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)(ge)省、自治区、直辖市药(yao)品(pin)监督管理(li)(li)局(ju)(ju),新疆生产(chan)建设兵(bing)团药(yao)品(pin)监督管理(li)(li)局(ju)(ju),局(ju)(ju)机关各(ge)(ge)司局(ju)(ju),各(ge)(ge)直属单位:

中(zhong)(zhong)药(yao)是(shi)中(zhong)(zhong)华民族的瑰(gui)宝,为造福人民健(jian)康作(zuo)出(chu)巨大贡献,特(te)别是(shi)新(xin)冠肺炎(yan)疫(yi)情爆发(fa)以(yi)来(lai),中(zhong)(zhong)药(yao)彰显特(te)色(se)优势,为打赢(ying)疫(yi)情防控阻击战发(fa)挥了(le)重要作(zuo)用。党(dang)中(zhong)(zhong)央(yang)国务院高度重视中(zhong)(zhong)医(yi)药(yao)工作(zuo),特(te)别是(shi)党(dang)的十八大以(yi)来(lai),习(xi)近(jin)平总书记(ji)多次作(zuo)出(chu)重要指(zhi)示(shi)(shi)批(pi)示(shi)(shi),要求改(gai)革(ge)完善中(zhong)(zhong)药(yao)审(shen)评审(shen)批(pi)机制(zhi),为新(xin)时代中(zhong)(zhong)药(yao)传承创新(xin)发(fa)展指(zhi)明了(le)方向、提供了(le)遵循。为进(jin)一(yi)步贯(guan)彻习(xi)近(jin)平总书记(ji)系列重要指(zhi)示(shi)(shi)批(pi)示(shi)(shi)精(jing)神(shen),深(shen)入(ru)落实中(zhong)(zhong)共(gong)中(zhong)(zhong)央(yang)、国务院《关(guan)于促(cu)进(jin)中(zhong)(zhong)医(yi)药(yao)传承创新(xin)发(fa)展的意见(jian)》决(jue)策(ce)部署,结合药(yao)品监(jian)管工作(zuo)实际,提出(chu)以(yi)下意见(jian)。

一、指导思想

以(yi)习近平新时代中(zhong)(zhong)(zhong)(zhong)(zhong)国(guo)特色社会主(zhu)义思(si)(si)(si)想(xiang)为(wei)指导,全(quan)面(mian)贯彻党(dang)的十九(jiu)大和十九(jiu)届二中(zhong)(zhong)(zhong)(zhong)(zhong)、三中(zhong)(zhong)(zhong)(zhong)(zhong)、四(si)中(zhong)(zhong)(zhong)(zhong)(zhong)、五中(zhong)(zhong)(zhong)(zhong)(zhong)全(quan)会精(jing)神,坚(jian)持以(yi)人(ren)民为(wei)中(zhong)(zhong)(zhong)(zhong)(zhong)心(xin)的发展思(si)(si)(si)想(xiang),全(quan)面(mian)落实“四(si)个最严”的要求,促进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)传承(cheng)创新发展。深(shen)化(hua)改(gai)革(ge),健全(quan)符合中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)特点的审(shen)评审(shen)批体(ti)系。传承(cheng)精(jing)华(hua),注重整(zheng)体(ti)观和中(zhong)(zhong)(zhong)(zhong)(zhong)医药(yao)原创思(si)(si)(si)维,促进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)守(shou)正创新。坚(jian)守(shou)底线,强化(hua)中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)质量(liang)安全(quan)监(jian)管(guan)。创新发展,推进中(zhong)(zhong)(zhong)(zhong)(zhong)药(yao)监(jian)管(guan)体(ti)系和监(jian)管(guan)能力现代化(hua)。

二(er)、促进中药(yao)守正创新

(一)坚持以临(lin)床(chuang)(chuang)(chuang)价(jia)值(zhi)(zhi)为(wei)导(dao)向。重视(shi)根据(ju)中(zhong)医药(yao)临(lin)床(chuang)(chuang)(chuang)治疗特(te)点和实际评(ping)估临(lin)床(chuang)(chuang)(chuang)价(jia)值(zhi)(zhi),注(zhu)重满(man)足尚未满(man)足的临(lin)床(chuang)(chuang)(chuang)需(xu)求,制定中(zhong)药(yao)新药(yao)临(lin)床(chuang)(chuang)(chuang)价(jia)值(zhi)(zhi)评(ping)估技(ji)术指导(dao)原则。建立与中(zhong)药(yao)临(lin)床(chuang)(chuang)(chuang)定位相适应、体现(xian)其作用特(te)点和优(you)势的疗效评(ping)价(jia)标准。鼓(gu)励开展以患者为(wei)中(zhong)心的疗效评(ping)价(jia)。探索引(yin)入(ru)真实世界证据(ju)用于支持中(zhong)药(yao)新药(yao)注(zhu)册上市。

(二(er))推动古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)复(fu)(fu)(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)(zhi)。明确古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)复(fu)(fu)(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)研制(zhi)(zhi)(zhi)(zhi)有关技术要求,促进(jin)古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)复(fu)(fu)(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)研发,推进(jin)古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)向新药(yao)转(zhuan)化。会同国(guo)务院(yuan)中(zhong)(zhong)(zhong)(zhong)医药(yao)主管部门,建(jian)立(li)沟(gou)通协调机(ji)制(zhi)(zhi)(zhi)(zhi),组织研究、制(zhi)(zhi)(zhi)(zhi)定古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)关键信息(xi)考证(zheng)意见。建(jian)立(li)与古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)复(fu)(fu)(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)特(te)点相适应(ying)的审评(ping)(ping)模(mo)式(shi),成(cheng)立(li)古(gu)代(dai)(dai)经(jing)(jing)典(dian)(dian)(dian)名(ming)(ming)(ming)方(fang)(fang)(fang)中(zhong)(zhong)(zhong)(zhong)药(yao)复(fu)(fu)(fu)方(fang)(fang)(fang)制(zhi)(zhi)(zhi)(zhi)剂(ji)专家审评(ping)(ping)委员(yuan)会,实施简化审批。

(三)促(cu)进(jin)中药(yao)(yao)创(chuang)新(xin)发(fa)展(zhan)。探索引(yin)入新(xin)工(gong)具、新(xin)方(fang)法、新(xin)技术、新(xin)标准用于中药(yao)(yao)疗(liao)效评价(jia)。推(tui)动开展(zhan)多(duo)区域(yu)临(lin)床(chuang)试验规范性研究能力(li)与体系建(jian)设(she),促(cu)进(jin)中药(yao)(yao)临(lin)床(chuang)研究质量整(zheng)体提升。发(fa)挥医疗(liao)机构中药(yao)(yao)制剂传(chuan)承(cheng)创(chuang)新(xin)发(fa)展(zhan)“孵化器(qi)”作用,鼓励医疗(liao)机构制剂向中药(yao)(yao)新(xin)药(yao)(yao)转化。支持以病(bing)证结合、专(zhuan)(zhuan)病(bing)专(zhuan)(zhuan)药(yao)(yao)或证候类中药(yao)(yao)等多(duo)种方(fang)式开展(zhan)中药(yao)(yao)新(xin)药(yao)(yao)研制。

(四)鼓励二次开发(fa)。制定(ding)中(zhong)药(yao)(yao)改良型(xing)新(xin)药(yao)(yao)研究相(xiang)关(guan)技(ji)术要求,支持运用符合产品(pin)特点的新(xin)技(ji)术、新(xin)工(gong)艺以及体现(xian)临床(chuang)应(ying)用优(you)势和特点的新(xin)剂型(xing)改进已(yi)上市中(zhong)药(yao)(yao)品(pin)种(zhong)。支持同名同方(fang)药(yao)(yao)的研制,促进已(yi)上市中(zhong)药(yao)(yao)同品(pin)种(zhong)的质量竞争(zheng)。优(you)化已(yi)上市中(zhong)药(yao)(yao)变更相(xiang)关(guan)技(ji)术要求。

(五)加强中(zhong)药(yao)安(an)全(quan)性研(yan)究。引导药(yao)品上市(shi)许可持有人(ren)主动开(kai)(kai)展(zhan)中(zhong)药(yao)上市(shi)后(hou)研(yan)究和(he)上市(shi)后(hou)评价。建立符合中(zhong)药(yao)特点的安(an)全(quan)性评价方法(fa)和(he)标准(zhun)体系,建立以中(zhong)医临床(chuang)为导向的中(zhong)药(yao)安(an)全(quan)性分类分级(ji)评价策略。加大对来源(yuan)于古代经典名方、名老中(zhong)医验方、医疗机构制剂(ji)等(deng)具(ju)有人(ren)用(yong)经验的中(zhong)药(yao)新药(yao)安(an)全(quan)性评价技(ji)术标准(zhun)的研(yan)究。根据药(yao)物组方、人(ren)用(yong)经验、制备工艺、用(yong)法(fa)用(yong)量、功能主治特点等(deng),在临床(chuang)试验期(qi)间或上市(shi)后(hou),开(kai)(kai)展(zhan)各阶段相应的非临床(chuang)和(he)临床(chuang)安(an)全(quan)性研(yan)究。

三(san)、健全符合中(zhong)药(yao)特点的审评审批体系

(六)改革(ge)中(zhong)药(yao)注(zhu)册(ce)(ce)分类。尊重中(zhong)医(yi)药(yao)特点,遵循中(zhong)药(yao)研(yan)制规律,将“安全、有效、质量(liang)可控(kong)”的药(yao)品基本(ben)要求与中(zhong)医(yi)药(yao)传承创新(xin)发展独特的理论体系和(he)实(shi)践特点有机(ji)结合。根据(ju)中(zhong)药(yao)注(zhu)册(ce)(ce)产品特性、创新(xin)程度(du)和(he)研(yan)制实(shi)践情况,改革(ge)中(zhong)药(yao)注(zhu)册(ce)(ce)分类,不(bu)再仅以物质基础作为(wei)划分注(zhu)册(ce)(ce)类别的依据(ju),开辟具(ju)有中(zhong)医(yi)药(yao)特色的注(zhu)册(ce)(ce)申(shen)报路径。

(七)构建(jian)“三(san)结合”审(shen)评证(zheng)据体系(xi)。进(jin)一(yi)步重(zhong)视人(ren)用(yong)经验对(dui)中(zhong)药安全性(xing)、有效性(xing)的支持(chi)作用(yong),按照中(zhong)药特点、研发规律和实际,构建(jian)中(zhong)医药理论、人(ren)用(yong)经验和临床试验相结合的审(shen)评证(zheng)据体系(xi)。加(jia)强对(dui)人(ren)用(yong)经验的规范收集(ji)整理,规范申报资料要求。

(八)改革完(wan)善中(zhong)药(yao)审(shen)评审(shen)批(pi)制度。对(dui)临(lin)床(chuang)(chuang)定位清晰且具有明显(xian)(xian)临(lin)床(chuang)(chuang)价值,用(yong)于重(zhong)(zhong)大疾病、罕见病防(fang)治(zhi)、临(lin)床(chuang)(chuang)急需(xu)而市场短(duan)缺、或属于儿(er)童用(yong)药(yao)的(de)(de)中(zhong)药(yao)新(xin)药(yao)申请实行优先审(shen)评审(shen)批(pi)。对(dui)治(zhi)疗(liao)严重(zhong)(zhong)危及(ji)生(sheng)命且尚无有效(xiao)治(zhi)疗(liao)手段的(de)(de)疾病以及(ji)国务(wu)院卫(wei)生(sheng)健康或中(zhong)医药(yao)主(zhu)(zhu)管部门(men)认定为急需(xu)的(de)(de)中(zhong)药(yao),药(yao)物临(lin)床(chuang)(chuang)试验(yan)已有数据或高质量中(zhong)药(yao)人用(yong)经验(yan)证据显(xian)(xian)示(shi)疗(liao)效(xiao)并能预(yu)测(ce)其临(lin)床(chuang)(chuang)价值的(de)(de),可以附条件批(pi)准。对(dui)突发(fa)重(zhong)(zhong)大公(gong)共卫(wei)生(sheng)事件中(zhong)应急所需(xu)的(de)(de)已上市中(zhong)药(yao)增加功能主(zhu)(zhu)治(zhi)实施特别(bie)审(shen)批(pi)。

四、强化(hua)中药质量安全监管

(九)加强中(zhong)(zhong)(zhong)药(yao)(yao)(yao)质(zhi)量(liang)(liang)(liang)(liang)源(yuan)(yuan)头管(guan)(guan)理。修订中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)生产(chan)质(zhi)量(liang)(liang)(liang)(liang)管(guan)(guan)理规范(GAP),制(zhi)定中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)生产(chan)质(zhi)量(liang)(liang)(liang)(liang)管(guan)(guan)理规范实施指南,引导促进(jin)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)规范化(hua)种(zhong)植养殖,推动(dong)中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)产(chan)地加工(gong),鼓励中(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮片(pian)(pian)(pian)企业将质(zhi)量(liang)(liang)(liang)(liang)保(bao)障体(ti)系向种(zhong)植加工(gong)环节延伸(shen),从源(yuan)(yuan)头加强中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮片(pian)(pian)(pian)质(zhi)量(liang)(liang)(liang)(liang)控(kong)制(zhi)。加强和(he)规范中(zhong)(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)用中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)(zhong)药(yao)(yao)(yao)饮片(pian)(pian)(pian)的质(zhi)量(liang)(liang)(liang)(liang)管(guan)(guan)理,明确质(zhi)量(liang)(liang)(liang)(liang)控(kong)制(zhi)研究相(xiang)关技术(shu)要求。保(bao)护野生药(yao)(yao)(yao)材(cai)(cai)资(zi)源(yuan)(yuan),严格限定使用濒(bin)危野生动(dong)、植物药(yao)(yao)(yao)材(cai)(cai)。加强开展中(zhong)(zhong)(zhong)药(yao)(yao)(yao)新(xin)药(yao)(yao)(yao)资(zi)源(yuan)(yuan)评估,保(bao)障中(zhong)(zhong)(zhong)药(yao)(yao)(yao)材(cai)(cai)来(lai)源(yuan)(yuan)稳定和(he)资(zi)源(yuan)(yuan)可持续利用。

(十(shi))加强生产(chan)(chan)全过(guo)程(cheng)的(de)质(zhi)(zhi)量(liang)控(kong)制(zhi)。加大飞行(xing)检查(cha)力度,严格(ge)执行(xing)药(yao)(yao)品生产(chan)(chan)质(zhi)(zhi)量(liang)管理规范(fan)(GMP)。在传承中药(yao)(yao)饮片传统(tong)炮制(zhi)方法和经验基础上,修(xiu)订药(yao)(yao)品生产(chan)(chan)质(zhi)(zhi)量(liang)管理规范(fan)中药(yao)(yao)饮片附录。持续修(xiu)订完善(shan)包括中药(yao)(yao)材、中药(yao)(yao)饮片、中间(jian)产(chan)(chan)品和制(zhi)剂(ji)等在内的(de)完整的(de)内控(kong)质(zhi)(zhi)量(liang)标(biao)准体系,保持药(yao)(yao)品批(pi)间(jian)质(zhi)(zhi)量(liang)稳定(ding)可控(kong)。推动中药(yao)(yao)制(zhi)药(yao)(yao)技术升级,鼓励生产(chan)(chan)企(qi)业逐步实现(xian)智(zhi)能制(zhi)造。

(十一(yi))加(jia)(jia)(jia)强(qiang)上(shang)(shang)市后监管(guan)。组(zu)织中(zhong)(zhong)(zhong)药(yao)专项检查,持续加(jia)(jia)(jia)大中(zhong)(zhong)(zhong)成药(yao)和(he)中(zhong)(zhong)(zhong)药(yao)饮(yin)(yin)(yin)片(pian)抽检力度,持续排查化解风(feng)险(xian)隐患,依法处置违(wei)(wei)法违(wei)(wei)规企业(ye)。聚(ju)焦(jiao)掺杂使假、染色(se)增(zeng)重(zhong)、非法添加(jia)(jia)(jia)、非法渠(qu)道购入中(zhong)(zhong)(zhong)药(yao)饮(yin)(yin)(yin)片(pian)等问(wen)题,开(kai)展(zhan)中(zhong)(zhong)(zhong)药(yao)饮(yin)(yin)(yin)片(pian)质量集中(zhong)(zhong)(zhong)整治(zhi),严(yan)厉打(da)击违(wei)(wei)法违(wei)(wei)规行为。推(tui)动地(di)方(fang)政府落实(shi)地(di)方(fang)监管(guan)责任,加(jia)(jia)(jia)强(qiang)对中(zhong)(zhong)(zhong)药(yao)材交易(yi)市场的(de)监管(guan),严(yan)厉打(da)击无证(zheng)销售中(zhong)(zhong)(zhong)药(yao)饮(yin)(yin)(yin)片(pian)行为,持续净化市场秩(zhi)序(xu)。基于中(zhong)(zhong)(zhong)医(yi)药(yao)发(fa)展(zhan)实(shi)际,研究完善(shan)按照省级(ji)饮(yin)(yin)(yin)片(pian)炮制规范生产中(zhong)(zhong)(zhong)药(yao)饮(yin)(yin)(yin)片(pian)的(de)流(liu)通政策。强(qiang)化中(zhong)(zhong)(zhong)药(yao)不良(liang)反(fan)应监测,对监测中(zhong)(zhong)(zhong)发(fa)现的(de)风(feng)险(xian)信号及时组(zu)织评估(gu)并采(cai)取(qu)风(feng)险(xian)控制措施。加(jia)(jia)(jia)强(qiang)中(zhong)(zhong)(zhong)药(yao)说明书和(he)标签(qian)管(guan)理(li),推(tui)进对已(yi)上(shang)(shang)市中(zhong)(zhong)(zhong)药(yao)说明书中(zhong)(zhong)(zhong)【禁忌】【不良(liang)反(fan)应】【注(zhu)意事项】等相关内容(rong)的(de)修改完善(shan)。

(十二(er))加大保(bao)护中(zhong)药(yao)(yao)品种(zhong)(zhong)力(li)度(du)。修订(ding)《中(zhong)药(yao)(yao)品种(zhong)(zhong)保(bao)护条例》,将中(zhong)药(yao)(yao)品种(zhong)(zhong)保(bao)护制度(du)与专利(li)(li)保(bao)护制度(du)有机衔(xian)接,并纳入中(zhong)药(yao)(yao)全生命(ming)周期(qi)注册管理之中(zhong),发挥(hui)其对(dui)中(zhong)药(yao)(yao)创新药(yao)(yao)、中(zhong)药(yao)(yao)改良型新药(yao)(yao)以及古代经(jing)典名(ming)方(fang)中(zhong)药(yao)(yao)复(fu)方(fang)制剂等中(zhong)药(yao)(yao)品种(zhong)(zhong)的保(bao)护作用。支持药(yao)(yao)品上(shang)市(shi)许(xu)可(ke)持有人(ren)或申请(qing)人(ren)按有关规定(ding)进行相(xiang)关专利(li)(li)信息的登记(ji)、声明。

五、注(zhu)重多方协调联动(dong)

(十三)加强横向联(lian)系。积(ji)极按照国务(wu)院中医药工作部际联(lian)席会议部署,加强与科技、卫生健康、中医药、医保等部门的(de)沟通协调(diao),形成部门工作合力,推进国家(jia)重大(da)科技项(xiang)目的(de)成果(guo)转化,满足临床需求,积(ji)极服务(wu)中药产业(ye)高质(zhi)量(liang)发展。

(十四(si))督促落实(shi)各方责(ze)(ze)任(ren)。压实(shi)企业主体责(ze)(ze)任(ren),督促企业牢固树(shu)立质量安(an)全第(di)一责(ze)(ze)任(ren)人意识,履行药(yao)品全生命周期管(guan)理责(ze)(ze)任(ren),推进中药(yao)企业诚信(xin)体系建设。全面落实(shi)“四(si)个(ge)最严”的要求,切实(shi)承担起(qi)药(yao)品监管(guan)责(ze)(ze)任(ren),牢牢守(shou)住药(yao)品安(an)全底(di)线。推动地(di)方党委政府扛起(qi)药(yao)品安(an)全政治责(ze)(ze)任(ren),强化属地(di)管(guan)理责(ze)(ze)任(ren)。

(十五)营造良好社(she)会(hui)氛(fen)围。加大中药审(shen)评审(shen)批改革宣传力度,加强(qiang)重要政(zheng)策、重大措施解(jie)读,及时回应社(she)会(hui)关切,合理引导各(ge)方预期(qi),推动形成全(quan)社(she)会(hui)共同参与中药传承(cheng)创新的新格局。

六、推进中(zhong)药监管体系和监管能力现代(dai)化

(十六)完(wan)善(shan)中(zhong)(zhong)药(yao)(yao)法(fa)规(gui)(gui)标准(zhun)体系。加快《药(yao)(yao)品管理法(fa)》《中(zhong)(zhong)医药(yao)(yao)法(fa)》相关配套规(gui)(gui)章(zhang)制(zhi)(zhi)度建设(she),健全完(wan)善(shan)中(zhong)(zhong)药(yao)(yao)全生命周(zhou)期监(jian)管制(zhi)(zhi)度体系。加强(qiang)中(zhong)(zhong)药(yao)(yao)标准(zhun)管理,优化国(guo)家(jia)药(yao)(yao)品标准(zhun)形成机(ji)制(zhi)(zhi),持(chi)续完(wan)善(shan)以(yi)《中(zhong)(zhong)国(guo)药(yao)(yao)典》为核心(xin)的国(guo)家(jia)药(yao)(yao)品标准(zhun)体系。建立(li)和(he)完(wan)善(shan)以(yi)临床为导向、符合中(zhong)(zhong)医药(yao)(yao)特(te)点的中(zhong)(zhong)药(yao)(yao)质量(liang)标准(zhun)、技术(shu)规(gui)(gui)范和(he)评价体系,全面客观(guan)反映中(zhong)(zhong)药(yao)(yao)质量(liang)。研(yan)究完(wan)善(shan)中(zhong)(zhong)药(yao)(yao)材(cai)中(zhong)(zhong)农药(yao)(yao)残留、重金属与有害元素(su)、真菌毒素(su)等有害物(wu)质限量(liang)要求和(he)检测(ce)方法(fa)。制(zhi)(zhi)定实(shi)(shi)施全国(guo)中(zhong)(zhong)药(yao)(yao)饮片(pian)炮制(zhi)(zhi)规(gui)(gui)范。加强(qiang)地方药(yao)(yao)材(cai)标准(zhun)和(he)省级饮片(pian)炮制(zhi)(zhi)规(gui)(gui)范的监(jian)督(du)实(shi)(shi)施。

(十七)强(qiang)化技(ji)术支撑体系建(jian)设(she)。以编制“十四(si)五”药(yao)(yao)品(pin)安全(quan)(quan)及(ji)高质量发展规划(hua)为契机,开(kai)展重(zhong)点(dian)课题研(yan)究,加强(qiang)检验检测、审评审批、审核(he)查验、监(jian)测评价(jia)等重(zhong)点(dian)技(ji)术支撑机构建(jian)设(she)。加强(qiang)“智慧监(jian)管”建(jian)设(she),创(chuang)新利用大数(shu)据、互(hu)联网、云(yun)计算等现(xian)代信(xin)息技(ji)术,推进(jin)药(yao)(yao)品(pin)追(zhui)溯(su)信(xin)息互(hu)通(tong)互(hu)享(xiang)。推动相关部门共同开(kai)展中药(yao)(yao)材信(xin)息化追(zhui)溯(su)体系建(jian)设(she),进(jin)一(yi)步(bu)提(ti)高中药(yao)(yao)材质量安全(quan)(quan)保障水平。稳步(bu)推进(jin)中药(yao)(yao)生产企业建(jian)立(li)药(yao)(yao)品(pin)追(zhui)溯(su)体系,对中药(yao)(yao)产品(pin)赋(fu)码、扫(sao)码,逐步(bu)在药(yao)(yao)品(pin)生产流通(tong)全(quan)(quan)过程实现(xian)可(ke)追(zhui)溯(su)。

(十八(ba))加(jia)强中(zhong)药(yao)(yao)监管科(ke)(ke)学(xue)研(yan)究(jiu)(jiu)。鼓(gu)励运用(yong)现代科(ke)(ke)学(xue)技术和传(chuan)统中(zhong)医(yi)药(yao)(yao)研(yan)究(jiu)(jiu)方(fang)法,深(shen)入(ru)开展中(zhong)药(yao)(yao)监管科(ke)(ke)学(xue)研(yan)究(jiu)(jiu),积极(ji)推(tui)动中(zhong)药(yao)(yao)监管理念、制度、机制创新(xin),强化成果转(zhuan)化应用(yong),推(tui)出一(yi)批中(zhong)药(yao)(yao)监管新(xin)工具、新(xin)方(fang)法和新(xin)标准。深(shen)化与国内一(yi)流大学(xue)、科(ke)(ke)研(yan)机构之间合作,建立中(zhong)药(yao)(yao)监管科(ke)(ke)学(xue)合作研(yan)究(jiu)(jiu)基(ji)地和国家药(yao)(yao)监局重(zhong)点(dian)实验室,强化中(zhong)药(yao)(yao)监管基(ji)础性(xing)、战略性(xing)问题研(yan)究(jiu)(jiu)。

(十(shi)九)加强监管队伍建(jian)设(she)。加快职业化(hua)、专业化(hua)的(de)中(zhong)药(yao)审评(ping)员、检查员队伍建(jian)设(she),完善(shan)分级(ji)分类(lei)管理制度,明确(que)岗位准入(ru)和任职条件。科学(xue)合理开展(zhan)中(zhong)药(yao)专业人员的(de)考核评(ping)价和职级(ji)升降,扩(kuo)宽(kuan)职业发展(zhan)空间,完善(shan)薪酬待遇(yu)保(bao)障机制,确(que)保(bao)高层次人才“招得(de)来、留得(de)住(zhu)”。  

(二十(shi))积(ji)极推动国(guo)际(ji)(ji)传(chuan)统药(yao)监(jian)(jian)(jian)管(guan)(guan)合(he)作(zuo)。深(shen)化与世界卫生组(zu)织(WHO)合(he)作(zuo),积(ji)极开展与国(guo)际(ji)(ji)草药(yao)监(jian)(jian)(jian)管(guan)(guan)合(he)作(zuo)组(zu)织(IRCH)、西太区(qu)草药(yao)监(jian)(jian)(jian)管(guan)(guan)协调论坛(FHH)等传(chuan)统药(yao)监(jian)(jian)(jian)管(guan)(guan)国(guo)际(ji)(ji)组(zu)织以及有关国(guo)家或地区(qu)药(yao)品监(jian)(jian)(jian)管(guan)(guan)、药(yao)典(dian)机构的交(jiao)流,深(shen)入(ru)参(can)与国(guo)际(ji)(ji)传(chuan)统药(yao)相(xiang)关政(zheng)策规则制定(ding)、标(biao)准协调,推动中(zhong)药(yao)标(biao)准国(guo)际(ji)(ji)化。持续提升我国(guo)中(zhong)药(yao)监(jian)(jian)(jian)管(guan)(guan)在国(guo)际(ji)(ji)监(jian)(jian)(jian)管(guan)(guan)组(zu)织中(zhong)的话语权,推动中(zhong)医(yi)药(yao)更好地为全世界人(ren)民(min)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