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、自治区、直辖市药(yao)(yao)品监督管理局,新疆生产建设兵团药(yao)(yao)品监督管理局,局机关各司局,各直属(shu)单位:

中(zhong)(zhong)(zhong)药(yao)(yao)是(shi)中(zhong)(zhong)(zhong)华民族的(de)(de)(de)瑰宝,为(wei)造福人(ren)民健康作出巨大贡献,特(te)(te)别是(shi)新(xin)(xin)冠肺(fei)炎疫(yi)情(qing)(qing)爆发(fa)(fa)以来,中(zhong)(zhong)(zhong)药(yao)(yao)彰显特(te)(te)色优势(shi),为(wei)打赢疫(yi)情(qing)(qing)防(fang)控(kong)阻击战(zhan)发(fa)(fa)挥了(le)重(zhong)(zhong)要作用。党中(zhong)(zhong)(zhong)央国务院(yuan)高度重(zhong)(zhong)视中(zhong)(zhong)(zhong)医药(yao)(yao)工作,特(te)(te)别是(shi)党的(de)(de)(de)十八大以来,习近平总书记多次作出重(zhong)(zhong)要指示批示,要求改革完善中(zhong)(zhong)(zhong)药(yao)(yao)审(shen)评审(shen)批机制(zhi),为(wei)新(xin)(xin)时代中(zhong)(zhong)(zhong)药(yao)(yao)传承创新(xin)(xin)发(fa)(fa)展(zhan)指明了(le)方向、提供(gong)了(le)遵(zun)循。为(wei)进一(yi)步贯(guan)彻(che)习近平总书记系列重(zhong)(zhong)要指示批示精神(shen),深入落实中(zhong)(zhong)(zhong)共(gong)中(zhong)(zhong)(zhong)央、国务院(yuan)《关于促进中(zhong)(zhong)(zhong)医药(yao)(yao)传承创新(xin)(xin)发(fa)(fa)展(zhan)的(de)(de)(de)意见(jian)》决策部署,结合药(yao)(yao)品监管工作实际,提出以下意见(jian)。

一、指导思想(xiang)

以习近(jin)平新(xin)时(shi)代(dai)(dai)中(zhong)(zhong)国(guo)特(te)色(se)社会主义思(si)想为(wei)指导(dao),全(quan)面(mian)贯彻党的十(shi)九大和十(shi)九届二中(zhong)(zhong)、三中(zhong)(zhong)、四(si)中(zhong)(zhong)、五中(zhong)(zhong)全(quan)会精神,坚持以人民为(wei)中(zhong)(zhong)心的发展(zhan)(zhan)思(si)想,全(quan)面(mian)落(luo)实“四(si)个(ge)最严”的要求,促进中(zhong)(zhong)药(yao)(yao)传(chuan)承创(chuang)(chuang)新(xin)发展(zhan)(zhan)。深(shen)化改革,健全(quan)符合中(zhong)(zhong)药(yao)(yao)特(te)点的审(shen)评审(shen)批体系。传(chuan)承精华(hua),注重整体观和中(zhong)(zhong)医药(yao)(yao)原创(chuang)(chuang)思(si)维,促进中(zhong)(zhong)药(yao)(yao)守正(zheng)创(chuang)(chuang)新(xin)。坚守底线,强化中(zhong)(zhong)药(yao)(yao)质量安全(quan)监(jian)管。创(chuang)(chuang)新(xin)发展(zhan)(zhan),推进中(zhong)(zhong)药(yao)(yao)监(jian)管体系和监(jian)管能力现代(dai)(dai)化。

二(er)、促(cu)进中药守正创新

(一)坚(jian)持以(yi)(yi)临(lin)床(chuang)价值为导向。重视根据中(zhong)(zhong)医药(yao)(yao)(yao)临(lin)床(chuang)治疗(liao)特(te)点和(he)(he)实际(ji)评(ping)(ping)估临(lin)床(chuang)价值,注重满足尚未(wei)满足的临(lin)床(chuang)需求,制定(ding)中(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)临(lin)床(chuang)价值评(ping)(ping)估技(ji)术(shu)指导原则。建立与中(zhong)(zhong)药(yao)(yao)(yao)临(lin)床(chuang)定(ding)位相适应、体现其作用特(te)点和(he)(he)优势的疗(liao)效评(ping)(ping)价标(biao)准。鼓(gu)励开展以(yi)(yi)患者为中(zhong)(zhong)心的疗(liao)效评(ping)(ping)价。探索引入真(zhen)实世界证据用于(yu)支持中(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)注册上市。

(二)推(tui)动(dong)古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)中药(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)制(zhi)(zhi)(zhi)。明(ming)确(que)古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)中药(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)制(zhi)(zhi)(zhi)有(you)关技术要(yao)求,促进古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)中药(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)研(yan)发,推(tui)进古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)向新药(yao)(yao)转(zhuan)化。会同国务院中医药(yao)(yao)主管(guan)部门,建立沟通协调(diao)机制(zhi)(zhi)(zhi),组织研(yan)究、制(zhi)(zhi)(zhi)定古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)关键(jian)信息考(kao)证意(yi)见。建立与古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)中药(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)特点相(xiang)适应的审(shen)(shen)评模式(shi),成立古(gu)代(dai)(dai)经(jing)典(dian)名(ming)方(fang)(fang)(fang)(fang)中药(yao)(yao)复方(fang)(fang)(fang)(fang)制(zhi)(zhi)(zhi)剂(ji)专家审(shen)(shen)评委员会,实施简(jian)化审(shen)(shen)批(pi)。

(三)促(cu)进中(zhong)药(yao)(yao)(yao)(yao)创新发(fa)展(zhan)(zhan)。探索引入新工具、新方法(fa)、新技术、新标准(zhun)用于中(zhong)药(yao)(yao)(yao)(yao)疗(liao)效评(ping)价。推(tui)动(dong)开展(zhan)(zhan)多(duo)区域临床(chuang)试验规范(fan)性研(yan)究(jiu)能力与体系建设,促(cu)进中(zhong)药(yao)(yao)(yao)(yao)临床(chuang)研(yan)究(jiu)质量整体提升。发(fa)挥医疗(liao)机构(gou)中(zhong)药(yao)(yao)(yao)(yao)制剂(ji)传承创新发(fa)展(zhan)(zhan)“孵化器”作用,鼓励(li)医疗(liao)机构(gou)制剂(ji)向中(zhong)药(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)转(zhuan)化。支持(chi)以(yi)病(bing)(bing)证(zheng)(zheng)结合(he)、专病(bing)(bing)专药(yao)(yao)(yao)(yao)或证(zheng)(zheng)候类中(zhong)药(yao)(yao)(yao)(yao)等多(duo)种方式开展(zhan)(zhan)中(zhong)药(yao)(yao)(yao)(yao)新药(yao)(yao)(yao)(yao)研(yan)制。

(四(si))鼓励二次开发(fa)。制定中(zhong)药(yao)改(gai)良型新(xin)药(yao)研(yan)究相(xiang)关(guan)技(ji)(ji)术要(yao)求,支持(chi)(chi)运用(yong)符合产品(pin)特点的新(xin)技(ji)(ji)术、新(xin)工(gong)艺以及体现临床(chuang)应(ying)用(yong)优(you)(you)势和特点的新(xin)剂型改(gai)进已上(shang)市(shi)中(zhong)药(yao)品(pin)种(zhong)。支持(chi)(chi)同(tong)名同(tong)方药(yao)的研(yan)制,促进已上(shang)市(shi)中(zhong)药(yao)同(tong)品(pin)种(zhong)的质(zhi)量竞争。优(you)(you)化(hua)已上(shang)市(shi)中(zhong)药(yao)变(bian)更相(xiang)关(guan)技(ji)(ji)术要(yao)求。

(五)加(jia)强中(zhong)药(yao)安(an)全性研(yan)究。引导药(yao)品(pin)上市许可持有(you)人(ren)(ren)主(zhu)动开(kai)展(zhan)中(zhong)药(yao)上市后研(yan)究和上市后评(ping)价(jia)。建立符合中(zhong)药(yao)特点的安(an)全性评(ping)价(jia)方(fang)法(fa)和标(biao)准(zhun)体系,建立以中(zhong)医(yi)临床(chuang)(chuang)为导向的中(zhong)药(yao)安(an)全性分类分级评(ping)价(jia)策略。加(jia)大(da)对来源于古(gu)代(dai)经(jing)典名(ming)方(fang)、名(ming)老中(zhong)医(yi)验方(fang)、医(yi)疗(liao)机构制剂等具有(you)人(ren)(ren)用(yong)(yong)经(jing)验的中(zhong)药(yao)新药(yao)安(an)全性评(ping)价(jia)技术标(biao)准(zhun)的研(yan)究。根据药(yao)物组方(fang)、人(ren)(ren)用(yong)(yong)经(jing)验、制备工艺(yi)、用(yong)(yong)法(fa)用(yong)(yong)量、功能(neng)主(zhu)治特点等,在临床(chuang)(chuang)试验期(qi)间或(huo)上市后,开(kai)展(zhan)各阶段相应的非(fei)临床(chuang)(chuang)和临床(chuang)(chuang)安(an)全性研(yan)究。

三(san)、健全符合中药特(te)点的审评审批体系(xi)

(六)改(gai)革中(zhong)药注(zhu)册(ce)分类。尊重中(zhong)医(yi)药特点,遵循中(zhong)药研(yan)制(zhi)规律,将(jiang)“安全(quan)、有效、质(zhi)(zhi)量可控(kong)”的(de)药品基本(ben)要求与中(zhong)医(yi)药传(chuan)承创新(xin)发展(zhan)独(du)特的(de)理论体系和实践特点有机结(jie)合。根据(ju)中(zhong)药注(zhu)册(ce)产品特性、创新(xin)程度和研(yan)制(zhi)实践情况,改(gai)革中(zhong)药注(zhu)册(ce)分类,不(bu)再(zai)仅(jin)以物质(zhi)(zhi)基础作(zuo)为划分注(zhu)册(ce)类别的(de)依据(ju),开辟(pi)具有中(zhong)医(yi)药特色的(de)注(zhu)册(ce)申报(bao)路径。

(七)构建“三结合”审(shen)评证据体系(xi)(xi)。进一步重视人(ren)用(yong)(yong)经验对中(zhong)药安全性(xing)、有效性(xing)的支持作(zuo)用(yong)(yong),按照中(zhong)药特(te)点、研发规(gui)律和实际(ji),构建中(zhong)医药理(li)论、人(ren)用(yong)(yong)经验和临床试(shi)验相结合的审(shen)评证据体系(xi)(xi)。加强对人(ren)用(yong)(yong)经验的规(gui)范(fan)收集整理(li),规(gui)范(fan)申(shen)报资料要求。

(八)改(gai)革(ge)完善中(zhong)(zhong)药(yao)审(shen)评审(shen)批(pi)制度。对临床(chuang)(chuang)定(ding)位清晰且(qie)具有(you)明显(xian)临床(chuang)(chuang)价(jia)(jia)值,用(yong)于重(zhong)大疾病、罕见病防治(zhi)、临床(chuang)(chuang)急(ji)需而市(shi)(shi)场短缺、或属于儿童用(yong)药(yao)的(de)(de)(de)中(zhong)(zhong)药(yao)新药(yao)申请(qing)实行优先审(shen)评审(shen)批(pi)。对治(zhi)疗严重(zhong)危及生(sheng)命(ming)且(qie)尚无有(you)效治(zhi)疗手段(duan)的(de)(de)(de)疾病以(yi)及国务院卫生(sheng)健(jian)康或中(zhong)(zhong)医(yi)药(yao)主管部(bu)门认定(ding)为急(ji)需的(de)(de)(de)中(zhong)(zhong)药(yao),药(yao)物临床(chuang)(chuang)试验已(yi)有(you)数据(ju)或高(gao)质量中(zhong)(zhong)药(yao)人用(yong)经验证据(ju)显(xian)示疗效并能预(yu)测其临床(chuang)(chuang)价(jia)(jia)值的(de)(de)(de),可以(yi)附条件批(pi)准(zhun)。对突发(fa)重(zhong)大公共卫生(sheng)事件中(zhong)(zhong)应急(ji)所需的(de)(de)(de)已(yi)上市(shi)(shi)中(zhong)(zhong)药(yao)增加功能主治(zhi)实施特别审(shen)批(pi)。

四、强(qiang)化(hua)中药(yao)质(zhi)量安全监管

(九)加(jia)(jia)(jia)强中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)质(zhi)(zhi)量(liang)(liang)(liang)源(yuan)头管(guan)(guan)理(li)。修订中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)生(sheng)产(chan)质(zhi)(zhi)量(liang)(liang)(liang)管(guan)(guan)理(li)规(gui)范(fan)(GAP),制(zhi)(zhi)定中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)生(sheng)产(chan)质(zhi)(zhi)量(liang)(liang)(liang)管(guan)(guan)理(li)规(gui)范(fan)实施指南,引导促进中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)规(gui)范(fan)化种(zhong)(zhong)植养殖,推动中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)产(chan)地加(jia)(jia)(jia)工(gong),鼓励(li)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)饮片(pian)企业将质(zhi)(zhi)量(liang)(liang)(liang)保(bao)障体系向种(zhong)(zhong)植加(jia)(jia)(jia)工(gong)环节延伸,从源(yuan)头加(jia)(jia)(jia)强中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)饮片(pian)质(zhi)(zhi)量(liang)(liang)(liang)控制(zhi)(zhi)。加(jia)(jia)(jia)强和规(gui)范(fan)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)用(yong)(yong)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)饮片(pian)的(de)质(zhi)(zhi)量(liang)(liang)(liang)管(guan)(guan)理(li),明确(que)质(zhi)(zhi)量(liang)(liang)(liang)控制(zhi)(zhi)研究相关(guan)技术要求。保(bao)护野(ye)生(sheng)药(yao)(yao)材(cai)(cai)(cai)资源(yuan),严(yan)格限定使用(yong)(yong)濒(bin)危野(ye)生(sheng)动、植物药(yao)(yao)材(cai)(cai)(cai)。加(jia)(jia)(jia)强开展中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)新(xin)药(yao)(yao)资源(yuan)评估,保(bao)障中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)材(cai)(cai)(cai)来源(yuan)稳定和资源(yuan)可持续利(li)用(yong)(yong)。

(十)加强生产全过(guo)程的(de)质(zhi)(zhi)量(liang)(liang)控(kong)(kong)(kong)制。加大飞行检查力度,严格执行药(yao)(yao)品生产质(zhi)(zhi)量(liang)(liang)管(guan)理(li)规范(GMP)。在传承中(zhong)(zhong)药(yao)(yao)饮片(pian)传统炮制方法(fa)和经验基础上,修(xiu)订药(yao)(yao)品生产质(zhi)(zhi)量(liang)(liang)管(guan)理(li)规范中(zhong)(zhong)药(yao)(yao)饮片(pian)附录。持(chi)续修(xiu)订完善(shan)包括(kuo)中(zhong)(zhong)药(yao)(yao)材、中(zhong)(zhong)药(yao)(yao)饮片(pian)、中(zhong)(zhong)间产品和制剂等在内的(de)完整的(de)内控(kong)(kong)(kong)质(zhi)(zhi)量(liang)(liang)标准体系,保持(chi)药(yao)(yao)品批间质(zhi)(zhi)量(liang)(liang)稳(wen)定(ding)可控(kong)(kong)(kong)。推动中(zhong)(zhong)药(yao)(yao)制药(yao)(yao)技术升级,鼓励(li)生产企业(ye)逐步(bu)实现智能(neng)制造。

(十(shi)一)加(jia)强(qiang)上市(shi)(shi)(shi)后监(jian)管(guan)。组织中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)专项检(jian)查(cha),持续加(jia)大中(zhong)(zhong)(zhong)(zhong)成药(yao)(yao)(yao)(yao)(yao)(yao)和(he)(he)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)饮片抽(chou)检(jian)力度,持续排(pai)查(cha)化(hua)解风(feng)险隐(yin)患,依法(fa)处置(zhi)违法(fa)违规企业。聚焦(jiao)掺杂使假(jia)、染色(se)增重、非法(fa)添加(jia)、非法(fa)渠道购入(ru)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)饮片等问题,开展(zhan)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)饮片质量集中(zhong)(zhong)(zhong)(zhong)整治,严厉(li)打(da)击(ji)违法(fa)违规行为。推动地方(fang)(fang)政府(fu)落实地方(fang)(fang)监(jian)管(guan)责任,加(jia)强(qiang)对(dui)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)材交易市(shi)(shi)(shi)场(chang)的(de)监(jian)管(guan),严厉(li)打(da)击(ji)无证(zheng)销(xiao)售中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)饮片行为,持续净(jing)化(hua)市(shi)(shi)(shi)场(chang)秩序。基于中(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)(yao)(yao)(yao)(yao)发展(zhan)实际,研究完善(shan)按照省(sheng)级饮片炮制(zhi)(zhi)规范(fan)生产中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)饮片的(de)流通(tong)政策。强(qiang)化(hua)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)不良(liang)反应(ying)监(jian)测,对(dui)监(jian)测中(zhong)(zhong)(zhong)(zhong)发现(xian)的(de)风(feng)险信号及时组织评估并采取风(feng)险控制(zhi)(zhi)措(cuo)施。加(jia)强(qiang)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)说(shuo)明(ming)书(shu)和(he)(he)标签(qian)管(guan)理,推进对(dui)已(yi)上市(shi)(shi)(shi)中(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)(yao)(yao)(yao)说(shuo)明(ming)书(shu)中(zhong)(zhong)(zhong)(zhong)【禁忌】【不良(liang)反应(ying)】【注意事项】等相关内容的(de)修改完善(shan)。

(十二)加(jia)大保护(hu)中(zhong)药(yao)品种(zhong)力度(du)。修订《中(zhong)药(yao)品种(zhong)保护(hu)条例》,将中(zhong)药(yao)品种(zhong)保护(hu)制度(du)与专利保护(hu)制度(du)有(you)机(ji)衔接,并纳入中(zhong)药(yao)全生命周期(qi)注册管(guan)理之中(zhong),发挥其对(dui)中(zhong)药(yao)创新药(yao)、中(zhong)药(yao)改良(liang)型新药(yao)以(yi)及古代经典名方中(zhong)药(yao)复方制剂等中(zhong)药(yao)品种(zhong)的保护(hu)作(zuo)用。支(zhi)持药(yao)品上(shang)市(shi)许可持有(you)人(ren)或申请人(ren)按有(you)关规(gui)定(ding)进行相关专利信息的登记、声明(ming)。

五、注重(zhong)多(duo)方(fang)协调联动

(十三)加强横向(xiang)联系。积极(ji)按照(zhao)国务院(yuan)中(zhong)医药工(gong)作(zuo)部(bu)际联席会议部(bu)署,加强与科(ke)技、卫(wei)生健康、中(zhong)医药、医保(bao)等部(bu)门的(de)沟(gou)通协调,形成部(bu)门工(gong)作(zuo)合力,推进国家(jia)重大科(ke)技项目的(de)成果转化,满足临床需求(qiu),积极(ji)服务中(zhong)药产业高质量发(fa)展(zhan)。

(十(shi)四(si)(si))督促落实(shi)各(ge)方(fang)责(ze)任(ren)。压实(shi)企业主体(ti)责(ze)任(ren),督促企业牢固树立(li)质量(liang)安全(quan)(quan)(quan)(quan)第一责(ze)任(ren)人意识,履行药品(pin)全(quan)(quan)(quan)(quan)生(sheng)命周期管理(li)责(ze)任(ren),推(tui)进中药企业诚信(xin)体(ti)系建设。全(quan)(quan)(quan)(quan)面落实(shi)“四(si)(si)个最严”的要求,切实(shi)承担起(qi)药品(pin)监管责(ze)任(ren),牢牢守住药品(pin)安全(quan)(quan)(quan)(quan)底线。推(tui)动(dong)地(di)方(fang)党委政(zheng)府(fu)扛起(qi)药品(pin)安全(quan)(quan)(quan)(quan)政(zheng)治责(ze)任(ren),强化(hua)属地(di)管理(li)责(ze)任(ren)。

(十五)营造良好社(she)会(hui)(hui)氛围。加大中(zhong)药审评(ping)审批(pi)改革宣传力度,加强(qiang)重(zhong)要政(zheng)策(ce)、重(zhong)大措(cuo)施解读,及时回应社(she)会(hui)(hui)关切,合(he)理引(yin)导各方(fang)预期,推动形成全社(she)会(hui)(hui)共同参与中(zhong)药传承创新的新格局。

六(liu)、推进(jin)中药(yao)监(jian)管体(ti)系和监(jian)管能力现代化

(十六)完善(shan)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)法规标(biao)(biao)(biao)准(zhun)(zhun)体系。加快《药(yao)(yao)(yao)品管理法》《中(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)法》相关配套规章制度(du)建设,健全完善(shan)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)全生命周(zhou)期监管制度(du)体系。加强中(zhong)(zhong)(zhong)药(yao)(yao)(yao)标(biao)(biao)(biao)准(zhun)(zhun)管理,优化国(guo)家(jia)药(yao)(yao)(yao)品标(biao)(biao)(biao)准(zhun)(zhun)形成机制,持(chi)续完善(shan)以(yi)《中(zhong)(zhong)(zhong)国(guo)药(yao)(yao)(yao)典》为核心的国(guo)家(jia)药(yao)(yao)(yao)品标(biao)(biao)(biao)准(zhun)(zhun)体系。建立和(he)完善(shan)以(yi)临床为导(dao)向(xiang)、符合中(zhong)(zhong)(zhong)医(yi)药(yao)(yao)(yao)特点的中(zhong)(zhong)(zhong)药(yao)(yao)(yao)质量标(biao)(biao)(biao)准(zhun)(zhun)、技术规范和(he)评(ping)价体系,全面客(ke)观反映中(zhong)(zhong)(zhong)药(yao)(yao)(yao)质量。研究完善(shan)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)中(zhong)(zhong)(zhong)农药(yao)(yao)(yao)残留(liu)、重金属与有害元素、真(zhen)菌毒素等有害物质限量要求和(he)检测方法。制定实(shi)施全国(guo)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮片(pian)炮制规范。加强地方药(yao)(yao)(yao)材(cai)标(biao)(biao)(biao)准(zhun)(zhun)和(he)省级(ji)饮片(pian)炮制规范的监督实(shi)施。

(十(shi)七)强(qiang)(qiang)化技(ji)术(shu)(shu)支(zhi)撑体系(xi)建(jian)设(she)(she)。以编制“十(shi)四五(wu)”药(yao)品(pin)安全(quan)(quan)及高质(zhi)量发(fa)展规划(hua)为契机,开展重点课题研究,加强(qiang)(qiang)检验检测(ce)、审(shen)(shen)评审(shen)(shen)批、审(shen)(shen)核查验、监测(ce)评价等重点技(ji)术(shu)(shu)支(zhi)撑机构建(jian)设(she)(she)。加强(qiang)(qiang)“智慧监管”建(jian)设(she)(she),创(chuang)新利用(yong)大(da)数据、互(hu)联网(wang)、云计算等现(xian)代信息技(ji)术(shu)(shu),推进药(yao)品(pin)追溯信息互(hu)通(tong)互(hu)享。推动相(xiang)关部门共同(tong)开展中药(yao)材信息化追溯体系(xi)建(jian)设(she)(she),进一步提(ti)高中药(yao)材质(zhi)量安全(quan)(quan)保障水平。稳步推进中药(yao)生产(chan)企业建(jian)立药(yao)品(pin)追溯体系(xi),对中药(yao)产(chan)品(pin)赋码(ma)、扫码(ma),逐步在药(yao)品(pin)生产(chan)流通(tong)全(quan)(quan)过程实现(xian)可追溯。

(十(shi)八)加(jia)强(qiang)中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)科(ke)学研(yan)究(jiu)。鼓励(li)运用现代科(ke)学技术和(he)传统中(zhong)(zhong)医药(yao)(yao)(yao)(yao)研(yan)究(jiu)方法,深入开展中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)科(ke)学研(yan)究(jiu),积极推动(dong)中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)理念、制度、机制创新(xin),强(qiang)化成(cheng)果(guo)转化应用,推出一(yi)批(pi)中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)新(xin)工具、新(xin)方法和(he)新(xin)标准。深化与国内一(yi)流(liu)大学、科(ke)研(yan)机构之间合(he)作,建立中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)科(ke)学合(he)作研(yan)究(jiu)基地(di)和(he)国家(jia)药(yao)(yao)(yao)(yao)监局重(zhong)点实验室(shi),强(qiang)化中(zhong)(zhong)药(yao)(yao)(yao)(yao)监管(guan)(guan)基础性、战略性问题(ti)研(yan)究(jiu)。

(十九)加(jia)强监管队伍建(jian)设(she)。加(jia)快职业(ye)化(hua)、专业(ye)化(hua)的(de)中药审评(ping)员、检查(cha)员队伍建(jian)设(she),完善(shan)分(fen)级(ji)分(fen)类管理制度,明确岗位准(zhun)入(ru)和任职条件。科(ke)学合理开展中药专业(ye)人员的(de)考核评(ping)价和职级(ji)升降,扩宽职业(ye)发展空间,完善(shan)薪酬待遇保障机制,确保高层次人才“招(zhao)得来(lai)、留得住”。  

(二(er)十)积极推动国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)传(chuan)统药(yao)(yao)监(jian)管(guan)(guan)合(he)作。深化(hua)与(yu)世(shi)界(jie)卫(wei)生组(zu)织(zhi)(zhi)(WHO)合(he)作,积极开(kai)展(zhan)与(yu)国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)草药(yao)(yao)监(jian)管(guan)(guan)合(he)作组(zu)织(zhi)(zhi)(IRCH)、西太区草药(yao)(yao)监(jian)管(guan)(guan)协调(diao)论坛(FHH)等传(chuan)统药(yao)(yao)监(jian)管(guan)(guan)国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)组(zu)织(zhi)(zhi)以及有(you)关(guan)国(guo)(guo)(guo)(guo)(guo)家或(huo)地区药(yao)(yao)品(pin)监(jian)管(guan)(guan)、药(yao)(yao)典机构(gou)的(de)交流(liu),深入参与(yu)国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)传(chuan)统药(yao)(yao)相关(guan)政策规则制定、标准(zhun)协调(diao),推动中(zhong)药(yao)(yao)标准(zhun)国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)化(hua)。持(chi)续提升我国(guo)(guo)(guo)(guo)(guo)中(zhong)药(yao)(yao)监(jian)管(guan)(guan)在(zai)国(guo)(guo)(guo)(guo)(guo)际(ji)(ji)监(jian)管(guan)(guan)组(zu)织(zhi)(zhi)中(zhong)的(de)话语权(quan),推动中(zhong)医药(yao)(yao)更好地为全世(shi)界(jie)人民服务。

  

 

 


                                                                                 国家药监局                  

                                                                          2020年(nian)12月21日                

 

来源:国家药品监督管理局网站