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(qu)、直辖市药(yao)品监(jian)督(du)管理局(ju)(ju),新疆生产建设兵团药(yao)品监(jian)督(du)管理局(ju)(ju),局(ju)(ju)机关各(ge)司局(ju)(ju),各(ge)直属单位:

中(zhong)药是中(zhong)华民族的瑰宝,为(wei)造(zao)福(fu)人民健(jian)康作出巨(ju)大贡献,特别是新(xin)冠肺炎疫(yi)情爆发以来,中(zhong)药彰显(xian)特色优势,为(wei)打赢疫(yi)情防(fang)控阻击战发挥(hui)了(le)重(zhong)要(yao)作用。党(dang)中(zhong)央(yang)国(guo)务(wu)院高度重(zhong)视中(zhong)医药工(gong)作,特别是党(dang)的十八(ba)大以来,习(xi)近平总书(shu)记多次作出重(zhong)要(yao)指示批(pi)示,要(yao)求(qiu)改革完善(shan)中(zhong)药审评审批(pi)机制,为(wei)新(xin)时代中(zhong)药传承创(chuang)新(xin)发展指明了(le)方向、提(ti)供了(le)遵循(xun)。为(wei)进一步(bu)贯彻习(xi)近平总书(shu)记系列重(zhong)要(yao)指示批(pi)示精(jing)神,深入落实中(zhong)共中(zhong)央(yang)、国(guo)务(wu)院《关于促(cu)进中(zhong)医药传承创(chuang)新(xin)发展的意见》决策部署,结(jie)合药品监管工(gong)作实际,提(ti)出以下意见。

一、指导思想(xiang)

以习近平新时(shi)代中(zhong)国特色社会主(zhu)义思(si)想为指导,全面贯(guan)彻党的十九(jiu)大和(he)十九(jiu)届二中(zhong)、三中(zhong)、四(si)中(zhong)、五中(zhong)全会精神,坚持以人民为中(zhong)心(xin)的发展(zhan)(zhan)思(si)想,全面落(luo)实“四(si)个(ge)最严”的要求,促进中(zhong)药(yao)(yao)传(chuan)承(cheng)(cheng)创新发展(zhan)(zhan)。深化改革(ge),健全符合中(zhong)药(yao)(yao)特点的审评审批(pi)体系(xi)。传(chuan)承(cheng)(cheng)精华,注重整体观和(he)中(zhong)医(yi)药(yao)(yao)原创思(si)维,促进中(zhong)药(yao)(yao)守正创新。坚守底线,强化中(zhong)药(yao)(yao)质量(liang)安全监管(guan)(guan)。创新发展(zhan)(zhan),推进中(zhong)药(yao)(yao)监管(guan)(guan)体系(xi)和(he)监管(guan)(guan)能(neng)力现代化。

二(er)、促进中药守正创新

(一)坚持以临(lin)(lin)床(chuang)价值(zhi)为导向。重(zhong)视根(gen)据(ju)中(zhong)(zhong)医药(yao)(yao)临(lin)(lin)床(chuang)治疗特点和(he)实(shi)际评估临(lin)(lin)床(chuang)价值(zhi),注(zhu)重(zhong)满足(zu)尚未(wei)满足(zu)的临(lin)(lin)床(chuang)需(xu)求,制定(ding)(ding)中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)临(lin)(lin)床(chuang)价值(zhi)评估技术指导原则。建立与中(zhong)(zhong)药(yao)(yao)临(lin)(lin)床(chuang)定(ding)(ding)位相适应、体(ti)现其作用特点和(he)优势(shi)的疗效(xiao)评价标准。鼓励开展以患(huan)者为中(zhong)(zhong)心的疗效(xiao)评价。探(tan)索引入真实(shi)世界(jie)证据(ju)用于支(zhi)持中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)注(zhu)册(ce)上市。

(二)推动古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)中(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)。明确古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)中(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)有关(guan)技术要求,促进古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)中(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研发,推进古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)向(xiang)新药(yao)(yao)(yao)转化。会(hui)同(tong)国务院中(zhong)医药(yao)(yao)(yao)主管部门,建立沟通协调(diao)机制(zhi)(zhi)(zhi),组织研究、制(zhi)(zhi)(zhi)定古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)关(guan)键信息(xi)考证意见。建立与(yu)古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)中(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)特点相适应的审评模式,成立古代(dai)经(jing)(jing)(jing)典(dian)(dian)名方(fang)(fang)(fang)中(zhong)药(yao)(yao)(yao)复(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)专家审评委员会(hui),实施(shi)简(jian)化审批。

(三)促进(jin)中(zhong)(zhong)(zhong)药(yao)(yao)创新(xin)发(fa)展(zhan)。探索引入新(xin)工具、新(xin)方法、新(xin)技(ji)术、新(xin)标准用于中(zhong)(zhong)(zhong)药(yao)(yao)疗效评价。推(tui)动开(kai)(kai)展(zhan)多(duo)区域临(lin)床(chuang)试验规(gui)范性研究(jiu)能(neng)力与(yu)体系建设,促进(jin)中(zhong)(zhong)(zhong)药(yao)(yao)临(lin)床(chuang)研究(jiu)质量整(zheng)体提(ti)升。发(fa)挥医(yi)疗机(ji)构中(zhong)(zhong)(zhong)药(yao)(yao)制剂(ji)传承创新(xin)发(fa)展(zhan)“孵化(hua)器”作用,鼓励医(yi)疗机(ji)构制剂(ji)向中(zhong)(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)转化(hua)。支(zhi)持以病证结合、专病专药(yao)(yao)或证候(hou)类(lei)中(zhong)(zhong)(zhong)药(yao)(yao)等多(duo)种方式(shi)开(kai)(kai)展(zhan)中(zhong)(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)研制。

(四)鼓励二次开发。制定(ding)中(zhong)药(yao)改(gai)良型新药(yao)研究(jiu)相关技(ji)术(shu)要求,支(zhi)(zhi)持(chi)运用(yong)符合产品特点的(de)新技(ji)术(shu)、新工艺以及体(ti)现临床应(ying)用(yong)优势和特点的(de)新剂型改(gai)进(jin)已(yi)(yi)上(shang)市中(zhong)药(yao)品种。支(zhi)(zhi)持(chi)同(tong)(tong)名(ming)同(tong)(tong)方药(yao)的(de)研制,促进(jin)已(yi)(yi)上(shang)市中(zhong)药(yao)同(tong)(tong)品种的(de)质量(liang)竞争。优化已(yi)(yi)上(shang)市中(zhong)药(yao)变更相关技(ji)术(shu)要求。

(五)加(jia)强(qiang)中药(yao)(yao)(yao)安全性(xing)(xing)(xing)(xing)(xing)研(yan)究(jiu)。引导(dao)药(yao)(yao)(yao)品上市许(xu)可(ke)持有人(ren)(ren)主动开展中药(yao)(yao)(yao)上市后研(yan)究(jiu)和(he)上市后评(ping)价(jia)。建立(li)符(fu)合(he)中药(yao)(yao)(yao)特(te)点的(de)安全性(xing)(xing)(xing)(xing)(xing)评(ping)价(jia)方法和(he)标准体系,建立(li)以(yi)中医临床为导(dao)向的(de)中药(yao)(yao)(yao)安全性(xing)(xing)(xing)(xing)(xing)分(fen)类分(fen)级评(ping)价(jia)策略。加(jia)大对来(lai)源于古代经(jing)典名(ming)(ming)方、名(ming)(ming)老中医验(yan)方、医疗(liao)机(ji)构制剂等具(ju)有人(ren)(ren)用(yong)(yong)经(jing)验(yan)的(de)中药(yao)(yao)(yao)新药(yao)(yao)(yao)安全性(xing)(xing)(xing)(xing)(xing)评(ping)价(jia)技术(shu)标准的(de)研(yan)究(jiu)。根据药(yao)(yao)(yao)物组方、人(ren)(ren)用(yong)(yong)经(jing)验(yan)、制备工(gong)艺、用(yong)(yong)法用(yong)(yong)量、功能(neng)主治特(te)点等,在(zai)临床试验(yan)期(qi)间或(huo)上市后,开展各阶段相应的(de)非临床和(he)临床安全性(xing)(xing)(xing)(xing)(xing)研(yan)究(jiu)。

三(san)、健(jian)全符合中药特点(dian)的审评审批体系

(六)改革中(zhong)药(yao)(yao)注册(ce)(ce)分类。尊重中(zhong)医药(yao)(yao)特(te)点,遵(zun)循中(zhong)药(yao)(yao)研制规律,将“安全、有效、质量可控”的(de)药(yao)(yao)品基本要求与中(zhong)医药(yao)(yao)传承创新发展(zhan)独特(te)的(de)理论(lun)体(ti)系和(he)实(shi)践特(te)点有机结合。根据(ju)中(zhong)药(yao)(yao)注册(ce)(ce)产品特(te)性、创新程度和(he)研制实(shi)践情况,改革中(zhong)药(yao)(yao)注册(ce)(ce)分类,不再(zai)仅以物质基础作为划分注册(ce)(ce)类别的(de)依据(ju),开辟具有中(zhong)医药(yao)(yao)特(te)色的(de)注册(ce)(ce)申报路径。

(七)构建“三结(jie)合(he)(he)”审评(ping)证据体(ti)系(xi)。进(jin)一(yi)步重视人用经验(yan)(yan)对中药安全性(xing)、有效(xiao)性(xing)的(de)支持作用,按(an)照中药特点、研发规(gui)律和(he)实际(ji),构建中医(yi)药理论、人用经验(yan)(yan)和(he)临床(chuang)试(shi)验(yan)(yan)相结(jie)合(he)(he)的(de)审评(ping)证据体(ti)系(xi)。加强对人用经验(yan)(yan)的(de)规(gui)范收集(ji)整(zheng)理,规(gui)范申报资料要求。

(八)改革(ge)完善中(zhong)(zhong)药(yao)(yao)审(shen)(shen)评审(shen)(shen)批(pi)(pi)制(zhi)度。对临(lin)床定位清晰且(qie)具有(you)明(ming)显(xian)临(lin)床价值(zhi),用(yong)于重大疾病(bing)、罕见病(bing)防(fang)治(zhi)、临(lin)床急(ji)需而(er)市场(chang)短缺、或(huo)属(shu)于儿(er)童(tong)用(yong)药(yao)(yao)的(de)中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)申请实行(xing)优先审(shen)(shen)评审(shen)(shen)批(pi)(pi)。对治(zhi)疗(liao)严重危及生命(ming)且(qie)尚无有(you)效(xiao)治(zhi)疗(liao)手段(duan)的(de)疾病(bing)以及国务院卫生健康或(huo)中(zhong)(zhong)医药(yao)(yao)主管部门认定为(wei)急(ji)需的(de)中(zhong)(zhong)药(yao)(yao),药(yao)(yao)物临(lin)床试验已有(you)数据或(huo)高质量(liang)中(zhong)(zhong)药(yao)(yao)人用(yong)经验证据显(xian)示疗(liao)效(xiao)并能预测(ce)其临(lin)床价值(zhi)的(de),可以附条件(jian)批(pi)(pi)准。对突(tu)发重大公共卫生事件(jian)中(zhong)(zhong)应急(ji)所需的(de)已上市中(zhong)(zhong)药(yao)(yao)增加功能主治(zhi)实施特别审(shen)(shen)批(pi)(pi)。

四、强化中药质量安全监管

(九)加(jia)(jia)(jia)强(qiang)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)质(zhi)(zhi)(zhi)(zhi)量(liang)源头管理。修订中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)生(sheng)(sheng)产(chan)(chan)质(zhi)(zhi)(zhi)(zhi)量(liang)管理规(gui)范(GAP),制定(ding)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)生(sheng)(sheng)产(chan)(chan)质(zhi)(zhi)(zhi)(zhi)量(liang)管理规(gui)范实施指南,引导促进中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)规(gui)范化种(zhong)植养殖(zhi),推动中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)产(chan)(chan)地加(jia)(jia)(jia)工,鼓励中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)饮片(pian)企业将质(zhi)(zhi)(zhi)(zhi)量(liang)保障体(ti)系向种(zhong)植加(jia)(jia)(jia)工环节延伸,从源头加(jia)(jia)(jia)强(qiang)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)饮片(pian)质(zhi)(zhi)(zhi)(zhi)量(liang)控制。加(jia)(jia)(jia)强(qiang)和规(gui)范中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)(yao)用(yong)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)饮片(pian)的质(zhi)(zhi)(zhi)(zhi)量(liang)管理,明(ming)确质(zhi)(zhi)(zhi)(zhi)量(liang)控制研(yan)究相关技术要求。保护野(ye)生(sheng)(sheng)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)资(zi)源,严(yan)格限定(ding)使(shi)用(yong)濒危野(ye)生(sheng)(sheng)动、植物药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)。加(jia)(jia)(jia)强(qiang)开(kai)展(zhan)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)(yao)资(zi)源评估(gu),保障中(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)材(cai)(cai)来源稳定(ding)和资(zi)源可(ke)持(chi)续利用(yong)。

(十)加强(qiang)生产(chan)全(quan)过程的(de)质(zhi)(zhi)量(liang)(liang)控制(zhi)。加大飞行(xing)检查力度,严格(ge)执行(xing)药品(pin)(pin)生产(chan)质(zhi)(zhi)量(liang)(liang)管(guan)理规范(GMP)。在(zai)传承中(zhong)药饮(yin)片传统炮制(zhi)方法和经(jing)验(yan)基础上,修订药品(pin)(pin)生产(chan)质(zhi)(zhi)量(liang)(liang)管(guan)理规范中(zhong)药饮(yin)片附(fu)录。持(chi)续修订完善包(bao)括中(zhong)药材、中(zhong)药饮(yin)片、中(zhong)间产(chan)品(pin)(pin)和制(zhi)剂(ji)等在(zai)内(nei)的(de)完整的(de)内(nei)控质(zhi)(zhi)量(liang)(liang)标准体(ti)系,保持(chi)药品(pin)(pin)批间质(zhi)(zhi)量(liang)(liang)稳定可(ke)控。推动中(zhong)药制(zhi)药技(ji)术(shu)升级(ji),鼓励生产(chan)企业逐(zhu)步实(shi)现智能制(zhi)造。

(十一)加(jia)强(qiang)上市(shi)(shi)后监(jian)(jian)管(guan)。组织中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)专项检(jian)查(cha),持(chi)(chi)续加(jia)大中(zhong)(zhong)(zhong)(zhong)成药(yao)(yao)(yao)(yao)和中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)抽检(jian)力度(du),持(chi)(chi)续排查(cha)化解风险隐患,依(yi)法(fa)(fa)处置违(wei)(wei)法(fa)(fa)违(wei)(wei)规企(qi)业。聚焦掺(chan)杂使假(jia)、染色增(zeng)重、非法(fa)(fa)添加(jia)、非法(fa)(fa)渠道购入中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)等(deng)问题(ti),开展(zhan)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)质量集中(zhong)(zhong)(zhong)(zhong)整治(zhi),严厉打击违(wei)(wei)法(fa)(fa)违(wei)(wei)规行为。推(tui)动地方政府落实(shi)地方监(jian)(jian)管(guan)责任,加(jia)强(qiang)对中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)材交易市(shi)(shi)场(chang)的监(jian)(jian)管(guan),严厉打击无证销(xiao)售中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)行为,持(chi)(chi)续净化市(shi)(shi)场(chang)秩(zhi)序。基于中(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)发展(zhan)实(shi)际,研究完善(shan)按照省(sheng)级饮片(pian)炮制(zhi)规范生产中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)饮片(pian)的流(liu)通(tong)政策。强(qiang)化中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)不良反(fan)应监(jian)(jian)测(ce),对监(jian)(jian)测(ce)中(zhong)(zhong)(zhong)(zhong)发现的风险信号及(ji)时组织评估(gu)并(bing)采(cai)取风险控制(zhi)措施。加(jia)强(qiang)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)说明书和标签管(guan)理(li),推(tui)进对已上市(shi)(shi)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)说明书中(zhong)(zhong)(zhong)(zhong)【禁(jin)忌】【不良反(fan)应】【注意(yi)事(shi)项】等(deng)相关内容(rong)的修改完善(shan)。

(十二)加(jia)大保(bao)(bao)护(hu)中(zhong)(zhong)药(yao)品(pin)种(zhong)力(li)度。修订《中(zhong)(zhong)药(yao)品(pin)种(zhong)保(bao)(bao)护(hu)条(tiao)例》,将(jiang)中(zhong)(zhong)药(yao)品(pin)种(zhong)保(bao)(bao)护(hu)制度与专利保(bao)(bao)护(hu)制度有(you)机衔接(jie),并(bing)纳入中(zhong)(zhong)药(yao)全生(sheng)命周期注册(ce)管理之中(zhong)(zhong),发(fa)挥其对中(zhong)(zhong)药(yao)创新药(yao)、中(zhong)(zhong)药(yao)改良型新药(yao)以及古代经典名方中(zhong)(zhong)药(yao)复方制剂等中(zhong)(zhong)药(yao)品(pin)种(zhong)的(de)保(bao)(bao)护(hu)作用。支持(chi)药(yao)品(pin)上市许可持(chi)有(you)人或申请人按有(you)关(guan)(guan)规定进行相关(guan)(guan)专利信息的(de)登记、声明。

五、注重多方协调联动(dong)

(十三(san))加(jia)强(qiang)横(heng)向联系。积极(ji)按(an)照国务院中(zhong)(zhong)医药工(gong)作(zuo)部(bu)际联席(xi)会议部(bu)署,加(jia)强(qiang)与科技、卫生健康、中(zhong)(zhong)医药、医保(bao)等部(bu)门的沟通协调,形成部(bu)门工(gong)作(zuo)合(he)力,推进国家重大科技项目的成果转(zhuan)化,满足临床需求,积极(ji)服务中(zhong)(zhong)药产(chan)业(ye)高质量发展。

(十四)督促落实各(ge)方责任(ren)(ren)。压实企业(ye)主体责任(ren)(ren),督促企业(ye)牢固(gu)树立质(zhi)量安全(quan)第(di)一责任(ren)(ren)人意识,履行药品全(quan)生命周期管(guan)理(li)责任(ren)(ren),推进中药企业(ye)诚信体系建(jian)设。全(quan)面落实“四个最严”的要求,切实承担(dan)起药品监管(guan)责任(ren)(ren),牢牢守住药品安全(quan)底(di)线。推动地方党委政府扛起药品安全(quan)政治(zhi)责任(ren)(ren),强(qiang)化属地管(guan)理(li)责任(ren)(ren)。

(十五)营造(zao)良好社(she)会(hui)氛围。加大中药审(shen)评审(shen)批改革宣传力度,加强重要政(zheng)策、重大措施解读,及时回应社(she)会(hui)关切,合理(li)引导(dao)各(ge)方预期,推动形成全社(she)会(hui)共同(tong)参与中药传承创新的新格局(ju)。

六、推进中(zhong)药监(jian)(jian)管体系和监(jian)(jian)管能力现代化

(十六)完(wan)善中(zhong)药(yao)(yao)法(fa)规标(biao)(biao)(biao)准(zhun)(zhun)(zhun)体(ti)系(xi)(xi)。加(jia)快(kuai)《药(yao)(yao)品(pin)管(guan)(guan)理法(fa)》《中(zhong)医药(yao)(yao)法(fa)》相(xiang)关配套规章制(zhi)(zhi)(zhi)度建设,健全(quan)完(wan)善中(zhong)药(yao)(yao)全(quan)生命周期监管(guan)(guan)制(zhi)(zhi)(zhi)度体(ti)系(xi)(xi)。加(jia)强(qiang)中(zhong)药(yao)(yao)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)管(guan)(guan)理,优化(hua)国(guo)家(jia)药(yao)(yao)品(pin)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)形成机制(zhi)(zhi)(zhi),持(chi)续完(wan)善以《中(zhong)国(guo)药(yao)(yao)典》为(wei)核(he)心的国(guo)家(jia)药(yao)(yao)品(pin)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)体(ti)系(xi)(xi)。建立和(he)完(wan)善以临床(chuang)为(wei)导向、符合中(zhong)医药(yao)(yao)特点的中(zhong)药(yao)(yao)质量标(biao)(biao)(biao)准(zhun)(zhun)(zhun)、技术(shu)规范(fan)和(he)评价体(ti)系(xi)(xi),全(quan)面客(ke)观反(fan)映(ying)中(zhong)药(yao)(yao)质量。研(yan)究(jiu)完(wan)善中(zhong)药(yao)(yao)材中(zhong)农药(yao)(yao)残留、重金属与有害元(yuan)素(su)、真菌(jun)毒素(su)等有害物质限量要求和(he)检测方(fang)(fang)法(fa)。制(zhi)(zhi)(zhi)定实施全(quan)国(guo)中(zhong)药(yao)(yao)饮片炮制(zhi)(zhi)(zhi)规范(fan)。加(jia)强(qiang)地方(fang)(fang)药(yao)(yao)材标(biao)(biao)(biao)准(zhun)(zhun)(zhun)和(he)省(sheng)级饮片炮制(zhi)(zhi)(zhi)规范(fan)的监督(du)实施。

(十七)强化技术(shu)支撑体(ti)系建设。以编制“十四(si)五”药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)安全(quan)及高质量(liang)发展(zhan)规(gui)划为契机(ji),开(kai)展(zhan)重点(dian)课题研究,加强检(jian)验(yan)检(jian)测、审评(ping)审批、审核查验(yan)、监测评(ping)价等(deng)重点(dian)技术(shu)支撑机(ji)构建设。加强“智慧监管”建设,创新利(li)用大数据(ju)、互联网、云(yun)计算等(deng)现(xian)代(dai)信(xin)息技术(shu),推进(jin)(jin)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)追溯(su)(su)信(xin)息互通(tong)互享。推动(dong)相关部门共同开(kai)展(zhan)中(zhong)药(yao)(yao)材信(xin)息化追溯(su)(su)体(ti)系建设,进(jin)(jin)一步(bu)(bu)提(ti)高中(zhong)药(yao)(yao)材质量(liang)安全(quan)保(bao)障水平。稳步(bu)(bu)推进(jin)(jin)中(zhong)药(yao)(yao)生(sheng)产(chan)企业建立药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)追溯(su)(su)体(ti)系,对中(zhong)药(yao)(yao)产(chan)品(pin)(pin)(pin)(pin)(pin)赋码、扫码,逐步(bu)(bu)在(zai)药(yao)(yao)品(pin)(pin)(pin)(pin)(pin)生(sheng)产(chan)流(liu)通(tong)全(quan)过程实现(xian)可(ke)追溯(su)(su)。

(十八)加(jia)强(qiang)中(zhong)(zhong)药(yao)监(jian)管科(ke)(ke)学(xue)研(yan)(yan)究(jiu)。鼓励(li)运用现(xian)代(dai)科(ke)(ke)学(xue)技术和传统(tong)中(zhong)(zhong)医药(yao)研(yan)(yan)究(jiu)方法,深入开展中(zhong)(zhong)药(yao)监(jian)管科(ke)(ke)学(xue)研(yan)(yan)究(jiu),积极(ji)推(tui)动中(zhong)(zhong)药(yao)监(jian)管理念、制度、机制创(chuang)新,强(qiang)化(hua)成果转化(hua)应(ying)用,推(tui)出一批中(zhong)(zhong)药(yao)监(jian)管新工具、新方法和新标准。深化(hua)与(yu)国内一流(liu)大学(xue)、科(ke)(ke)研(yan)(yan)机构之间(jian)合(he)作,建立中(zhong)(zhong)药(yao)监(jian)管科(ke)(ke)学(xue)合(he)作研(yan)(yan)究(jiu)基地和国家药(yao)监(jian)局重(zhong)点实验室,强(qiang)化(hua)中(zhong)(zhong)药(yao)监(jian)管基础性(xing)、战略性(xing)问题研(yan)(yan)究(jiu)。

(十九)加强监管(guan)队伍(wu)建设(she)。加快职(zhi)(zhi)业(ye)化、专业(ye)化的中(zhong)药审(shen)评员(yuan)、检查员(yuan)队伍(wu)建设(she),完(wan)善(shan)分(fen)级分(fen)类管(guan)理(li)制(zhi)度,明确岗(gang)位准入和任职(zhi)(zhi)条件(jian)。科(ke)学合理(li)开展(zhan)中(zhong)药专业(ye)人员(yuan)的考核评价和职(zhi)(zhi)级升降,扩宽职(zhi)(zhi)业(ye)发展(zhan)空间,完(wan)善(shan)薪(xin)酬待(dai)遇保(bao)障机(ji)制(zhi),确保(bao)高层次人才“招(zhao)得来、留得住(zhu)”。  

(二十)积极(ji)推动国(guo)际(ji)(ji)传统(tong)药监(jian)(jian)管(guan)合作。深化(hua)与(yu)(yu)世(shi)界(jie)卫(wei)生(sheng)组织(zhi)(WHO)合作,积极(ji)开展与(yu)(yu)国(guo)际(ji)(ji)草(cao)药监(jian)(jian)管(guan)合作组织(zhi)(IRCH)、西太(tai)区(qu)草(cao)药监(jian)(jian)管(guan)协(xie)(xie)调论坛(FHH)等传统(tong)药监(jian)(jian)管(guan)国(guo)际(ji)(ji)组织(zhi)以及有关国(guo)家或地区(qu)药品监(jian)(jian)管(guan)、药典(dian)机构的(de)交流,深入参与(yu)(yu)国(guo)际(ji)(ji)传统(tong)药相(xiang)关政策规则制(zhi)定、标准协(xie)(xie)调,推动中药标准国(guo)际(ji)(ji)化(hua)。持续(xu)提升(sheng)我国(guo)中药监(jian)(jian)管(guan)在国(guo)际(ji)(ji)监(jian)(jian)管(guan)组织(zhi)中的(de)话语权(quan),推动中医药更好地为全世(shi)界(jie)人民(min)服务。

  

 

 


                                                                                 国家药监局                  

                                                                          2020年12月21日(ri)                

 

来源:国家药品监督管理局网站