J9九游会AG

J9九(jiu)游会AG
行业动态      

完善八大体系 推动《实施意见》落地生效

发布时间:2022-08-06



日前,国务(wu)院办公厅印发(fa)《关于(yu)(yu)全(quan)面加(jia)强药品监(jian)管(guan)(guan)能力(li)建设的(de)(de)(de)实(shi)施意见》(以下简称《实(shi)施意见》)。《实(shi)施意见》是国务(wu)院办公厅印发(fa)的(de)(de)(de)专(zhuan)门(men)针对(dui)药品监(jian)管(guan)(guan)能力(li)建设的(de)(de)(de)政(zheng)策(ce)文件,体(ti)现了党(dang)中央、国务(wu)院对(dui)药品监(jian)管(guan)(guan)工作的(de)(de)(de)高(gao)度(du)重视,对(dui)于(yu)(yu)建立健(jian)全(quan)科学、高(gao)效(xiao)、权(quan)威(wei)的(de)(de)(de)药品监(jian)管(guan)(guan)体(ti)系(xi)具有重大(da)而深远的(de)(de)(de)意义。江(jiang)(jiang)西(xi)省(sheng)药品监(jian)督管(guan)(guan)理局组织全(quan)体(ti)党(dang)员(yuan)干部认(ren)真学习《实(shi)施意见》,并按照强基(ji)础(chu)、补短板(ban)、破瓶(ping)颈、促提升的(de)(de)(de)思路,在联合江(jiang)(jiang)西(xi)省(sheng)发(fa)改委制定(ding)出台《江(jiang)(jiang)西(xi)省(sheng)“十四五”药品安全(quan)及高(gao)质量发(fa)展规划(hua)》过程中,提出完善“八大(da)体(ti)系(xi)”,加(jia)快(kuai)建立健(jian)全(quan)科学、高(gao)效(xiao)、权(quan)威(wei)的(de)(de)(de)药品监(jian)管(guan)(guan)体(ti)系(xi),推(tui)动《实(shi)施意见》落地生效(xiao)。


一、完善推进生物医药产业链高质量发展的政策协同体系


 鼓励生物医(yi)药产(chan)(chan)业(ye)(ye)创(chuang)新发(fa)(fa)展(zhan),推进有(you)关部门(men)出台加快生物医(yi)药产(chan)(chan)业(ye)(ye)发(fa)(fa)展(zhan)的更(geng)多举措,进一(yi)步提(ti)升(sheng)药品监(jian)管(guan)政(zheng)策(ce)、医(yi)疗医(yi)保政(zheng)策(ce)和产(chan)(chan)业(ye)(ye)发(fa)(fa)展(zhan)政(zheng)策(ce)的协同性,推动(dong)生物医(yi)药产(chan)(chan)业(ye)(ye)链更(geng)高质量发(fa)(fa)展(zhan)。持(chi)(chi)续(xu)推进药品审(shen)评审(shen)批制度改革,鼓励药品创(chuang)新发(fa)(fa)展(zhan)。启动(dong)编(bian)制江(jiang)西(xi)省中药配方(fang)颗粒质量标(biao)准,修订《江(jiang)西(xi)省中药饮片(pian)炮制规范》,推进全(quan)省经典名方(fang)等产(chan)(chan)业(ye)(ye)化发(fa)(fa)展(zhan),推动(dong)江(jiang)西(xi)中药产(chan)(chan)业(ye)(ye)继续(xu)保持(chi)(chi)全(quan)国(guo)前(qian)列。积极对接长三角地区、粤港澳(ao)大(da)湾区,出台重(zhong)点产(chan)(chan)业(ye)(ye)园(yuan)发(fa)(fa)展(zhan)扶持(chi)(chi)政(zheng)策(ce),促进生物医(yi)药产(chan)(chan)业(ye)(ye)集群能(neng)级提(ti)升(sheng)。


二、完善符合大市场监管规律的药品监管体系


 推(tui)动(dong)成(cheng)立省(sheng)(sheng)级药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)安(an)全(quan)协调机(ji)构,统筹推(tui)动(dong)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)安(an)全(quan)与(yu)产业高质量发展,强化对地方政(zheng)府履(lv)行药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)安(an)全(quan)责任的(de)(de)(de)绩效(xiao)考评,推(tui)动(dong)落实药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)安(an)全(quan)党政(zheng)同(tong)责。加强市、县(xian)市场监(jian)(jian)管(guan)(guan)部门药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)管(guan)(guan)专业力量配备(bei),确保具备(bei)与(yu)监(jian)(jian)管(guan)(guan)事(shi)权相适(shi)应(ying)的(de)(de)(de)专业监(jian)(jian)管(guan)(guan)队伍(wu)和条件(jian)。制(zhi)定关于药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)管(guan)(guan)事(shi)权划分的(de)(de)(de)指导意见,强化省(sheng)(sheng)、市、县(xian)三级药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)管(guan)(guan)机(ji)构在药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)全(quan)生命周期的(de)(de)(de)监(jian)(jian)管(guan)(guan)协同(tong),逐步构建以省(sheng)(sheng)药(yao)(yao)(yao)监(jian)(jian)局(ju)为(wei)中枢(shu),派出机(ji)构为(wei)延伸,与(yu)市、县(xian)监(jian)(jian)管(guan)(guan)部门高效(xiao)衔接的(de)(de)(de)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)安(an)全(quan)监(jian)(jian)管(guan)(guan)网络,形(xing)成(cheng)全(quan)省(sheng)(sheng)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)管(guan)(guan)工作一盘(pan)棋格(ge)局(ju)。完善(shan)稽查办案机(ji)制(zhi),加强省(sheng)(sheng)、市、县(xian)三级药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)稽查队伍(wu)建设,形(xing)成(cheng)药(yao)(yao)(yao)品(pin)(pin)(pin)(pin)执法(fa)全(quan)省(sheng)(sheng)上(shang)下(xia)联(lian)动(dong)、快速反应(ying)机(ji)制(zhi)。


三、完善适应新时代监管要求的专业化人才队伍体系


 按照(zhao)“提(ti)升(sheng)现(xian)有、补充不足(zu)、优化结构、做好储备(bei)”原(yuan)则(ze),加快(kuai)完善(shan)职(zhi)(zhi)业(ye)(ye)化专业(ye)(ye)化检查员(yuan)(yuan)队伍建设,努力(li)打造一(yi)支以专职(zhi)(zhi)检查员(yuan)(yuan)为(wei)(wei)主体、兼(jian)职(zhi)(zhi)检查员(yuan)(yuan)为(wei)(wei)补充的政(zheng)治过(guo)硬、素质优良、业(ye)(ye)务(wu)精湛(zhan)、廉洁高效的药(yao)品检查员(yuan)(yuan)队伍。建立检查员(yuan)(yuan)分(fen)级分(fen)类管(guan)理制(zhi)度。拓宽检查员(yuan)(yuan)职(zhi)(zhi)业(ye)(ye)发展(zhan)空间,完善(shan)检查员(yuan)(yuan)职(zhi)(zhi)称评审(shen)政(zheng)策(ce),健(jian)全(quan)和(he)完善(shan)薪酬(chou)待遇分(fen)配机(ji)制(zhi),建立检查员(yuan)(yuan)纪律约束和(he)监督机(ji)制(zhi)。推(tui)动实(shi)施监管(guan)队伍专业(ye)(ye)素质提(ti)升(sheng)工程(cheng),有序开展(zhan)各级审(shen)评员(yuan)(yuan)、检验检测人员(yuan)(yuan)、监管(guan)执法(fa)人员(yuan)(yuan)专业(ye)(ye)能(neng)力(li)培训,争取到“十四五”末基本实(shi)现(xian)全(quan)省(sheng)药(yao)品监管(guan)队伍专业(ye)(ye)化。加快(kuai)高层次(ci)人才(cai)(cai)引进,为(wei)(wei)药(yao)品监管(guan)提(ti)供人才(cai)(cai)保障(zhang)和(he)智(zhi)力(li)支持。


四、完善适应治理能力现代化需求的风险防控体系


 加强药(yao)品质(zhi)量安全风(feng)险(xian)(xian)综合研判,形成风(feng)险(xian)(xian)清单(dan),明确监(jian)管(guan)(guan)重点。完善生产(chan)企业风(feng)险(xian)(xian)分(fen)级监(jian)管(guan)(guan)评定标(biao)准,建(jian)立监(jian)管(guan)(guan)级别动态调整(zheng)机制。强化(hua)疫苗、血液(ye)制品、植(zhi)入性医疗器械、特(te)殊(shu)化(hua)妆(zhuang)品等(deng)高风(feng)险(xian)(xian)J9九游会AG产品 监(jian)管(guan)(guan)。建(jian)立互联(lian)网交(jiao)易监(jian)管(guan)(guan)监(jian)测体系,完善线(xian)上线(xian)下协同(tong)监(jian)管(guan)(guan)机制,严厉(li)打击制售假药(yao)、化(hua)妆(zhuang)品违法添(tian)加等(deng)违法行为。构建(jian)统一(yi)的(de)药(yao)物警戒体系,充分(fen)发挥哨点先行优势,强化(hua)主动监(jian)测、识别各类风(feng)险(xian)(xian),实现(xian)全生命周期质(zhi)量安全风(feng)险(xian)(xian)防控(kong)。


五、完善适应产业高质量发展的药品安全技术支撑体系


 整合技(ji)术(shu)审(shen)评(ping)(ping)(ping)、现(xian)场核查、检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)、不良反应(ying)监测(ce)(ce)(ce)(ce)、标准管理等技(ji)术(shu)资源,形成(cheng)(cheng)以省(sheng)级药(yao)(yao)(yao)监部门为(wei)主(zhu)体(ti)、市县为(wei)补(bu)充的(de)事权能(neng)力匹配(pei)、科学高效的(de)审(shen)评(ping)(ping)(ping)工作体(ti)系。加快(kuai)推进江西省(sheng)药(yao)(yao)(yao)品(pin)(pin)检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)研究院(yuan)生物(wu)制(zhi)品(pin)(pin)批签发(fa)实(shi)验(yan)(yan)室(shi)、国(guo)家(jia)药(yao)(yao)(yao)监局中(zhong)成(cheng)(cheng)药(yao)(yao)(yao)质量评(ping)(ping)(ping)价重(zhong)点实(shi)验(yan)(yan)室(shi)建(jian)设(she)(she),实(shi)现(xian)生物(wu)制(zhi)品(pin)(pin)、化学药(yao)(yao)(yao)品(pin)(pin)、中(zhong)药(yao)(yao)(yao)和药(yao)(yao)(yao)包(bao)材检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)能(neng)力全覆盖。高质量完成(cheng)(cheng)江西省(sheng)医疗(liao)(liao)器械检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)中(zhong)心检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)能(neng)力建(jian)设(she)(she)项目,满足医疗(liao)(liao)器械产业(ye)发(fa)展需求。提升化妆品(pin)(pin)检(jian)(jian)(jian)验(yan)(yan)能(neng)力,加快(kuai)建(jian)设(she)(she)化妆品(pin)(pin)禁(jin)限(xian)用物(wu)质检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)和安全评(ping)(ping)(ping)价实(shi)验(yan)(yan)室(shi),补(bu)齐检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)能(neng)力短板(ban)。强化省(sheng)级检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)机(ji)(ji)构对市县级检(jian)(jian)(jian)验(yan)(yan)检(jian)(jian)(jian)测(ce)(ce)(ce)(ce)机(ji)(ji)构的(de)业(ye)务(wu)指导(dao),开(kai)展能(neng)力达标建(jian)设(she)(she)。


六、完善适应大数据应用的药品智慧监管体系


 紧紧围绕国家(jia)药(yao)(yao)(yao)监(jian)(jian)局提(ti)(ti)出(chu)的“大系(xi)统(tong)(tong)、大数(shu)(shu)(shu)据、大平(ping)台”核心任务(wu),应用(yong)大数(shu)(shu)(shu)据、云(yun)计算(suan)、人工(gong)智(zhi)(zhi)能(neng)及区块链(lian)等(deng)技术手(shou)段,形成以许可审(shen)批(pi)、日常(chang)监(jian)(jian)管(guan)、远(yuan)程(cheng)监(jian)(jian)管(guan)、抽(chou)查检验、执法办案(an)、信用(yong)管(guan)理、公共(gong)服务(wu)等(deng)业(ye)务(wu)系(xi)统(tong)(tong)为基础的一(yi)体化(hua)监(jian)(jian)管(guan)平(ping)台,实(shi)(shi)(shi)现药(yao)(yao)(yao)品行业(ye)“全方位(wei)、全环节、全流程(cheng)”智(zhi)(zhi)慧监(jian)(jian)管(guan)目标。完(wan)善“一(yi)企一(yi)档”和(he)(he)数(shu)(shu)(shu)据中心建(jian)设(she),推进(jin)审(shen)评(ping)审(shen)批(pi)和(he)(he)证照(zhao)管(guan)理数(shu)(shu)(shu)字化(hua)、网(wang)络(luo)(luo)化(hua),推进(jin)各层级、各单位(wei)监(jian)(jian)管(guan)业(ye)务(wu)系(xi)统(tong)(tong)互(hu)联(lian)互(hu)通、共(gong)享(xiang)共(gong)用(yong),逐步实(shi)(shi)(shi)现“一(yi)网(wang)通办”“跨省(sheng)通办”。实(shi)(shi)(shi)施“智(zhi)(zhi)慧药(yao)(yao)(yao)店(dian)”建(jian)设(she)工(gong)程(cheng),搭(da)建(jian)线(xian)(xian)上线(xian)(xian)下(xia)一(yi)体化(hua)“智(zhi)(zhi)慧药(yao)(yao)(yao)店(dian)”服务(wu)平(ping)台,使消费者(zhe)购药(yao)(yao)(yao)更方便、更快捷(jie)、更满意。完(wan)成药(yao)(yao)(yao)品、医疗(liao)器(qi)械(xie)、中药(yao)(yao)(yao)饮(yin)片追溯(su)监(jian)(jian)管(guan)系(xi)统(tong)(tong)建(jian)设(she),发挥追溯(su)数(shu)(shu)(shu)据在风(feng)险(xian)防控、J9九游会AG产品 召回、应急处置等(deng)工(gong)作(zuo)(zuo)中的作(zuo)(zuo)用(yong)。坚持以网(wang)管(guan)网(wang),推进(jin)网(wang)络(luo)(luo)监(jian)(jian)测系(xi)统(tong)(tong)建(jian)设(she),提(ti)(ti)高对药(yao)(yao)(yao)品、医疗(liao)器(qi)械(xie)和(he)(he)化(hua)妆品网(wang)络(luo)(luo)交易的监(jian)(jian)管(guan)能(neng)力。


七、完善适应突发公共卫生事件处置的药品安全应急体系


 完善各级人民政府药品(pin)安全事件(jian)应(ying)(ying)急预(yu)(yu)案,健全应(ying)(ying)急管(guan)理机(ji)制。总(zong)结(jie)新(xin)冠肺炎疫情(qing)防控工(gong)作(zuo)经验(yan),强(qiang)化应(ying)(ying)对突(tu)发重特大公共卫生(sheng)(sheng)事件(jian)中(zhong)检验(yan)检测、体系核(he)查、审评(ping)(ping)审批、监测评(ping)(ping)价等(deng)工(gong)作(zuo)统(tong)一指挥与协调。建(jian)立(li)舆(yu)情(qing)信(xin)息(xi)预(yu)(yu)警机(ji)制,开展风险交流(liu)与会(hui)商,及时回应(ying)(ying)社会(hui)关切(qie)。加强(qiang)省级药品(pin)安全应(ying)(ying)急演练(lian)中(zhong)心建(jian)设(she),强(qiang)化重大突(tu)发公共卫生(sheng)(sheng)事件(jian)等(deng)应(ying)(ying)急应(ying)(ying)对能(neng)力(li)培训和实(shi)战演练(lian),推动药品(pin)应(ying)(ying)急演练(lian)常态化,提(ti)高全省药监机(ji)构应(ying)(ying)急处置(zhi)能(neng)力(li)。


八、完善适应综合治理新格局的社会共治体系


 推(tui)进监管科学研(yan)究,建设江西省中(zhong)(zhong)药监管科学、药品监管政策、化妆品监管科学研(yan)究中(zhong)(zhong)心。积极开展药品科普知识(shi)宣(xuan)传(chuan),提高公众(zhong)药品安(an)全认知水平(ping)及风险(xian)防范能(neng)力(li)。充分发挥行(xing)业协会作(zuo)用(yong),促进行(xing)业诚信自律,引导和督促企业依法开展生(sheng)产经(jing)营活(huo)动。


(来(lai)源:医药网(wang))