国家药监局关于促进中药传承创新发展的实施意见

时间:2019-12-25

各省(sheng)、自治区、直辖市药品监督管理(li)(li)局,新疆生(sheng)产建设兵团药品监督管理(li)(li)局,局机关各司局,各直属单(dan)位:

中(zhong)药(yao)是(shi)中(zhong)华民(min)族的(de)(de)瑰(gui)宝(bao),为(wei)(wei)造福人民(min)健(jian)康作出(chu)(chu)巨(ju)大贡(gong)献(xian),特(te)(te)(te)别(bie)是(shi)新(xin)(xin)冠(guan)肺炎疫情爆发(fa)以来(lai),中(zhong)药(yao)彰显特(te)(te)(te)色优(you)势,为(wei)(wei)打赢疫情防控阻击战(zhan)发(fa)挥了(le)(le)重要(yao)作用。党中(zhong)央(yang)国(guo)务院高度(du)重视中(zhong)医药(yao)工作,特(te)(te)(te)别(bie)是(shi)党的(de)(de)十(shi)八大以来(lai),习(xi)近平总书记(ji)多次(ci)作出(chu)(chu)重要(yao)指示批示,要(yao)求改革完(wan)善中(zhong)药(yao)审评(ping)审批机制,为(wei)(wei)新(xin)(xin)时(shi)代中(zhong)药(yao)传(chuan)(chuan)承(cheng)创(chuang)新(xin)(xin)发(fa)展指明了(le)(le)方向(xiang)、提供了(le)(le)遵循。为(wei)(wei)进一步贯彻习(xi)近平总书记(ji)系(xi)列重要(yao)指示批示精神,深入落实中(zhong)共中(zhong)央(yang)、国(guo)务院《关(guan)于(yu)促进中(zhong)医药(yao)传(chuan)(chuan)承(cheng)创(chuang)新(xin)(xin)发(fa)展的(de)(de)意见》决策部(bu)署,结(jie)合药(yao)品监管工作实际,提出(chu)(chu)以下意见。

一(yi)、指(zhi)导(dao)思想

以(yi)习近平(ping)新(xin)时代中(zhong)(zhong)(zhong)(zhong)(zhong)国特(te)(te)色社会(hui)主义思想(xiang)为指导,全面贯彻党的十(shi)九(jiu)大和十(shi)九(jiu)届二中(zhong)(zhong)(zhong)(zhong)(zhong)、三中(zhong)(zhong)(zhong)(zhong)(zhong)、四中(zhong)(zhong)(zhong)(zhong)(zhong)、五中(zhong)(zhong)(zhong)(zhong)(zhong)全会(hui)精神(shen),坚持(chi)以(yi)人民(min)为中(zhong)(zhong)(zhong)(zhong)(zhong)心的发(fa)展(zhan)(zhan)思想(xiang),全面落(luo)实“四个(ge)最严”的要求,促进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)药传(chuan)承创新(xin)发(fa)展(zhan)(zhan)。深化(hua)改革,健全符合中(zhong)(zhong)(zhong)(zhong)(zhong)药特(te)(te)点的审(shen)评(ping)审(shen)批体系。传(chuan)承精华,注(zhu)重(zhong)整体观和中(zhong)(zhong)(zhong)(zhong)(zhong)医药原创思维,促进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)药守(shou)正创新(xin)。坚守(shou)底线,强化(hua)中(zhong)(zhong)(zhong)(zhong)(zhong)药质量安全监管(guan)。创新(xin)发(fa)展(zhan)(zhan),推进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)药监管(guan)体系和监管(guan)能力现代化(hua)。

二、促进中药守正创(chuang)新

(一(yi))坚持以(yi)临(lin)(lin)床(chuang)价(jia)(jia)值(zhi)为(wei)(wei)导向。重(zhong)视根(gen)据中(zhong)(zhong)医药临(lin)(lin)床(chuang)治疗(liao)特(te)点(dian)(dian)和实际评(ping)(ping)估(gu)临(lin)(lin)床(chuang)价(jia)(jia)值(zhi),注(zhu)(zhu)重(zhong)满足尚未满足的临(lin)(lin)床(chuang)需求(qiu),制定(ding)(ding)中(zhong)(zhong)药新(xin)药临(lin)(lin)床(chuang)价(jia)(jia)值(zhi)评(ping)(ping)估(gu)技术指导原则。建立与中(zhong)(zhong)药临(lin)(lin)床(chuang)定(ding)(ding)位相适应、体现其作用(yong)特(te)点(dian)(dian)和优(you)势的疗(liao)效(xiao)评(ping)(ping)价(jia)(jia)标准。鼓励开(kai)展以(yi)患者为(wei)(wei)中(zhong)(zhong)心的疗(liao)效(xiao)评(ping)(ping)价(jia)(jia)。探索引入真实世界证据用(yong)于支(zhi)持中(zhong)(zhong)药新(xin)药注(zhu)(zhu)册(ce)上(shang)市(shi)。

(二(er))推(tui)动古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方中(zhong)药(yao)复(fu)方制(zhi)(zhi)剂(ji)(ji)研(yan)制(zhi)(zhi)。明确古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方中(zhong)药(yao)复(fu)方制(zhi)(zhi)剂(ji)(ji)研(yan)制(zhi)(zhi)有关技术要求,促进古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方中(zhong)药(yao)复(fu)方制(zhi)(zhi)剂(ji)(ji)研(yan)发,推(tui)进古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方向新(xin)药(yao)转化。会(hui)同国(guo)务(wu)院中(zhong)医药(yao)主管部门,建立(li)沟通协调(diao)机制(zhi)(zhi),组织研(yan)究(jiu)、制(zhi)(zhi)定古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方关键信息考证意(yi)见。建立(li)与(yu)古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方中(zhong)药(yao)复(fu)方制(zhi)(zhi)剂(ji)(ji)特点相(xiang)适应(ying)的审评模式,成立(li)古(gu)代(dai)(dai)经(jing)(jing)典名(ming)(ming)方中(zhong)药(yao)复(fu)方制(zhi)(zhi)剂(ji)(ji)专(zhuan)家审评委员会(hui),实(shi)施简化审批。

(三)促(cu)进中(zhong)药(yao)创(chuang)新(xin)(xin)发(fa)展(zhan)(zhan)。探索(suo)引入新(xin)(xin)工(gong)具、新(xin)(xin)方法(fa)、新(xin)(xin)技术、新(xin)(xin)标准用(yong)于中(zhong)药(yao)疗(liao)效评(ping)价(jia)。推动开展(zhan)(zhan)多(duo)区域(yu)临床试验规范性研(yan)究(jiu)能力与体(ti)系建设,促(cu)进中(zhong)药(yao)临床研(yan)究(jiu)质量(liang)整(zheng)体(ti)提(ti)升(sheng)。发(fa)挥医疗(liao)机(ji)(ji)构中(zhong)药(yao)制剂传承(cheng)创(chuang)新(xin)(xin)发(fa)展(zhan)(zhan)“孵化器”作用(yong),鼓励医疗(liao)机(ji)(ji)构制剂向中(zhong)药(yao)新(xin)(xin)药(yao)转(zhuan)化。支持(chi)以病(bing)证结(jie)合、专(zhuan)病(bing)专(zhuan)药(yao)或证候类(lei)中(zhong)药(yao)等多(duo)种(zhong)方式开展(zhan)(zhan)中(zhong)药(yao)新(xin)(xin)药(yao)研(yan)制。

(四(si))鼓励二(er)次开发。制定中(zhong)药(yao)(yao)改良型新(xin)药(yao)(yao)研究相关技(ji)术(shu)要求,支(zhi)持(chi)运用(yong)符(fu)合产品特点(dian)的(de)(de)新(xin)技(ji)术(shu)、新(xin)工艺以(yi)及(ji)体现临床应用(yong)优势(shi)和特点(dian)的(de)(de)新(xin)剂(ji)型改进(jin)已上市中(zhong)药(yao)(yao)品种(zhong)。支(zhi)持(chi)同名同方药(yao)(yao)的(de)(de)研制,促进(jin)已上市中(zhong)药(yao)(yao)同品种(zhong)的(de)(de)质(zhi)量竞(jing)争。优化(hua)已上市中(zhong)药(yao)(yao)变(bian)更相关技(ji)术(shu)要求。

(五)加强中(zhong)(zhong)药(yao)安(an)全性(xing)研(yan)究(jiu)。引导药(yao)品上(shang)(shang)市许可持有(you)人(ren)主动开(kai)(kai)展中(zhong)(zhong)药(yao)上(shang)(shang)市后研(yan)究(jiu)和上(shang)(shang)市后评价(jia)。建立符(fu)合中(zhong)(zhong)药(yao)特(te)点的安(an)全性(xing)评价(jia)方法(fa)和标(biao)准(zhun)(zhun)体系(xi),建立以中(zhong)(zhong)医(yi)临床(chuang)为导向的中(zhong)(zhong)药(yao)安(an)全性(xing)分类分级评价(jia)策略。加大对来(lai)源(yuan)于古代(dai)经典名(ming)方、名(ming)老中(zhong)(zhong)医(yi)验(yan)方、医(yi)疗机构制剂等具有(you)人(ren)用(yong)经验(yan)的中(zhong)(zhong)药(yao)新药(yao)安(an)全性(xing)评价(jia)技术标(biao)准(zhun)(zhun)的研(yan)究(jiu)。根据药(yao)物组方、人(ren)用(yong)经验(yan)、制备工艺、用(yong)法(fa)用(yong)量、功能主治特(te)点等,在(zai)临床(chuang)试验(yan)期间(jian)或上(shang)(shang)市后,开(kai)(kai)展各阶段相应(ying)的非(fei)临床(chuang)和临床(chuang)安(an)全性(xing)研(yan)究(jiu)。

三、健(jian)全符合中药特点的审评审批体系(xi)

(六)改革中(zhong)药(yao)注(zhu)册(ce)分类(lei)。尊重中(zhong)医(yi)药(yao)特(te)点(dian)(dian),遵循(xun)中(zhong)药(yao)研(yan)制规(gui)律,将“安全、有(you)效、质量可(ke)控(kong)”的药(yao)品基(ji)本(ben)要求(qiu)与中(zhong)医(yi)药(yao)传承创新发(fa)展独(du)特(te)的理(li)论体系和实(shi)(shi)践特(te)点(dian)(dian)有(you)机结合。根(gen)据中(zhong)药(yao)注(zhu)册(ce)产品特(te)性、创新程度和研(yan)制实(shi)(shi)践情况,改革中(zhong)药(yao)注(zhu)册(ce)分类(lei),不再仅(jin)以(yi)物(wu)质基(ji)础作为划分注(zhu)册(ce)类(lei)别的依据,开辟(pi)具有(you)中(zhong)医(yi)药(yao)特(te)色的注(zhu)册(ce)申报路径。

(七)构建(jian)“三结合”审(shen)评(ping)证据(ju)体系。进一步(bu)重视(shi)人用(yong)经验对(dui)中(zhong)(zhong)(zhong)药(yao)安(an)全性、有效性的支持作(zuo)用(yong),按照中(zhong)(zhong)(zhong)药(yao)特点、研发规律和实际(ji),构建(jian)中(zhong)(zhong)(zhong)医药(yao)理(li)论、人用(yong)经验和临床试验相结合的审(shen)评(ping)证据(ju)体系。加强(qiang)对(dui)人用(yong)经验的规范收集整理(li),规范申报资料要求。

(八)改革完善(shan)中(zhong)药(yao)(yao)审(shen)(shen)评审(shen)(shen)批制度。对临(lin)(lin)床(chuang)定(ding)位清晰且具有明显临(lin)(lin)床(chuang)价值,用于(yu)重大(da)(da)疾(ji)(ji)病(bing)、罕(han)见病(bing)防治(zhi)(zhi)、临(lin)(lin)床(chuang)急(ji)(ji)需而市场短缺、或(huo)属于(yu)儿童(tong)用药(yao)(yao)的(de)中(zhong)药(yao)(yao)新药(yao)(yao)申请实(shi)行优先审(shen)(shen)评审(shen)(shen)批。对治(zhi)(zhi)疗(liao)严(yan)重危及(ji)生命且尚(shang)无有效治(zhi)(zhi)疗(liao)手(shou)段的(de)疾(ji)(ji)病(bing)以及(ji)国(guo)务院卫生健(jian)康或(huo)中(zhong)医药(yao)(yao)主管部门认定(ding)为急(ji)(ji)需的(de)中(zhong)药(yao)(yao),药(yao)(yao)物临(lin)(lin)床(chuang)试验(yan)已(yi)有数(shu)据或(huo)高质量中(zhong)药(yao)(yao)人用经验(yan)证据显示疗(liao)效并能预(yu)测其临(lin)(lin)床(chuang)价值的(de),可以附(fu)条件批准(zhun)。对突发(fa)重大(da)(da)公(gong)共卫生事件中(zhong)应急(ji)(ji)所需的(de)已(yi)上市中(zhong)药(yao)(yao)增加功能主治(zhi)(zhi)实(shi)施特(te)别审(shen)(shen)批。

四、强化中药质量安全监管

(九)加(jia)(jia)(jia)强中(zhong)药(yao)质量源(yuan)(yuan)(yuan)(yuan)头管理(li)。修订中(zhong)药(yao)材(cai)(cai)生产(chan)(chan)质量管理(li)规(gui)(gui)范(fan)(GAP),制定中(zhong)药(yao)材(cai)(cai)生产(chan)(chan)质量管理(li)规(gui)(gui)范(fan)实(shi)施指南,引导促(cu)进(jin)中(zhong)药(yao)材(cai)(cai)规(gui)(gui)范(fan)化种植养殖,推(tui)动(dong)中(zhong)药(yao)材(cai)(cai)产(chan)(chan)地加(jia)(jia)(jia)工,鼓(gu)励中(zhong)药(yao)饮(yin)片企业将(jiang)质量保障体系向种植加(jia)(jia)(jia)工环节延(yan)伸,从源(yuan)(yuan)(yuan)(yuan)头加(jia)(jia)(jia)强中(zhong)药(yao)材(cai)(cai)、中(zhong)药(yao)饮(yin)片质量控(kong)制。加(jia)(jia)(jia)强和规(gui)(gui)范(fan)中(zhong)药(yao)新(xin)药(yao)用中(zhong)药(yao)材(cai)(cai)、中(zhong)药(yao)饮(yin)片的质量管理(li),明(ming)确质量控(kong)制研究(jiu)相关技(ji)术要求。保护野生药(yao)材(cai)(cai)资源(yuan)(yuan)(yuan)(yuan),严格限定使用濒危野生动(dong)、植物药(yao)材(cai)(cai)。加(jia)(jia)(jia)强开展(zhan)中(zhong)药(yao)新(xin)药(yao)资源(yuan)(yuan)(yuan)(yuan)评估,保障中(zhong)药(yao)材(cai)(cai)来源(yuan)(yuan)(yuan)(yuan)稳(wen)定和资源(yuan)(yuan)(yuan)(yuan)可持续利用。

(十(shi))加强生(sheng)产(chan)(chan)(chan)(chan)全过程(cheng)的(de)(de)质(zhi)(zhi)量(liang)(liang)控制(zhi)。加大飞(fei)行检(jian)查力度,严格执行药(yao)(yao)品生(sheng)产(chan)(chan)(chan)(chan)质(zhi)(zhi)量(liang)(liang)管理规(gui)范(GMP)。在(zai)传承中药(yao)(yao)饮片(pian)传统炮制(zhi)方法和经验基础上,修订药(yao)(yao)品生(sheng)产(chan)(chan)(chan)(chan)质(zhi)(zhi)量(liang)(liang)管理规(gui)范中药(yao)(yao)饮片(pian)附录。持续修订完善包括中药(yao)(yao)材、中药(yao)(yao)饮片(pian)、中间产(chan)(chan)(chan)(chan)品和制(zhi)剂等(deng)在(zai)内(nei)的(de)(de)完整的(de)(de)内(nei)控质(zhi)(zhi)量(liang)(liang)标(biao)准体系,保持药(yao)(yao)品批间质(zhi)(zhi)量(liang)(liang)稳定(ding)可(ke)控。推动中药(yao)(yao)制(zhi)药(yao)(yao)技(ji)术升级,鼓励生(sheng)产(chan)(chan)(chan)(chan)企业(ye)逐(zhu)步实现智能制(zhi)造。

(十一)加强(qiang)(qiang)上(shang)市(shi)(shi)(shi)后监(jian)(jian)管(guan)(guan)。组织中(zhong)(zhong)药(yao)(yao)专项检查,持续加大中(zhong)(zhong)成药(yao)(yao)和(he)中(zhong)(zhong)药(yao)(yao)饮(yin)(yin)片抽检力(li)度(du),持续排(pai)查化(hua)解风(feng)险(xian)隐患,依法(fa)处(chu)置(zhi)违(wei)法(fa)违(wei)规(gui)(gui)企业(ye)。聚焦掺杂使假、染色增重、非法(fa)添加、非法(fa)渠道(dao)购入中(zhong)(zhong)药(yao)(yao)饮(yin)(yin)片等(deng)问题,开展(zhan)中(zhong)(zhong)药(yao)(yao)饮(yin)(yin)片质(zhi)量(liang)集中(zhong)(zhong)整治(zhi),严(yan)厉(li)(li)打击违(wei)法(fa)违(wei)规(gui)(gui)行(xing)为。推(tui)动地方政(zheng)府落实地方监(jian)(jian)管(guan)(guan)责(ze)任,加强(qiang)(qiang)对(dui)中(zhong)(zhong)药(yao)(yao)材(cai)交易市(shi)(shi)(shi)场(chang)(chang)的(de)监(jian)(jian)管(guan)(guan),严(yan)厉(li)(li)打击无证(zheng)销售中(zhong)(zhong)药(yao)(yao)饮(yin)(yin)片行(xing)为,持续净化(hua)市(shi)(shi)(shi)场(chang)(chang)秩(zhi)序。基(ji)于中(zhong)(zhong)医药(yao)(yao)发展(zhan)实际,研(yan)究完善(shan)按照(zhao)省(sheng)级饮(yin)(yin)片炮制(zhi)规(gui)(gui)范(fan)生产中(zhong)(zhong)药(yao)(yao)饮(yin)(yin)片的(de)流通政(zheng)策。强(qiang)(qiang)化(hua)中(zhong)(zhong)药(yao)(yao)不良反应(ying)(ying)监(jian)(jian)测,对(dui)监(jian)(jian)测中(zhong)(zhong)发现(xian)的(de)风(feng)险(xian)信号及(ji)时组织评估并(bing)采取(qu)风(feng)险(xian)控制(zhi)措施。加强(qiang)(qiang)中(zhong)(zhong)药(yao)(yao)说(shuo)明书和(he)标签管(guan)(guan)理,推(tui)进对(dui)已(yi)上(shang)市(shi)(shi)(shi)中(zhong)(zhong)药(yao)(yao)说(shuo)明书中(zhong)(zhong)【禁忌】【不良反应(ying)(ying)】【注(zhu)意事项】等(deng)相关内容的(de)修改完善(shan)。

(十二)加大保(bao)(bao)护(hu)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)品(pin)(pin)种力度。修订《中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)品(pin)(pin)种保(bao)(bao)护(hu)条例》,将中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)品(pin)(pin)种保(bao)(bao)护(hu)制度与专(zhuan)利保(bao)(bao)护(hu)制度有机衔接,并纳入中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)全生命周期注(zhu)册管理(li)之中(zhong)(zhong)(zhong)(zhong),发挥其对中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)创新药(yao)(yao)(yao)、中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)改良型新药(yao)(yao)(yao)以(yi)及(ji)古代经(jing)典名(ming)方中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)复方制剂等中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)品(pin)(pin)种的保(bao)(bao)护(hu)作用。支持药(yao)(yao)(yao)品(pin)(pin)上市许可持有人(ren)或申请(qing)人(ren)按有关规定进行相关专(zhuan)利信息的登记(ji)、声明。

五、注重多(duo)方协(xie)调联(lian)动

(十三(san))加强横(heng)向联系。积(ji)极(ji)按照(zhao)国务院中(zhong)医药(yao)工作部(bu)(bu)际联席会议部(bu)(bu)署,加强与科(ke)技、卫生健康(kang)、中(zhong)医药(yao)、医保等部(bu)(bu)门的(de)沟通协调(diao),形成(cheng)部(bu)(bu)门工作合力,推进(jin)国家重大(da)科(ke)技项目(mu)的(de)成(cheng)果转化,满足临床需求,积(ji)极(ji)服务中(zhong)药(yao)产业高(gao)质量发展。

(十(shi)四)督促(cu)落实(shi)各方责(ze)任(ren)。压实(shi)企(qi)(qi)业(ye)主体(ti)责(ze)任(ren),督促(cu)企(qi)(qi)业(ye)牢(lao)固树立质量(liang)安全(quan)(quan)第一责(ze)任(ren)人意识,履行药(yao)(yao)品(pin)全(quan)(quan)生命(ming)周期管理(li)责(ze)任(ren),推进(jin)中药(yao)(yao)企(qi)(qi)业(ye)诚信(xin)体(ti)系(xi)建设。全(quan)(quan)面落实(shi)“四个最严”的要求,切实(shi)承担起药(yao)(yao)品(pin)监管责(ze)任(ren),牢(lao)牢(lao)守(shou)住(zhu)药(yao)(yao)品(pin)安全(quan)(quan)底线。推动地(di)方党委政府扛起药(yao)(yao)品(pin)安全(quan)(quan)政治责(ze)任(ren),强(qiang)化属地(di)管理(li)责(ze)任(ren)。

(十五(wu))营造良好社(she)会(hui)氛(fen)围。加大中(zhong)药审(shen)评审(shen)批改革宣(xuan)传力度,加强(qiang)重要政策(ce)、重大措施解读,及时回应社(she)会(hui)关(guan)切,合理引导各(ge)方(fang)预(yu)期(qi),推(tui)动形(xing)成全社(she)会(hui)共同参与中(zhong)药传承创新(xin)(xin)的新(xin)(xin)格局。

六、推进(jin)中药监管(guan)(guan)体系和监管(guan)(guan)能力现(xian)代化(hua)

(十六)完善(shan)中(zhong)药(yao)(yao)(yao)法(fa)规(gui)标(biao)(biao)准(zhun)体系。加(jia)快《药(yao)(yao)(yao)品(pin)(pin)管(guan)(guan)理法(fa)》《中(zhong)医(yi)药(yao)(yao)(yao)法(fa)》相关配套规(gui)章制度(du)建设,健(jian)全完善(shan)中(zhong)药(yao)(yao)(yao)全生命周(zhou)期(qi)监管(guan)(guan)制度(du)体系。加(jia)强中(zhong)药(yao)(yao)(yao)标(biao)(biao)准(zhun)管(guan)(guan)理,优化国家(jia)药(yao)(yao)(yao)品(pin)(pin)标(biao)(biao)准(zhun)形成机(ji)制,持(chi)续完善(shan)以《中(zhong)国药(yao)(yao)(yao)典》为核心(xin)的(de)国家(jia)药(yao)(yao)(yao)品(pin)(pin)标(biao)(biao)准(zhun)体系。建立和完善(shan)以临(lin)床为导(dao)向、符合中(zhong)医(yi)药(yao)(yao)(yao)特点的(de)中(zhong)药(yao)(yao)(yao)质(zhi)量(liang)标(biao)(biao)准(zhun)、技术规(gui)范(fan)和评价体系,全面客(ke)观反映(ying)中(zhong)药(yao)(yao)(yao)质(zhi)量(liang)。研究完善(shan)中(zhong)药(yao)(yao)(yao)材(cai)中(zhong)农药(yao)(yao)(yao)残留、重金属与有害元素(su)、真菌(jun)毒素(su)等(deng)有害物质(zhi)限量(liang)要(yao)求和检测方法(fa)。制定实施(shi)(shi)全国中(zhong)药(yao)(yao)(yao)饮片炮制规(gui)范(fan)。加(jia)强地方药(yao)(yao)(yao)材(cai)标(biao)(biao)准(zhun)和省级饮片炮制规(gui)范(fan)的(de)监督实施(shi)(shi)。

(十七(qi))强(qiang)化(hua)技术(shu)支撑体(ti)系建(jian)(jian)设。以编制“十四(si)五”药(yao)(yao)(yao)品(pin)安全(quan)及高(gao)质量发展规划(hua)为(wei)契机,开展重点课题(ti)研究,加强(qiang)检验检测、审评审批、审核查(cha)验、监(jian)测评价等重点技术(shu)支撑机构建(jian)(jian)设。加强(qiang)“智慧(hui)监(jian)管”建(jian)(jian)设,创新利用大数据(ju)、互联网、云计算等现代信息技术(shu),推(tui)进(jin)药(yao)(yao)(yao)品(pin)追(zhui)溯(su)信息互通(tong)互享(xiang)。推(tui)动相关(guan)部(bu)门共同开展中药(yao)(yao)(yao)材(cai)信息化(hua)追(zhui)溯(su)体(ti)系建(jian)(jian)设,进(jin)一步(bu)提高(gao)中药(yao)(yao)(yao)材(cai)质量安全(quan)保障水平。稳(wen)步(bu)推(tui)进(jin)中药(yao)(yao)(yao)生产企业(ye)建(jian)(jian)立药(yao)(yao)(yao)品(pin)追(zhui)溯(su)体(ti)系,对中药(yao)(yao)(yao)产品(pin)赋码、扫码,逐步(bu)在药(yao)(yao)(yao)品(pin)生产流(liu)通(tong)全(quan)过(guo)程实现可追(zhui)溯(su)。

(十八)加强中药(yao)(yao)(yao)监管(guan)科(ke)学研究(jiu)(jiu)。鼓励运用(yong)现代科(ke)学技术(shu)和传统(tong)中医(yi)药(yao)(yao)(yao)研究(jiu)(jiu)方(fang)法(fa),深入(ru)开(kai)展中药(yao)(yao)(yao)监管(guan)科(ke)学研究(jiu)(jiu),积极推(tui)动中药(yao)(yao)(yao)监管(guan)理念、制(zhi)度、机(ji)制(zhi)创新(xin),强化(hua)成(cheng)果转化(hua)应用(yong),推(tui)出(chu)一批中药(yao)(yao)(yao)监管(guan)新(xin)工具、新(xin)方(fang)法(fa)和新(xin)标准。深化(hua)与国内(nei)一流大学、科(ke)研机(ji)构(gou)之间合(he)作,建立(li)中药(yao)(yao)(yao)监管(guan)科(ke)学合(he)作研究(jiu)(jiu)基(ji)地和国家(jia)药(yao)(yao)(yao)监局(ju)重点(dian)实验(yan)室,强化(hua)中药(yao)(yao)(yao)监管(guan)基(ji)础性、战(zhan)略性问题(ti)研究(jiu)(jiu)。

(十九)加强监(jian)管队(dui)(dui)伍建(jian)设(she)。加快职(zhi)(zhi)业化、专业化的中药审评员、检查员队(dui)(dui)伍建(jian)设(she),完(wan)善分级(ji)分类(lei)管理制(zhi)度(du),明确岗位准(zhun)入和任职(zhi)(zhi)条件。科学合理开展中药专业人员的考核评价和职(zhi)(zhi)级(ji)升降,扩宽职(zhi)(zhi)业发展空间,完(wan)善薪酬待遇保障机(ji)制(zhi),确保高层(ceng)次人才(cai)“招得来(lai)、留(liu)得住”。  

(二十)积(ji)(ji)极推动(dong)国(guo)(guo)(guo)际(ji)(ji)传统(tong)药(yao)(yao)监(jian)(jian)管(guan)(guan)合作(zuo)(zuo)。深化与世界卫生(sheng)组织(zhi)(zhi)(zhi)(WHO)合作(zuo)(zuo),积(ji)(ji)极开展与国(guo)(guo)(guo)际(ji)(ji)草药(yao)(yao)监(jian)(jian)管(guan)(guan)合作(zuo)(zuo)组织(zhi)(zhi)(zhi)(IRCH)、西太(tai)区(qu)草药(yao)(yao)监(jian)(jian)管(guan)(guan)协调(diao)论坛(FHH)等传统(tong)药(yao)(yao)监(jian)(jian)管(guan)(guan)国(guo)(guo)(guo)际(ji)(ji)组织(zhi)(zhi)(zhi)以及有关国(guo)(guo)(guo)家或地区(qu)药(yao)(yao)品监(jian)(jian)管(guan)(guan)、药(yao)(yao)典(dian)机构的交(jiao)流,深入参与国(guo)(guo)(guo)际(ji)(ji)传统(tong)药(yao)(yao)相关政策规则制定、标准(zhun)协调(diao),推动(dong)中药(yao)(yao)标准(zhun)国(guo)(guo)(guo)际(ji)(ji)化。持续(xu)提升(sheng)我国(guo)(guo)(guo)中药(yao)(yao)监(jian)(jian)管(guan)(guan)在国(guo)(guo)(guo)际(ji)(ji)监(jian)(jian)管(guan)(guan)组织(zhi)(zhi)(zhi)中的话语权,推动(dong)中医药(yao)(yao)更好地为全世界人民服务。

  

 

 


                                                                                 国家药监局                  

                                                                          2020年12月21日                

 

来源:国家药品监督管理局网站