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(zi)治区、直(zhi)辖市(shi)药品监(jian)(jian)督管理局(ju)(ju),新疆生(sheng)产建设兵团药品监(jian)(jian)督管理局(ju)(ju),局(ju)(ju)机关各司局(ju)(ju),各直(zhi)属单位(wei):

中(zhong)(zhong)(zhong)(zhong)药(yao)是中(zhong)(zhong)(zhong)(zhong)华(hua)民(min)族(zu)的(de)瑰(gui)宝,为造福人民(min)健康作(zuo)出巨大贡献,特(te)别是新(xin)(xin)冠肺(fei)炎(yan)疫情爆(bao)发(fa)以来,中(zhong)(zhong)(zhong)(zhong)药(yao)彰显特(te)色优势(shi),为打赢疫情防控(kong)阻击战发(fa)挥了重(zhong)要(yao)(yao)作(zuo)用。党中(zhong)(zhong)(zhong)(zhong)央(yang)国务院高度重(zhong)视中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)工(gong)作(zuo),特(te)别是党的(de)十八大以来,习近平总(zong)(zong)书(shu)(shu)记(ji)多次作(zuo)出重(zhong)要(yao)(yao)指示(shi)批(pi)示(shi),要(yao)(yao)求(qiu)改革完善中(zhong)(zhong)(zhong)(zhong)药(yao)审评审批(pi)机制(zhi),为新(xin)(xin)时代中(zhong)(zhong)(zhong)(zhong)药(yao)传(chuan)承创(chuang)新(xin)(xin)发(fa)展(zhan)指明(ming)了方向、提供了遵(zun)循。为进(jin)(jin)一步贯彻习近平总(zong)(zong)书(shu)(shu)记(ji)系(xi)列重(zhong)要(yao)(yao)指示(shi)批(pi)示(shi)精神,深入落实中(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)央(yang)、国务院《关于促进(jin)(jin)中(zhong)(zhong)(zhong)(zhong)医(yi)药(yao)传(chuan)承创(chuang)新(xin)(xin)发(fa)展(zhan)的(de)意见》决策部署,结合药(yao)品监管工(gong)作(zuo)实际,提出以下意见。

一(yi)、指导思想(xiang)

以习(xi)近(jin)平(ping)新时代中(zhong)(zhong)(zhong)(zhong)(zhong)国(guo)特色社会(hui)主义(yi)思想(xiang)为(wei)(wei)指(zhi)导(dao),全面贯彻党的(de)十九(jiu)大(da)和(he)十九(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,坚持以人民为(wei)(wei)中(zhong)(zhong)(zhong)(zhong)(zhong)心的(de)发展(zhan)思想(xiang),全面落(luo)实“四个最严”的(de)要求(qiu),促进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)传承创新发展(zhan)。深化改革,健全符合中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)特点的(de)审(shen)(shen)评审(shen)(shen)批体系。传承精华,注(zhu)重(zhong)整(zheng)体观和(he)中(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)(yao)原创思维(wei),促进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)守正(zheng)创新。坚守底线,强化中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)质量(liang)安全监管。创新发展(zhan),推进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)监管体系和(he)监管能力现代化。

二、促进中(zhong)药守正创新

(一)坚持(chi)以临(lin)床(chuang)价值(zhi)为导向。重视根据(ju)中(zhong)(zhong)医药(yao)(yao)临(lin)床(chuang)治疗(liao)特点和实际(ji)评(ping)估(gu)(gu)临(lin)床(chuang)价值(zhi),注重满足(zu)尚未满足(zu)的(de)临(lin)床(chuang)需求,制定中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)临(lin)床(chuang)价值(zhi)评(ping)估(gu)(gu)技术指导原则。建立与中(zhong)(zhong)药(yao)(yao)临(lin)床(chuang)定位相适(shi)应、体现其作用(yong)特点和优势的(de)疗(liao)效评(ping)价标准。鼓励(li)开展以患者为中(zhong)(zhong)心的(de)疗(liao)效评(ping)价。探索(suo)引入真(zhen)实世界证据(ju)用(yong)于(yu)支持(chi)中(zhong)(zhong)药(yao)(yao)新药(yao)(yao)注册上市。

(二)推(tui)动(dong)古代(dai)经典名(ming)方中(zhong)药(yao)(yao)复方制(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)。明确古代(dai)经典名(ming)方中(zhong)药(yao)(yao)复方制(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)有关技术要求,促进(jin)古代(dai)经典名(ming)方中(zhong)药(yao)(yao)复方制(zhi)(zhi)(zhi)剂(ji)研发,推(tui)进(jin)古代(dai)经典名(ming)方向新药(yao)(yao)转化。会同国务院(yuan)中(zhong)医药(yao)(yao)主(zhu)管部门(men),建立(li)沟通协调机制(zhi)(zhi)(zhi),组织研究、制(zhi)(zhi)(zhi)定古代(dai)经典名(ming)方关键(jian)信息考证(zheng)意见。建立(li)与古代(dai)经典名(ming)方中(zhong)药(yao)(yao)复方制(zhi)(zhi)(zhi)剂(ji)特点相适应的审(shen)(shen)评(ping)模式,成立(li)古代(dai)经典名(ming)方中(zhong)药(yao)(yao)复方制(zhi)(zhi)(zhi)剂(ji)专家(jia)审(shen)(shen)评(ping)委员会,实施简化审(shen)(shen)批。

(三)促(cu)进中(zhong)药(yao)(yao)创新(xin)(xin)发(fa)展(zhan)。探索引入(ru)新(xin)(xin)工(gong)具、新(xin)(xin)方法(fa)、新(xin)(xin)技(ji)术、新(xin)(xin)标准用于中(zhong)药(yao)(yao)疗效(xiao)评(ping)价。推动开展(zhan)多(duo)(duo)区域临(lin)床试验规(gui)范性研(yan)究能力与体系(xi)建设,促(cu)进中(zhong)药(yao)(yao)临(lin)床研(yan)究质量整体提升。发(fa)挥医疗机构中(zhong)药(yao)(yao)制(zhi)剂传承创新(xin)(xin)发(fa)展(zhan)“孵化(hua)器”作用,鼓励医疗机构制(zhi)剂向(xiang)中(zhong)药(yao)(yao)新(xin)(xin)药(yao)(yao)转化(hua)。支持以病证结(jie)合、专病专药(yao)(yao)或(huo)证候类(lei)中(zhong)药(yao)(yao)等多(duo)(duo)种(zhong)方式(shi)开展(zhan)中(zhong)药(yao)(yao)新(xin)(xin)药(yao)(yao)研(yan)制(zhi)。

(四)鼓(gu)励二次开发(fa)。制定(ding)中(zhong)(zhong)药(yao)(yao)(yao)改良型新药(yao)(yao)(yao)研究相关技术要求(qiu),支(zhi)(zhi)持运(yun)用符合产品(pin)特(te)点的(de)新技术、新工艺(yi)以及体现临(lin)床应用优势和(he)特(te)点的(de)新剂型改进已(yi)(yi)上市中(zhong)(zhong)药(yao)(yao)(yao)品(pin)种(zhong)(zhong)。支(zhi)(zhi)持同(tong)(tong)名(ming)同(tong)(tong)方药(yao)(yao)(yao)的(de)研制,促(cu)进已(yi)(yi)上市中(zhong)(zhong)药(yao)(yao)(yao)同(tong)(tong)品(pin)种(zhong)(zhong)的(de)质量竞争。优化已(yi)(yi)上市中(zhong)(zhong)药(yao)(yao)(yao)变更相关技术要求(qiu)。

(五(wu))加强中(zhong)(zhong)药安全性(xing)(xing)研究(jiu)。引导(dao)药品上(shang)(shang)(shang)市(shi)许可持有(you)人(ren)主动开展(zhan)中(zhong)(zhong)药上(shang)(shang)(shang)市(shi)后(hou)研究(jiu)和上(shang)(shang)(shang)市(shi)后(hou)评(ping)价。建立符合(he)中(zhong)(zhong)药特点(dian)的(de)安全性(xing)(xing)评(ping)价方法(fa)和标准体系(xi),建立以(yi)中(zhong)(zhong)医临(lin)(lin)床(chuang)(chuang)为导(dao)向的(de)中(zhong)(zhong)药安全性(xing)(xing)分(fen)类分(fen)级评(ping)价策略(lve)。加大对来源于古(gu)代经(jing)典名方、名老中(zhong)(zhong)医验(yan)方、医疗机(ji)构制剂等(deng)具有(you)人(ren)用(yong)经(jing)验(yan)的(de)中(zhong)(zhong)药新(xin)药安全性(xing)(xing)评(ping)价技术标准的(de)研究(jiu)。根据药物组方、人(ren)用(yong)经(jing)验(yan)、制备(bei)工艺、用(yong)法(fa)用(yong)量、功(gong)能主治(zhi)特点(dian)等(deng),在临(lin)(lin)床(chuang)(chuang)试验(yan)期间或(huo)上(shang)(shang)(shang)市(shi)后(hou),开展(zhan)各阶段相应的(de)非临(lin)(lin)床(chuang)(chuang)和临(lin)(lin)床(chuang)(chuang)安全性(xing)(xing)研究(jiu)。

三、健全符(fu)合(he)中药(yao)特点的审评(ping)审批体(ti)系

(六)改革中(zhong)药(yao)(yao)注(zhu)(zhu)册分类。尊重(zhong)中(zhong)医(yi)药(yao)(yao)特(te)点,遵(zun)循中(zhong)药(yao)(yao)研(yan)制规律,将“安全、有效、质量可控(kong)”的(de)药(yao)(yao)品基本要求与中(zhong)医(yi)药(yao)(yao)传承(cheng)创新发展独特(te)的(de)理论体系和(he)实践特(te)点有机(ji)结合。根据(ju)中(zhong)药(yao)(yao)注(zhu)(zhu)册产品特(te)性、创新程度和(he)研(yan)制实践情况,改革中(zhong)药(yao)(yao)注(zhu)(zhu)册分类,不再(zai)仅以物(wu)质基础(chu)作(zuo)为划(hua)分注(zhu)(zhu)册类别的(de)依(yi)据(ju),开辟具(ju)有中(zhong)医(yi)药(yao)(yao)特(te)色的(de)注(zhu)(zhu)册申报(bao)路径。

(七)构建“三结合”审评(ping)证(zheng)据体系。进(jin)一步重视人(ren)用经(jing)验对中药安(an)全性(xing)、有效性(xing)的支持作用,按照中药特点、研发规律(lv)和实际,构建中医(yi)药理(li)论、人(ren)用经(jing)验和临床试验相结合的审评(ping)证(zheng)据体系。加强对人(ren)用经(jing)验的规范收(shou)集整理(li),规范申报资料(liao)要求。

(八(ba))改(gai)革完善中(zhong)药(yao)(yao)审(shen)(shen)(shen)(shen)评审(shen)(shen)(shen)(shen)批制度(du)。对临(lin)(lin)床(chuang)(chuang)定位清晰且具有(you)明显(xian)临(lin)(lin)床(chuang)(chuang)价值,用(yong)于重大疾(ji)病、罕见病防治(zhi)(zhi)、临(lin)(lin)床(chuang)(chuang)急需(xu)而(er)市(shi)场短缺、或属(shu)于儿童用(yong)药(yao)(yao)的(de)(de)(de)中(zhong)药(yao)(yao)新药(yao)(yao)申请(qing)实行优先审(shen)(shen)(shen)(shen)评审(shen)(shen)(shen)(shen)批。对治(zhi)(zhi)疗严重危及(ji)生命(ming)且尚无有(you)效治(zhi)(zhi)疗手(shou)段(duan)的(de)(de)(de)疾(ji)病以及(ji)国务院卫生健康(kang)或中(zhong)医药(yao)(yao)主管部(bu)门认(ren)定为(wei)急需(xu)的(de)(de)(de)中(zhong)药(yao)(yao),药(yao)(yao)物(wu)临(lin)(lin)床(chuang)(chuang)试验已有(you)数据或高质量(liang)中(zhong)药(yao)(yao)人用(yong)经验证据显(xian)示(shi)疗效并(bing)能预(yu)测(ce)其临(lin)(lin)床(chuang)(chuang)价值的(de)(de)(de),可以附条件(jian)批准(zhun)。对突发重大公共卫生事件(jian)中(zhong)应急所需(xu)的(de)(de)(de)已上(shang)市(shi)中(zhong)药(yao)(yao)增加功能主治(zhi)(zhi)实施特别审(shen)(shen)(shen)(shen)批。

四、强化中(zhong)药(yao)质量安全(quan)监管(guan)

(九)加(jia)(jia)强中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)质量(liang)(liang)(liang)(liang)源头管理(li)。修订中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)生(sheng)产质量(liang)(liang)(liang)(liang)管理(li)规范(GAP),制(zhi)定中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)生(sheng)产质量(liang)(liang)(liang)(liang)管理(li)规范实施指南,引导促(cu)进(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)规范化种植养殖,推动中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)产地加(jia)(jia)工(gong),鼓励中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮(yin)片(pian)(pian)企业将质量(liang)(liang)(liang)(liang)保(bao)障(zhang)体系向(xiang)种植加(jia)(jia)工(gong)环(huan)节(jie)延伸,从源头加(jia)(jia)强中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮(yin)片(pian)(pian)质量(liang)(liang)(liang)(liang)控制(zhi)。加(jia)(jia)强和(he)规范中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)用中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮(yin)片(pian)(pian)的质量(liang)(liang)(liang)(liang)管理(li),明确(que)质量(liang)(liang)(liang)(liang)控制(zhi)研究相关技术要(yao)求。保(bao)护野(ye)生(sheng)药(yao)(yao)(yao)材(cai)(cai)资源,严(yan)格(ge)限定使用濒危野(ye)生(sheng)动、植物药(yao)(yao)(yao)材(cai)(cai)。加(jia)(jia)强开展中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)新药(yao)(yao)(yao)资源评估(gu),保(bao)障(zhang)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)来源稳(wen)定和(he)资源可持续利用。

(十(shi))加(jia)强(qiang)生(sheng)产(chan)(chan)全(quan)过程的质(zhi)(zhi)量(liang)控(kong)制(zhi)。加(jia)大飞行检查力度,严格执行药(yao)(yao)品(pin)生(sheng)产(chan)(chan)质(zhi)(zhi)量(liang)管理规(gui)范(GMP)。在(zai)传承(cheng)中(zhong)药(yao)(yao)饮片传统炮(pao)制(zhi)方(fang)法(fa)和经验基础(chu)上,修(xiu)订药(yao)(yao)品(pin)生(sheng)产(chan)(chan)质(zhi)(zhi)量(liang)管理规(gui)范中(zhong)药(yao)(yao)饮片附录(lu)。持续修(xiu)订完善包括中(zhong)药(yao)(yao)材、中(zhong)药(yao)(yao)饮片、中(zhong)间产(chan)(chan)品(pin)和制(zhi)剂等在(zai)内的完整的内控(kong)质(zhi)(zhi)量(liang)标准体系(xi),保持药(yao)(yao)品(pin)批间质(zhi)(zhi)量(liang)稳(wen)定可控(kong)。推动中(zhong)药(yao)(yao)制(zhi)药(yao)(yao)技术升级,鼓励生(sheng)产(chan)(chan)企(qi)业逐步实现智(zhi)能制(zhi)造。

(十一)加强(qiang)上市(shi)后监管(guan)。组(zu)织(zhi)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)专项(xiang)检(jian)查,持续加大中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)药(yao)和中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)饮片(pian)抽检(jian)力度,持续排查化解风险(xian)隐患,依法处置违(wei)(wei)法违(wei)(wei)规企(qi)业(ye)。聚焦掺杂使假、染色增重、非(fei)法添加、非(fei)法渠道购入(ru)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)饮片(pian)等问题(ti),开展中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)饮片(pian)质量(liang)集中(zhong)(zhong)(zhong)(zhong)(zhong)整(zheng)治(zhi),严厉(li)打(da)击违(wei)(wei)法违(wei)(wei)规行为。推动地(di)方(fang)政(zheng)府(fu)落实地(di)方(fang)监管(guan)责任(ren),加强(qiang)对(dui)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)材交易市(shi)场的(de)(de)监管(guan),严厉(li)打(da)击无(wu)证销售中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)饮片(pian)行为,持续净化市(shi)场秩序。基于中(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)发展实际,研究完(wan)善(shan)按照(zhao)省级饮片(pian)炮制规范(fan)生产中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)饮片(pian)的(de)(de)流(liu)通政(zheng)策。强(qiang)化中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)不(bu)良反应监测,对(dui)监测中(zhong)(zhong)(zhong)(zhong)(zhong)发现(xian)的(de)(de)风险(xian)信号(hao)及时组(zu)织(zhi)评估并采取风险(xian)控(kong)制措施。加强(qiang)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)说(shuo)明书和标签(qian)管(guan)理,推进(jin)对(dui)已上市(shi)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)说(shuo)明书中(zhong)(zhong)(zhong)(zhong)(zhong)【禁忌】【不(bu)良反应】【注意事(shi)项(xiang)】等相(xiang)关内容的(de)(de)修改完(wan)善(shan)。

(十(shi)二)加大(da)保(bao)护中药(yao)(yao)品种力度。修(xiu)订《中药(yao)(yao)品种保(bao)护条例》,将中药(yao)(yao)品种保(bao)护制度与专利保(bao)护制度有机衔接,并纳(na)入中药(yao)(yao)全(quan)生命(ming)周期注册(ce)管理之中,发挥其对中药(yao)(yao)创(chuang)新药(yao)(yao)、中药(yao)(yao)改良型新药(yao)(yao)以及古代经典名方中药(yao)(yao)复方制剂等中药(yao)(yao)品种的(de)保(bao)护作用。支持(chi)药(yao)(yao)品上市(shi)许可持(chi)有人(ren)或申(shen)请(qing)人(ren)按(an)有关规定进行相关专利信息的(de)登记、声明。

五、注重(zhong)多方协调联动

(十三)加强(qiang)横向联(lian)系。积极按(an)照国务(wu)(wu)院中(zhong)医药工(gong)作部(bu)际联(lian)席会议部(bu)署,加强(qiang)与科技(ji)、卫(wei)生健康、中(zhong)医药、医保等(deng)部(bu)门的沟通协调,形成(cheng)部(bu)门工(gong)作合力(li),推进国家重(zhong)大(da)科技(ji)项目的成(cheng)果转化,满足临(lin)床需求,积极服务(wu)(wu)中(zhong)药产业(ye)高质量发展。

(十(shi)四)督促落实(shi)(shi)各方(fang)责(ze)(ze)任(ren)。压(ya)实(shi)(shi)企业主体责(ze)(ze)任(ren),督促企业牢固树立质量安(an)全(quan)(quan)(quan)(quan)第(di)一责(ze)(ze)任(ren)人意识(shi),履行药品全(quan)(quan)(quan)(quan)生命周期(qi)管(guan)理责(ze)(ze)任(ren),推(tui)进中(zhong)药企业诚信体系建设(she)。全(quan)(quan)(quan)(quan)面落实(shi)(shi)“四个(ge)最严”的要求,切实(shi)(shi)承担起药品监管(guan)责(ze)(ze)任(ren),牢牢守住药品安(an)全(quan)(quan)(quan)(quan)底线。推(tui)动(dong)地方(fang)党委政府扛起药品安(an)全(quan)(quan)(quan)(quan)政治责(ze)(ze)任(ren),强化属(shu)地管(guan)理责(ze)(ze)任(ren)。

(十五(wu))营造良好社会氛围。加大中(zhong)药(yao)(yao)审评(ping)审批改(gai)革宣传(chuan)力度,加强重(zhong)要政(zheng)策、重(zhong)大措施解读,及时回应(ying)社会关切,合理引导各方(fang)预(yu)期,推动形(xing)成全(quan)社会共同参与(yu)中(zhong)药(yao)(yao)传(chuan)承(cheng)创(chuang)新的(de)新格局。

六、推进(jin)中药监(jian)管体系和(he)监(jian)管能力现代化

(十六)完(wan)(wan)善(shan)中药(yao)(yao)(yao)(yao)法规(gui)(gui)标(biao)(biao)准(zhun)体(ti)系(xi)。加(jia)(jia)快《药(yao)(yao)(yao)(yao)品(pin)管理(li)法》《中医药(yao)(yao)(yao)(yao)法》相关配套规(gui)(gui)章(zhang)制度建(jian)设,健全完(wan)(wan)善(shan)中药(yao)(yao)(yao)(yao)全生命周期监(jian)管制度体(ti)系(xi)。加(jia)(jia)强中药(yao)(yao)(yao)(yao)标(biao)(biao)准(zhun)管理(li),优化国家(jia)药(yao)(yao)(yao)(yao)品(pin)标(biao)(biao)准(zhun)形成(cheng)机制,持续完(wan)(wan)善(shan)以(yi)《中国药(yao)(yao)(yao)(yao)典》为核心的国家(jia)药(yao)(yao)(yao)(yao)品(pin)标(biao)(biao)准(zhun)体(ti)系(xi)。建(jian)立和(he)(he)完(wan)(wan)善(shan)以(yi)临床为导(dao)向(xiang)、符合中医药(yao)(yao)(yao)(yao)特点的中药(yao)(yao)(yao)(yao)质量标(biao)(biao)准(zhun)、技术规(gui)(gui)范(fan)和(he)(he)评价体(ti)系(xi),全面客观反映中药(yao)(yao)(yao)(yao)质量。研究完(wan)(wan)善(shan)中药(yao)(yao)(yao)(yao)材中农(nong)药(yao)(yao)(yao)(yao)残留、重金属与有害元素(su)、真菌毒素(su)等有害物质限量要(yao)求和(he)(he)检测方法。制定(ding)实施(shi)全国中药(yao)(yao)(yao)(yao)饮(yin)(yin)片炮制规(gui)(gui)范(fan)。加(jia)(jia)强地方药(yao)(yao)(yao)(yao)材标(biao)(biao)准(zhun)和(he)(he)省级饮(yin)(yin)片炮制规(gui)(gui)范(fan)的监(jian)督实施(shi)。

(十(shi)七)强(qiang)化技(ji)术(shu)支撑体(ti)(ti)系建(jian)(jian)设(she)。以编(bian)制“十(shi)四五”药(yao)(yao)(yao)品(pin)安(an)全(quan)(quan)(quan)及高质(zhi)量发(fa)展(zhan)规划为契机(ji),开展(zhan)重点(dian)(dian)课题研究(jiu),加强(qiang)检(jian)验检(jian)测(ce)、审评(ping)审批、审核查验、监测(ce)评(ping)价等(deng)重点(dian)(dian)技(ji)术(shu)支撑机(ji)构建(jian)(jian)设(she)。加强(qiang)“智慧监管”建(jian)(jian)设(she),创(chuang)新利用大数据(ju)、互联网、云(yun)计算等(deng)现(xian)代信息技(ji)术(shu),推进(jin)药(yao)(yao)(yao)品(pin)追(zhui)(zhui)(zhui)溯(su)信息互通互享。推动相关(guan)部门共同开展(zhan)中(zhong)(zhong)药(yao)(yao)(yao)材信息化追(zhui)(zhui)(zhui)溯(su)体(ti)(ti)系建(jian)(jian)设(she),进(jin)一步(bu)提高中(zhong)(zhong)药(yao)(yao)(yao)材质(zhi)量安(an)全(quan)(quan)(quan)保障水平。稳步(bu)推进(jin)中(zhong)(zhong)药(yao)(yao)(yao)生(sheng)产企业建(jian)(jian)立药(yao)(yao)(yao)品(pin)追(zhui)(zhui)(zhui)溯(su)体(ti)(ti)系,对中(zhong)(zhong)药(yao)(yao)(yao)产品(pin)赋码、扫码,逐(zhu)步(bu)在(zai)药(yao)(yao)(yao)品(pin)生(sheng)产流通全(quan)(quan)(quan)过程(cheng)实现(xian)可追(zhui)(zhui)(zhui)溯(su)。

(十八)加强(qiang)中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)科(ke)(ke)学(xue)研究(jiu)。鼓励(li)运用现代(dai)科(ke)(ke)学(xue)技术(shu)和(he)传统中(zhong)(zhong)医(yi)药研究(jiu)方法,深(shen)入开展中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)科(ke)(ke)学(xue)研究(jiu),积极推动中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)理念、制度、机(ji)制创新(xin),强(qiang)化成果转化应用,推出一批中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)新(xin)工(gong)具、新(xin)方法和(he)新(xin)标准。深(shen)化与国内一流大(da)学(xue)、科(ke)(ke)研机(ji)构之间合作,建立(li)中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)科(ke)(ke)学(xue)合作研究(jiu)基(ji)地和(he)国家药监(jian)(jian)局重点实验室,强(qiang)化中(zhong)(zhong)药监(jian)(jian)管(guan)(guan)(guan)(guan)基(ji)础(chu)性、战略(lve)性问(wen)题研究(jiu)。

(十九)加强监管队伍(wu)建设。加快职(zhi)(zhi)(zhi)业(ye)化(hua)(hua)、专业(ye)化(hua)(hua)的中药审评员、检查员队伍(wu)建设,完(wan)善分(fen)级(ji)分(fen)类(lei)管理(li)(li)制(zhi)度,明确岗(gang)位准入(ru)和任职(zhi)(zhi)(zhi)条件(jian)。科学(xue)合(he)理(li)(li)开展中药专业(ye)人员的考核评价和职(zhi)(zhi)(zhi)级(ji)升(sheng)降,扩宽(kuan)职(zhi)(zhi)(zhi)业(ye)发展空间,完(wan)善薪酬待遇保(bao)障机制(zhi),确保(bao)高层次人才“招得(de)来、留得(de)住”。  

(二十)积极推(tui)动(dong)国(guo)(guo)际(ji)(ji)传统(tong)药(yao)监管合(he)作(zuo)(zuo)。深化与(yu)世界(jie)卫生组(zu)织(WHO)合(he)作(zuo)(zuo),积极开展与(yu)国(guo)(guo)际(ji)(ji)草药(yao)监管合(he)作(zuo)(zuo)组(zu)织(IRCH)、西太(tai)区草药(yao)监管协(xie)调论坛(FHH)等传统(tong)药(yao)监管国(guo)(guo)际(ji)(ji)组(zu)织以及有关国(guo)(guo)家或地区药(yao)品(pin)监管、药(yao)典机构的交(jiao)流,深入参与(yu)国(guo)(guo)际(ji)(ji)传统(tong)药(yao)相关政策规则制定、标(biao)准(zhun)协(xie)调,推(tui)动(dong)中药(yao)标(biao)准(zhun)国(guo)(guo)际(ji)(ji)化。持续提升(sheng)我国(guo)(guo)中药(yao)监管在(zai)国(guo)(guo)际(ji)(ji)监管组(zu)织中的话(hua)语权(quan),推(tui)动(dong)中医药(yao)更好地为全世界(jie)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