典(dian)医籍精华，促进中药(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)的(de)转化。中药(yao)(yao)(yao)(yao)(yao)有数千年临(lin)(lin)床用药(yao)(yao)(yao)(yao)(yao)经(jing)验，经(jing)典(dian)名(ming)方(fang)是(shi)临(lin)(lin)床组(zu)方(fang)用药(yao)(yao)(yao)(yao)(yao)的(de)基础，也(ye)是(shi)中药(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)创制(zhi)的(de)源(yuan)泉(quan)，具有特(te)有的(de)原(yuan)创思维，应该(gai)重视发掘古(gu)代文献(xian)和临(lin)(lin)床用药(yao)(yao)(yao)(yao)(yao)经(jing)验。中药(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)的(de)研(yan)发与(yu)化学药(yao)(yao)(yao)(yao)(yao)研(yan)发模式显著不同(tong)。《注册分类》新(xin)增“古(gu)代经(jing)典(dian)名(ming)方(fang)中药(yao)(yao)(yao)(yao)(yao)复方(fang)制(zhi)剂”注册分类，不仅(jin)发挥中医药(yao)(yao)(yao)(yao)(yao)原(yuan)创优势，还促进古(gu)代经(jing)典(dian)名(ming)方(fang)向中药(yao)(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)(yao)转化，形成(cheng)(cheng)自身独特(te)的(de)原(yuan)创性成(cheng)(cheng)果(guo)，将(jiang)是(shi)对我(wo)国和世界人民的(de)重大贡献(xian)。
其二，以临床(chuang)(chuang)(chuang)价(jia)值传承(cheng)为(wei)基础，重(zhong)视(shi)人(ren)用经(jing)验(yan)证据收集。中(zhong)(zhong)药(yao)(yao)人(ren)用经(jing)验(yan)是(shi)(shi)在(zai)长期的(de)(de)中(zhong)(zhong)医(yi)临床(chuang)(chuang)(chuang)实(shi)践(jian)当(dang)中(zhong)(zhong)形(xing)成的(de)(de)，具有(you)一定的(de)(de)规律性(xing)、可重(zhong)复性(xing)。关于中(zhong)(zhong)医(yi)及诊疗的(de)(de)经(jing)验(yan)总结(jie)，本身也(ye)是(shi)(shi)中(zhong)(zhong)医(yi)药(yao)(yao)的(de)(de)特(te)点。新《注(zhu)册分(fen)类》注(zhu)重(zhong)满足(zu)尚(shang)未(wei)满足(zu)的(de)(de)临床(chuang)(chuang)(chuang)需求，立足(zu)于传统中(zhong)(zhong)医(yi)理(li)论和中(zhong)(zhong)医(yi)临床(chuang)(chuang)(chuang)实(shi)践(jian)经(jing)验(yan)相结(jie)合(he)评价(jia)中(zhong)(zhong)药(yao)(yao)的(de)(de)有(you)效(xiao)性(xing)，支(zhi)持(chi)根(gen)据人(ren)用经(jing)验(yan)对药(yao)(yao)物安(an)全性(xing)、有(you)效(xiao)性(xing)的(de)(de)支(zhi)持(chi)程度(du)，科(ke)学合(he)理(li)减免相应(ying)(ying)的(de)(de)申(shen)报资料(liao)，最大程度(du)将中(zhong)(zhong)药(yao)(yao)最具优势的(de)(de)临床(chuang)(chuang)(chuang)实(shi)践(jian)应(ying)(ying)用于中(zhong)(zhong)药(yao)(yao)审评审批，中(zhong)(zhong)医(yi)临床(chuang)(chuang)(chuang)实(shi)践(jian)总结(jie)将在(zai)中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)注(zhu)册审评中(zhong)(zhong)作用日益显现(xian)。
中(zhong)药(yao)(yao)创新(xin)药(yao)(yao)，上(shang)市(shi)前应当进行随机对(dui)照临床试验。对(dui)于(yu)古代经典(dian)名方(fang)(fang)中(zhong)药(yao)(yao)复方(fang)(fang)制(zhi)剂(ji)，从中(zhong)医(yi)理论的(de)(de)(de)视角来审(shen)评审(shen)批(pi)中(zhong)药(yao)(yao)新(xin)药(yao)(yao)，功能主治(zhi)采(cai)用中(zhong)医(yi)术语(yu)表(biao)述，从而开辟了具有中(zhong)医(yi)药(yao)(yao)特色的(de)(de)(de)申报路径，丰富了中(zhong)药(yao)(yao)新(xin)药(yao)(yao)研(yan)制(zhi)的(de)(de)(de)实(shi)践。
其(qi)三，尊(zun)重(zhong)中(zhong)(zhong)药(yao)(yao)研(yan)发规律，支持中(zhong)(zhong)药(yao)(yao)复方(fang)制剂研(yan)发。中(zhong)(zhong)药(yao)(yao)方(fang)剂通过多(duo)(duo)种有效组(zu)分对(dui)(dui)机体多(duo)(duo)系统、多(duo)(duo)途径、多(duo)(duo)靶点的(de)综合调节，具有整体观念(nian)、辨证论治、因人施治、复方(fang)用药(yao)(yao)等诊疗优势和特色(se)，《注册分类(lei)》遵(zun)循(xun)中(zhong)(zhong)医(yi)药(yao)(yao)发展规律，突出中(zhong)(zhong)药(yao)(yao)特色(se)，基于(yu)注册中(zhong)(zhong)药(yao)(yao)的(de)产品特性、创新程度和审评管理(li)需要，对(dui)(dui)中(zhong)(zhong)药(yao)(yao)注册分类(lei)进行了(le)优化。
其(qi)四(si)，注重“老药(yao)”临床(chuang)价(jia)值(zhi)(zhi)挖掘，鼓(gu)励(li)二(er)(er)次开发(fa)(fa)(fa)。新(xin)药(yao)开发(fa)(fa)(fa)是(shi)(shi)(shi)以(yi)产(chan)品上市(shi)为(wei)目(mu)标、更重视药(yao)物临床(chuang)价(jia)值(zhi)(zhi)的(de)创造，是(shi)(shi)(shi)从(cong)(cong)无到(dao)有的(de)过(guo)程(cheng)(cheng)。鼓(gu)励(li)二(er)(er)次开发(fa)(fa)(fa)则是(shi)(shi)(shi)在处方、功能(neng)主治(zhi)都已固定的(de)前提下(xia)基于临床(chuang)实(shi)践的(de)价(jia)值(zhi)(zhi)再塑，是(shi)(shi)(shi)一个从(cong)(cong)有到(dao)优的(de)过(guo)程(cheng)(cheng)。临床(chuang)价(jia)值(zhi)(zhi)的(de)挖掘、临床(chuang)定位(wei)塑造和临床(chuang)价(jia)值(zhi)(zhi)提升等工(gong)作是(shi)(shi)(shi)药(yao)物价(jia)值(zhi)(zhi)再塑过(guo)程(cheng)(cheng)的(de)核心内(nei)容。《注册分类》拓宽了改(gai)良(liang)型新(xin)药(yao)范畴，鼓(gu)励(li)药(yao)品上市(shi)许可持有人对(dui)已上市(shi)中(zhong)药(yao)开展研(yan)究(jiu)，推动已上市(shi)中(zhong)药(yao)的(de)改(gai)良(liang)与质量提升，促进中(zhong)药(yao)产(chan)业高质量发(fa)(fa)(fa)展。不(bu)仅为(wei)中(zhong)医(yi)药(yao)走向世界打(da)下(xia)坚实(shi)基础，也为(wei)中(zhong)国医(yi)药(yao)创新(xin)开辟出(chu)了新(xin)领(ling)域。
通过政府部(bu)门引导(dao)，建立起以临(lin)床疗效为(wei)导(dao)向、以中(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)研(yan)(yan)(yan)发(fa)(fa)(fa)项目为(wei)纽带、产学研(yan)(yan)(yan)医相互结合的(de)中(zhong)(zhong)药(yao)(yao)(yao)创新(xin)合作平(ping)台，可提高(gao)研(yan)(yan)(yan)发(fa)(fa)(fa)质量与研(yan)(yan)(yan)发(fa)(fa)(fa)成功率(lv)，加快中(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)的(de)研(yan)(yan)(yan)发(fa)(fa)(fa)，促进(jin)中(zhong)(zhong)药(yao)(yao)(yao)产业高(gao)质量发(fa)(fa)(fa)展。（中(zhong)(zhong)国科学院院士(shi) 陈凯先）
