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(ge)省、自治区、直辖市药品(pin)监督管理局(ju),新(xin)疆生产建设兵团药品(pin)监督管理局(ju),局(ju)机(ji)关各(ge)司局(ju),各(ge)直属(shu)单位:

中(zhong)(zhong)(zhong)药(yao)(yao)是(shi)中(zhong)(zhong)(zhong)华民(min)族的(de)瑰宝,为(wei)造福人民(min)健康(kang)作(zuo)(zuo)出巨大(da)贡献,特别是(shi)新(xin)冠肺炎(yan)疫情爆发以来,中(zhong)(zhong)(zhong)药(yao)(yao)彰显特色优势,为(wei)打赢疫情防(fang)控(kong)阻击战(zhan)发挥了重要(yao)作(zuo)(zuo)用(yong)。党(dang)中(zhong)(zhong)(zhong)央(yang)国(guo)(guo)务院高度重视(shi)中(zhong)(zhong)(zhong)医药(yao)(yao)工作(zuo)(zuo),特别是(shi)党(dang)的(de)十八大(da)以来,习近平总书(shu)记多(duo)次作(zuo)(zuo)出重要(yao)指示(shi)批示(shi),要(yao)求改革完善(shan)中(zhong)(zhong)(zhong)药(yao)(yao)审(shen)评审(shen)批机制,为(wei)新(xin)时(shi)代中(zhong)(zhong)(zhong)药(yao)(yao)传(chuan)承(cheng)创新(xin)发展指明了方(fang)向(xiang)、提供了遵(zun)循。为(wei)进(jin)一步贯彻(che)习近平总书(shu)记系列重要(yao)指示(shi)批示(shi)精神,深入落实中(zhong)(zhong)(zhong)共(gong)中(zhong)(zhong)(zhong)央(yang)、国(guo)(guo)务院《关于促进(jin)中(zhong)(zhong)(zhong)医药(yao)(yao)传(chuan)承(cheng)创新(xin)发展的(de)意(yi)见(jian)(jian)》决策部署,结合药(yao)(yao)品(pin)监管工作(zuo)(zuo)实际(ji),提出以下意(yi)见(jian)(jian)。

一(yi)、指导(dao)思(si)想

以习近平(ping)新(xin)时代中(zhong)国特色社会主义思想为指导,全(quan)(quan)面贯(guan)彻党的十九大和(he)十九届二中(zhong)、三中(zhong)、四中(zhong)、五中(zhong)全(quan)(quan)会精神,坚持(chi)以人民(min)为中(zhong)心(xin)的发展(zhan)思想,全(quan)(quan)面落(luo)实(shi)“四个(ge)最严”的要求,促(cu)进(jin)中(zhong)药传(chuan)承创(chuang)(chuang)新(xin)发展(zhan)。深化(hua)(hua)改革,健全(quan)(quan)符合中(zhong)药特点的审评审批体系(xi)。传(chuan)承精华,注重(zhong)整体观和(he)中(zhong)医药原创(chuang)(chuang)思维,促(cu)进(jin)中(zhong)药守正创(chuang)(chuang)新(xin)。坚守底线(xian),强化(hua)(hua)中(zhong)药质量安全(quan)(quan)监管(guan)。创(chuang)(chuang)新(xin)发展(zhan),推进(jin)中(zhong)药监管(guan)体系(xi)和(he)监管(guan)能力现代化(hua)(hua)。

二、促进中药守正创(chuang)新(xin)

(一)坚持以临(lin)(lin)床(chuang)(chuang)价值为(wei)导向。重视(shi)根据(ju)中(zhong)(zhong)医药(yao)临(lin)(lin)床(chuang)(chuang)治疗特点和实(shi)际(ji)评(ping)(ping)估(gu)临(lin)(lin)床(chuang)(chuang)价值,注重满(man)足(zu)尚(shang)未满(man)足(zu)的(de)临(lin)(lin)床(chuang)(chuang)需求,制定(ding)中(zhong)(zhong)药(yao)新药(yao)临(lin)(lin)床(chuang)(chuang)价值评(ping)(ping)估(gu)技术指(zhi)导原则。建(jian)立与(yu)中(zhong)(zhong)药(yao)临(lin)(lin)床(chuang)(chuang)定(ding)位(wei)相适(shi)应(ying)、体现其(qi)作用特点和优(you)势的(de)疗效(xiao)(xiao)评(ping)(ping)价标准。鼓励开展以患者为(wei)中(zhong)(zhong)心的(de)疗效(xiao)(xiao)评(ping)(ping)价。探索引(yin)入真实(shi)世界证据(ju)用于(yu)支持中(zhong)(zhong)药(yao)新药(yao)注册上(shang)市。

(二)推(tui)动古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)中(zhong)(zhong)(zhong)药(yao)复(fu)方(fang)(fang)制(zhi)(zhi)剂(ji)研(yan)制(zhi)(zhi)。明确(que)古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)中(zhong)(zhong)(zhong)药(yao)复(fu)方(fang)(fang)制(zhi)(zhi)剂(ji)研(yan)制(zhi)(zhi)有关技术要求(qiu),促(cu)进古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)中(zhong)(zhong)(zhong)药(yao)复(fu)方(fang)(fang)制(zhi)(zhi)剂(ji)研(yan)发,推(tui)进古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)向新药(yao)转化(hua)。会(hui)同国(guo)务院中(zhong)(zhong)(zhong)医药(yao)主管(guan)部门(men),建立沟(gou)通协调机制(zhi)(zhi),组织(zhi)研(yan)究(jiu)、制(zhi)(zhi)定古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)关键信(xin)息考证意见。建立与(yu)古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)中(zhong)(zhong)(zhong)药(yao)复(fu)方(fang)(fang)制(zhi)(zhi)剂(ji)特点相适应的(de)审评模式(shi),成(cheng)立古代(dai)(dai)(dai)经(jing)(jing)典(dian)(dian)名(ming)(ming)方(fang)(fang)中(zhong)(zhong)(zhong)药(yao)复(fu)方(fang)(fang)制(zhi)(zhi)剂(ji)专家审评委员(yuan)会(hui),实(shi)施简化(hua)审批。

(三)促进中(zhong)药(yao)(yao)(yao)创新发展(zhan)。探(tan)索引入新工具、新方(fang)法、新技术、新标准用(yong)于中(zhong)药(yao)(yao)(yao)疗(liao)效评(ping)价。推(tui)动开(kai)展(zhan)多(duo)(duo)区域临床试(shi)验规范性研究能力与体系建(jian)设,促进中(zhong)药(yao)(yao)(yao)临床研究质量整体提升。发挥医(yi)疗(liao)机构中(zhong)药(yao)(yao)(yao)制(zhi)剂(ji)(ji)传承创新发展(zhan)“孵化(hua)(hua)器(qi)”作(zuo)用(yong),鼓励医(yi)疗(liao)机构制(zhi)剂(ji)(ji)向(xiang)中(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)转化(hua)(hua)。支(zhi)持以病证(zheng)结合、专病专药(yao)(yao)(yao)或证(zheng)候(hou)类(lei)中(zhong)药(yao)(yao)(yao)等多(duo)(duo)种(zhong)方(fang)式开(kai)展(zhan)中(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)研制(zhi)。

(四)鼓(gu)励二次开发。制定中药(yao)改(gai)良型新(xin)药(yao)研究(jiu)相(xiang)关(guan)技术要求,支持运用(yong)符合产品(pin)特点的新(xin)技术、新(xin)工艺(yi)以及体现临床(chuang)应用(yong)优势和特点的新(xin)剂型改(gai)进已上市中药(yao)品(pin)种(zhong)。支持同名同方药(yao)的研制,促进已上市中药(yao)同品(pin)种(zhong)的质(zhi)量竞(jing)争。优化已上市中药(yao)变(bian)更相(xiang)关(guan)技术要求。

(五(wu))加强中(zhong)药(yao)(yao)(yao)安全(quan)(quan)性(xing)(xing)研究。引(yin)导(dao)药(yao)(yao)(yao)品上市(shi)(shi)许(xu)可持有人主动开(kai)展中(zhong)药(yao)(yao)(yao)上市(shi)(shi)后(hou)研究和(he)(he)上市(shi)(shi)后(hou)评价(jia)。建立符合中(zhong)药(yao)(yao)(yao)特点的(de)(de)(de)安全(quan)(quan)性(xing)(xing)评价(jia)方法和(he)(he)标(biao)准体系(xi),建立以中(zhong)医临床为(wei)导(dao)向的(de)(de)(de)中(zhong)药(yao)(yao)(yao)安全(quan)(quan)性(xing)(xing)分类(lei)分级评价(jia)策略。加大对来源于(yu)古代经(jing)典名方、名老中(zhong)医验(yan)方、医疗机构制剂等(deng)具有人用(yong)经(jing)验(yan)的(de)(de)(de)中(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)安全(quan)(quan)性(xing)(xing)评价(jia)技(ji)术(shu)标(biao)准的(de)(de)(de)研究。根据(ju)药(yao)(yao)(yao)物(wu)组(zu)方、人用(yong)经(jing)验(yan)、制备工艺、用(yong)法用(yong)量、功(gong)能主治特点等(deng),在临床试验(yan)期间或(huo)上市(shi)(shi)后(hou),开(kai)展各(ge)阶段相应的(de)(de)(de)非临床和(he)(he)临床安全(quan)(quan)性(xing)(xing)研究。

三、健全符合中药特点的审(shen)评(ping)审(shen)批体系

(六)改革中(zhong)药注册(ce)分(fen)类。尊重中(zhong)医药特点,遵循(xun)中(zhong)药研制规律,将“安全(quan)、有(you)效、质(zhi)量可(ke)控”的(de)药品基(ji)本要求与中(zhong)医药传(chuan)承创新(xin)发(fa)展(zhan)独特的(de)理论体系和实践特点有(you)机结(jie)合(he)。根据中(zhong)药注册(ce)产品特性、创新(xin)程度和研制实践情况,改革中(zhong)药注册(ce)分(fen)类,不再(zai)仅以物质(zhi)基(ji)础作为划分(fen)注册(ce)类别的(de)依据,开辟具有(you)中(zhong)医药特色的(de)注册(ce)申报路径。

(七)构建“三结合”审评证据(ju)体系(xi)(xi)。进一步(bu)重视(shi)人(ren)用(yong)(yong)经验(yan)对(dui)(dui)中药(yao)安全性、有(you)效性的支持作(zuo)用(yong)(yong),按照(zhao)中药(yao)特点(dian)、研发(fa)规律(lv)和(he)实际,构建中医药(yao)理论、人(ren)用(yong)(yong)经验(yan)和(he)临床试验(yan)相(xiang)结合的审评证据(ju)体系(xi)(xi)。加强对(dui)(dui)人(ren)用(yong)(yong)经验(yan)的规范收集整理,规范申报资(zi)料要求。

(八)改(gai)革完(wan)善中(zhong)(zhong)(zhong)药审评(ping)审批(pi)制度。对(dui)(dui)临(lin)床(chuang)定(ding)位清晰且(qie)具有明显(xian)临(lin)床(chuang)价(jia)值,用(yong)于(yu)重大(da)疾(ji)病、罕(han)见(jian)病防治(zhi)(zhi)、临(lin)床(chuang)急需(xu)而市(shi)场(chang)短缺、或属于(yu)儿童用(yong)药的(de)中(zhong)(zhong)(zhong)药新(xin)药申请(qing)实(shi)行优先(xian)审评(ping)审批(pi)。对(dui)(dui)治(zhi)(zhi)疗(liao)严重危及(ji)(ji)生(sheng)命且(qie)尚无有效(xiao)治(zhi)(zhi)疗(liao)手段的(de)疾(ji)病以及(ji)(ji)国务院(yuan)卫生(sheng)健康或中(zhong)(zhong)(zhong)医药主管部门认定(ding)为急需(xu)的(de)中(zhong)(zhong)(zhong)药,药物临(lin)床(chuang)试验已有数据或高质量中(zhong)(zhong)(zhong)药人用(yong)经(jing)验证据显(xian)示疗(liao)效(xiao)并(bing)能(neng)预测其临(lin)床(chuang)价(jia)值的(de),可以附条件(jian)批(pi)准。对(dui)(dui)突发重大(da)公(gong)共(gong)卫生(sheng)事件(jian)中(zhong)(zhong)(zhong)应(ying)急所需(xu)的(de)已上市(shi)中(zhong)(zhong)(zhong)药增(zeng)加功能(neng)主治(zhi)(zhi)实(shi)施特别审批(pi)。

四(si)、强化中药质(zhi)量安全监(jian)管

(九)加(jia)强中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)质(zhi)(zhi)量(liang)(liang)源头管(guan)理(li)(li)(li)。修订中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)生(sheng)产(chan)(chan)质(zhi)(zhi)量(liang)(liang)管(guan)理(li)(li)(li)规范(GAP),制定(ding)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)生(sheng)产(chan)(chan)质(zhi)(zhi)量(liang)(liang)管(guan)理(li)(li)(li)规范实施(shi)指南,引导促进中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)规范化种植养殖(zhi),推动(dong)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)产(chan)(chan)地加(jia)工(gong),鼓励中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)企业将质(zhi)(zhi)量(liang)(liang)保障体系向种植加(jia)工(gong)环(huan)节延伸(shen),从源头加(jia)强中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)质(zhi)(zhi)量(liang)(liang)控制。加(jia)强和(he)规范中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)用中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)的质(zhi)(zhi)量(liang)(liang)管(guan)理(li)(li)(li),明确质(zhi)(zhi)量(liang)(liang)控制研究相(xiang)关技术要求。保护野(ye)生(sheng)药(yao)(yao)(yao)(yao)材(cai)资源,严格限定(ding)使用濒危野(ye)生(sheng)动(dong)、植物药(yao)(yao)(yao)(yao)材(cai)。加(jia)强开展中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)(yao)资源评估,保障中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材(cai)来源稳定(ding)和(he)资源可持续利用。

(十)加(jia)强(qiang)生(sheng)产(chan)(chan)全(quan)过(guo)程的质量控制。加(jia)大飞行检查力(li)度(du),严格执行药(yao)品(pin)生(sheng)产(chan)(chan)质量管理(li)(li)规范(GMP)。在(zai)传承中(zhong)(zhong)(zhong)药(yao)饮片(pian)传统炮(pao)制方(fang)法和(he)经验基础上,修(xiu)订(ding)药(yao)品(pin)生(sheng)产(chan)(chan)质量管理(li)(li)规范中(zhong)(zhong)(zhong)药(yao)饮片(pian)附录。持续(xu)修(xiu)订(ding)完善包括(kuo)中(zhong)(zhong)(zhong)药(yao)材、中(zhong)(zhong)(zhong)药(yao)饮片(pian)、中(zhong)(zhong)(zhong)间产(chan)(chan)品(pin)和(he)制剂等在(zai)内的完整的内控质量标(biao)准体系,保(bao)持药(yao)品(pin)批间质量稳(wen)定可控。推动(dong)中(zhong)(zhong)(zhong)药(yao)制药(yao)技(ji)术升级,鼓(gu)励生(sheng)产(chan)(chan)企业逐步实现智能制造。

(十(shi)一)加(jia)(jia)强(qiang)上(shang)市后监(jian)(jian)管。组织中(zhong)药(yao)(yao)(yao)(yao)专项检查,持续(xu)加(jia)(jia)大中(zhong)成药(yao)(yao)(yao)(yao)和(he)中(zhong)药(yao)(yao)(yao)(yao)饮片(pian)抽检力(li)度,持续(xu)排查化解风(feng)险隐患,依法(fa)处(chu)置违法(fa)违规企业(ye)。聚(ju)焦掺杂使假(jia)、染色增重、非(fei)法(fa)添加(jia)(jia)、非(fei)法(fa)渠道购入中(zhong)药(yao)(yao)(yao)(yao)饮片(pian)等问题,开展中(zhong)药(yao)(yao)(yao)(yao)饮片(pian)质(zhi)量集中(zhong)整治,严厉(li)打击(ji)违法(fa)违规行为。推(tui)动地方政(zheng)府落(luo)实(shi)地方监(jian)(jian)管责任,加(jia)(jia)强(qiang)对(dui)(dui)中(zhong)药(yao)(yao)(yao)(yao)材交(jiao)易市场的(de)监(jian)(jian)管,严厉(li)打击(ji)无(wu)证销售(shou)中(zhong)药(yao)(yao)(yao)(yao)饮片(pian)行为,持续(xu)净化市场秩序(xu)。基于中(zhong)医药(yao)(yao)(yao)(yao)发展实(shi)际(ji),研究完善按照省级饮片(pian)炮制(zhi)(zhi)规范生产中(zhong)药(yao)(yao)(yao)(yao)饮片(pian)的(de)流通政(zheng)策。强(qiang)化中(zhong)药(yao)(yao)(yao)(yao)不良反应监(jian)(jian)测,对(dui)(dui)监(jian)(jian)测中(zhong)发现的(de)风(feng)险信号(hao)及时(shi)组织评(ping)估并采取风(feng)险控制(zhi)(zhi)措(cuo)施(shi)。加(jia)(jia)强(qiang)中(zhong)药(yao)(yao)(yao)(yao)说明(ming)书(shu)和(he)标签管理,推(tui)进对(dui)(dui)已上(shang)市中(zhong)药(yao)(yao)(yao)(yao)说明(ming)书(shu)中(zhong)【禁忌】【不良反应】【注意事项】等相关内容的(de)修改完善。

(十二(er))加大保(bao)护(hu)中(zhong)(zhong)(zhong)药(yao)(yao)品种力度。修订《中(zhong)(zhong)(zhong)药(yao)(yao)品种保(bao)护(hu)条例》,将中(zhong)(zhong)(zhong)药(yao)(yao)品种保(bao)护(hu)制(zhi)度与专(zhuan)利保(bao)护(hu)制(zhi)度有机衔接,并纳入(ru)中(zhong)(zhong)(zhong)药(yao)(yao)全(quan)生命(ming)周期(qi)注(zhu)册管理之中(zhong)(zhong)(zhong),发挥其对中(zhong)(zhong)(zhong)药(yao)(yao)创新(xin)药(yao)(yao)、中(zhong)(zhong)(zhong)药(yao)(yao)改(gai)良型新(xin)药(yao)(yao)以及古代经(jing)典名方中(zhong)(zhong)(zhong)药(yao)(yao)复方制(zhi)剂等中(zhong)(zhong)(zhong)药(yao)(yao)品种的保(bao)护(hu)作用(yong)。支持(chi)药(yao)(yao)品上市许可持(chi)有人或申(shen)请人按有关规定(ding)进行相关专(zhuan)利信息的登(deng)记(ji)、声明。

五、注重(zhong)多方协调(diao)联动

(十三)加强横向联系。积极(ji)按照国务院中医药(yao)工作部际(ji)联席会议部署,加强与科技、卫生健(jian)康(kang)、中医药(yao)、医保等部门的沟通协调,形成(cheng)部门工作合(he)力,推(tui)进国家重大(da)科技项目的成(cheng)果转化(hua),满足临床需(xu)求,积极(ji)服务中药(yao)产业高质量发展。

(十四)督促(cu)落(luo)(luo)实各方责(ze)(ze)(ze)任(ren)。压(ya)实企(qi)(qi)业主体责(ze)(ze)(ze)任(ren),督促(cu)企(qi)(qi)业牢(lao)固树立质量安全第一责(ze)(ze)(ze)任(ren)人(ren)意识(shi),履行药(yao)品(pin)全生命周期管理责(ze)(ze)(ze)任(ren),推进中药(yao)企(qi)(qi)业诚信体系(xi)建设(she)。全面落(luo)(luo)实“四个(ge)最严”的(de)要(yao)求,切实承担起药(yao)品(pin)监管责(ze)(ze)(ze)任(ren),牢(lao)牢(lao)守(shou)住药(yao)品(pin)安全底线。推动地方党委政府扛(kang)起药(yao)品(pin)安全政治责(ze)(ze)(ze)任(ren),强(qiang)化(hua)属地管理责(ze)(ze)(ze)任(ren)。

(十五)营造良好社(she)会(hui)氛围(wei)。加大中药审(shen)评(ping)审(shen)批(pi)改革宣(xuan)传力(li)度,加强重要政策、重大措施解读(du),及时回应(ying)社(she)会(hui)关切(qie),合理引导各方预期,推(tui)动形成(cheng)全社(she)会(hui)共同参与中药传承(cheng)创新(xin)的(de)新(xin)格局。

六、推进(jin)中药监管体系和监管能力现代化

(十六)完(wan)善中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)法(fa)规(gui)标(biao)准体(ti)(ti)系。加(jia)快《药(yao)(yao)(yao)品管理法(fa)》《中(zhong)(zhong)(zhong)(zhong)医(yi)(yi)药(yao)(yao)(yao)法(fa)》相关配套规(gui)章制度建(jian)设,健全完(wan)善中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)全生命(ming)周(zhou)期监管制度体(ti)(ti)系。加(jia)强中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)标(biao)准管理,优(you)化(hua)国(guo)家药(yao)(yao)(yao)品标(biao)准形(xing)成机制,持续完(wan)善以《中(zhong)(zhong)(zhong)(zhong)国(guo)药(yao)(yao)(yao)典》为(wei)核(he)心的(de)国(guo)家药(yao)(yao)(yao)品标(biao)准体(ti)(ti)系。建(jian)立(li)和(he)完(wan)善以临(lin)床为(wei)导向、符合中(zhong)(zhong)(zhong)(zhong)医(yi)(yi)药(yao)(yao)(yao)特点(dian)的(de)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)质量(liang)标(biao)准、技术规(gui)范和(he)评价体(ti)(ti)系,全面客(ke)观反映中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)质量(liang)。研究完(wan)善中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材中(zhong)(zhong)(zhong)(zhong)农药(yao)(yao)(yao)残留(liu)、重金属与有害元素、真菌毒素等有害物(wu)质限(xian)量(liang)要(yao)求和(he)检测方(fang)法(fa)。制定实施(shi)(shi)全国(guo)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮(yin)(yin)片(pian)炮制规(gui)范。加(jia)强地方(fang)药(yao)(yao)(yao)材标(biao)准和(he)省级饮(yin)(yin)片(pian)炮制规(gui)范的(de)监督实施(shi)(shi)。

(十七)强化(hua)技术支撑体(ti)系建(jian)(jian)设(she)。以(yi)编(bian)制(zhi)“十四五”药(yao)(yao)(yao)品(pin)安全(quan)及高质量(liang)发展(zhan)规划为契(qi)机,开展(zhan)重(zhong)点课题研究,加强检(jian)验检(jian)测、审(shen)评审(shen)批、审(shen)核查验、监测评价等(deng)重(zhong)点技术支撑机构建(jian)(jian)设(she)。加强“智(zhi)慧(hui)监管(guan)”建(jian)(jian)设(she),创新利用大数(shu)据、互联网(wang)、云计算(suan)等(deng)现(xian)代信息技术,推进药(yao)(yao)(yao)品(pin)追溯(su)信息互通互享。推动(dong)相关部门共同开展(zhan)中药(yao)(yao)(yao)材信息化(hua)追溯(su)体(ti)系建(jian)(jian)设(she),进一步提(ti)高中药(yao)(yao)(yao)材质量(liang)安全(quan)保障(zhang)水(shui)平。稳步推进中药(yao)(yao)(yao)生(sheng)产企业建(jian)(jian)立药(yao)(yao)(yao)品(pin)追溯(su)体(ti)系,对中药(yao)(yao)(yao)产品(pin)赋(fu)码、扫码,逐步在(zai)药(yao)(yao)(yao)品(pin)生(sheng)产流(liu)通全(quan)过程(cheng)实现(xian)可(ke)追溯(su)。

(十八)加强中(zhong)(zhong)药(yao)监管(guan)科学(xue)(xue)研(yan)究(jiu)(jiu)(jiu)。鼓励运用(yong)现(xian)代科学(xue)(xue)技术和传统中(zhong)(zhong)医药(yao)研(yan)究(jiu)(jiu)(jiu)方法,深(shen)入开展(zhan)中(zhong)(zhong)药(yao)监管(guan)科学(xue)(xue)研(yan)究(jiu)(jiu)(jiu),积极(ji)推(tui)动中(zhong)(zhong)药(yao)监管(guan)理念、制(zhi)度、机(ji)制(zhi)创新(xin),强化(hua)(hua)成果转化(hua)(hua)应用(yong),推(tui)出一批中(zhong)(zhong)药(yao)监管(guan)新(xin)工具、新(xin)方法和新(xin)标准。深(shen)化(hua)(hua)与(yu)国(guo)内一流(liu)大学(xue)(xue)、科研(yan)机(ji)构之间(jian)合作(zuo),建立中(zhong)(zhong)药(yao)监管(guan)科学(xue)(xue)合作(zuo)研(yan)究(jiu)(jiu)(jiu)基(ji)(ji)地和国(guo)家药(yao)监局重(zhong)点实验室,强化(hua)(hua)中(zhong)(zhong)药(yao)监管(guan)基(ji)(ji)础性(xing)、战略性(xing)问题(ti)研(yan)究(jiu)(jiu)(jiu)。

(十九)加强(qiang)监(jian)管队(dui)伍建设。加快职(zhi)业(ye)(ye)化(hua)、专业(ye)(ye)化(hua)的中(zhong)药(yao)审评员(yuan)、检查员(yuan)队(dui)伍建设,完(wan)(wan)善(shan)分(fen)(fen)级分(fen)(fen)类管理制(zhi)度,明确岗位准入和任职(zhi)条(tiao)件。科学合理开展(zhan)(zhan)中(zhong)药(yao)专业(ye)(ye)人(ren)员(yuan)的考核评价和职(zhi)级升(sheng)降,扩宽职(zhi)业(ye)(ye)发展(zhan)(zhan)空间(jian),完(wan)(wan)善(shan)薪酬待遇保障机制(zhi),确保高层次人(ren)才“招得来、留(liu)得住”。  

(二十)积(ji)极推(tui)动国(guo)(guo)(guo)际(ji)传统(tong)药(yao)(yao)监(jian)管(guan)(guan)(guan)合(he)作(zuo)。深化(hua)与世(shi)界(jie)卫(wei)生组织(WHO)合(he)作(zuo),积(ji)极开展(zhan)与国(guo)(guo)(guo)际(ji)草(cao)药(yao)(yao)监(jian)管(guan)(guan)(guan)合(he)作(zuo)组织(IRCH)、西太区草(cao)药(yao)(yao)监(jian)管(guan)(guan)(guan)协调(diao)论坛(FHH)等(deng)传统(tong)药(yao)(yao)监(jian)管(guan)(guan)(guan)国(guo)(guo)(guo)际(ji)组织以及有关国(guo)(guo)(guo)家或(huo)地区药(yao)(yao)品监(jian)管(guan)(guan)(guan)、药(yao)(yao)典机构的(de)交流(liu),深入参与国(guo)(guo)(guo)际(ji)传统(tong)药(yao)(yao)相关政策(ce)规则制定、标准协调(diao),推(tui)动中(zhong)药(yao)(yao)标准国(guo)(guo)(guo)际(ji)化(hua)。持续提(ti)升我国(guo)(guo)(guo)中(zhong)药(yao)(yao)监(jian)管(guan)(guan)(guan)在(zai)国(guo)(guo)(guo)际(ji)监(jian)管(guan)(guan)(guan)组织中(zhong)的(de)话语权,推(tui)动中(zhong)医药(yao)(yao)更(geng)好地为全世(shi)界(jie)人民服(fu)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