湖南懷化市部署推進藥品監管工作和藥品安全鞏固提升行動
2024-05-21 中國質(zhi)量萬里行 點(dian)擊：次
近日(ri)，湖(hu)南省懷化市召(zhao)開藥(yao)品監管(guan)工作暨藥(yao)品安全鞏固提升行動(dong)推進會，總結2023年(nian)工作，分(fen)析形勢查(cha)找不足，部(bu)署2024年(nian)重(zhong)點任務，并(bing)舉(ju)辦藥(yao)品監管(guan)和質量管(guan)理綜(zong)合能力提升培訓。
會(hui)(hui)議(yi)傳達了湖南(nan)省藥(yao)(yao)監局(ju)相關工(gong)作(zuo)(zuo)會(hui)(hui)議(yi)精神和(he)有關領導批示(shi)要(yao)求(qiu)，解讀(du)了2024年全(quan)市藥(yao)(yao)品安全(quan)考核工(gong)作(zuo)(zuo)方案，懷化市紀委(wei)監委(wei)駐局(ju)紀檢(jian)監察組就藥(yao)(yao)品安全(quan)領域群眾身(shen)邊不(bu)正之風和(he)腐敗(bai)問題等方面作(zuo)(zuo)了強調要(yao)求(qiu)和(he)警示(shi)教育(yu)。鶴城區、溆浦縣(xian)、辰(chen)溪縣(xian)、靖州縣(xian)在(zai)會(hui)(hui)上作(zuo)(zuo)經驗交流發言(yan)。
2023年，懷化(hua)市市場監(jian)(jian)管(guan)(guan)部門踐(jian)行(xing)(xing)“四個(ge)最嚴”要求(qiu)，全(quan)(quan)面落實藥(yao)(yao)(yao)(yao)品(pin)安全(quan)(quan)屬地(di)監(jian)(jian)管(guan)(guan)責任(ren)，大(da)力(li)推進藥(yao)(yao)(yao)(yao)品(pin)監(jian)(jian)管(guan)(guan)體系(xi)建(jian)設，創(chuang)新(xin)監(jian)(jian)管(guan)(guan)方式，強化(hua)專項(xiang)整治(zhi)，有效防(fang)控化(hua)解安全(quan)(quan)風(feng)險，實現了“強監(jian)(jian)管(guan)(guan)、保(bao)安全(quan)(quan)、促發(fa)展、提(ti)能(neng)力(li)”工作目標(biao)。全(quan)(quan)市受理(li)藥(yao)(yao)(yao)(yao)品(pin)、醫療(liao)器(qi)械、化(hua)妝(zhuang)品(pin)許可(ke)1064件(jian)，備案406件(jian)；開展藥(yao)(yao)(yao)(yao)品(pin)互聯網銷售監(jian)(jian)管(guan)(guan)1136次(ci)；檢(jian)(jian)查(cha)藥(yao)(yao)(yao)(yao)械化(hua)生產(chan)經營使(shi)用單位1.2萬余家(jia)次(ci)，排除安全(quan)(quan)隱患1700處(chu)，責令整改411家(jia)，采取(qu)告誡、約談等(deng)行(xing)(xing)政(zheng)處(chu)理(li)措施(shi)1655家(jia)，查(cha)辦藥(yao)(yao)(yao)(yao)械化(hua)違(wei)法(fa)案件(jian)423件(jian)，移送司(si)法(fa)機關(guan)10件(jian)；受理(li)處(chu)理(li)相關(guan)投(tou)訴舉報484起；完(wan)善市、縣、鄉鎮(zhen)三級藥(yao)(yao)(yao)(yao)物警戒和(he)不良(liang)反應(ying)監(jian)(jian)測(ce)體系(xi)，高質(zhi)量上(shang)報藥(yao)(yao)(yao)(yao)械化(hua)不良(liang)反應(ying)/事件(jian)報告；舉辦監(jian)(jian)管(guan)(guan)從業人員(yuan)能(neng)力(li)提(ti)升培訓(xun)8期，培訓(xun)1350余人；建(jian)立市級藥(yao)(yao)(yao)(yao)品(pin)流通兼職(zhi)檢(jian)(jian)查(cha)員(yuan)庫(ku)，選聘市級兼職(zhi)藥(yao)(yao)(yao)(yao)品(pin)檢(jian)(jian)查(cha)員(yuan)72名；化(hua)妝(zhuang)品(pin)檢(jian)(jian)驗檢(jian)(jian)測(ce)參數擴項(xiang)242個(ge)；289家(jia)醫療(liao)器(qi)械批發(fa)企(qi)業分級分類(lei)管(guan)(guan)理(li)；對藥(yao)(yao)(yao)(yao)品(pin)生產(chan)企(qi)業和(he)茯(fu)苓、黃柏、黃精等(deng)中藥(yao)(yao)(yao)(yao)材(cai)基地(di)提(ti)供(gong)技術支(zhi)持和(he)中藥(yao)(yao)(yao)(yao)材(cai)標(biao)本基源鑒定；獲(huo)評2023年度(du)全(quan)(quan)省藥(yao)(yao)(yao)(yao)品(pin)安全(quan)(quan)鞏固提(ti)升行(xing)(xing)動先(xian)進縣市區局2個(ge)、湖南省藥(yao)(yao)(yao)(yao)品(pin)稽查(cha)執(zhi)法(fa)“十佳典型案例(li)”1個(ge)。
2024年，懷化(hua)市(shi)藥(yao)(yao)械(xie)化(hua)監(jian)(jian)管(guan)(guan)(guan)(guan)工(gong)作(zuo)和(he)(he)(he)藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)鞏(gong)固提(ti)(ti)升行(xing)動(dong)將(jiang)圍繞八(ba)個方面(mian)發力(li)(li)(li)。一是(shi)(shi)(shi)提(ti)(ti)高站位擔使命。強(qiang)(qiang)化(hua)責(ze)(ze)任意識(shi)和(he)(he)(he)底(di)線思維，增(zeng)強(qiang)(qiang)工(gong)作(zuo)前瞻(zhan)性、敏銳(rui)性、預見(jian)性和(he)(he)(he)主動(dong)性，對(dui)風(feng)險(xian)隱患(huan)實(shi)(shi)時(shi)監(jian)(jian)測(ce)、早期(qi)預警(jing)、精(jing)準處(chu)置(zhi)。二是(shi)(shi)(shi)排(pai)查(cha)隱患(huan)保安(an)(an)全(quan)(quan)(quan)。針對(dui)重(zhong)點(dian)品(pin)(pin)(pin)種、重(zhong)點(dian)環節、重(zhong)點(dian)對(dui)象、重(zhong)點(dian)區域，捕捉日常監(jian)(jian)督(du)檢查(cha)、產(chan)品(pin)(pin)(pin)抽檢、不良(liang)反應監(jian)(jian)測(ce)、投訴(su)(su)舉報(bao)、涉藥(yao)(yao)輿(yu)情中(zhong)(zhong)的(de)風(feng)險(xian)信(xin)息，打好風(feng)險(xian)防控(kong)主動(dong)仗；落實(shi)(shi)藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)風(feng)險(xian)會(hui)商研判工(gong)作(zuo)機制，實(shi)(shi)行(xing)風(feng)險(xian)隱患(huan)臺(tai)賬(zhang)“銷號管(guan)(guan)(guan)(guan)理”，開展(zhan)“回頭看”，督(du)促企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)全(quan)(quan)(quan)面(mian)落實(shi)(shi)藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)主體(ti)(ti)責(ze)(ze)任。三是(shi)(shi)(shi)嚴密布防抓落實(shi)(shi)。嚴格落實(shi)(shi)藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)協調機制，積極推行(xing)“六長”分級負責(ze)(ze)制，強(qiang)(qiang)化(hua)督(du)查(cha)督(du)導(dao)和(he)(he)(he)明察(cha)暗訪工(gong)作(zuo)，及時(shi)通報(bao)發現的(de)問題(ti)，倒逼工(gong)作(zuo)落實(shi)(shi)。四(si)是(shi)(shi)(shi)聚(ju)焦重(zhong)點(dian)強(qiang)(qiang)執法(fa)(fa)。聚(ju)焦問題(ti)短板，實(shi)(shi)現藥(yao)(yao)械(xie)化(hua)安(an)(an)全(quan)(quan)(quan)風(feng)險(xian)排(pai)查(cha)、隱患(huan)處(chu)置(zhi)、違法(fa)(fa)查(cha)辦(ban)、整(zheng)改落實(shi)(shi)四(si)個100%；聚(ju)焦特(te)殊(shu)藥(yao)(yao)品(pin)(pin)(pin)、專(zhuan)管(guan)(guan)(guan)(guan)藥(yao)(yao)品(pin)(pin)(pin)、中(zhong)(zhong)藥(yao)(yao)飲片(pian)、集中(zhong)(zhong)采購中(zhong)(zhong)選藥(yao)(yao)品(pin)(pin)(pin)、植入類醫療(liao)器械(xie)、特(te)殊(shu)用(yong)途和(he)(he)(he)兒童(tong)用(yong)化(hua)妝(zhuang)品(pin)(pin)(pin)等(deng)(deng)高風(feng)險(xian)產(chan)品(pin)(pin)(pin)以及藥(yao)(yao)械(xie)化(hua)網絡(luo)銷售(shou)(shou)，突(tu)出抓網絡(luo)銷售(shou)(shou)監(jian)(jian)測(ce)體(ti)(ti)系建(jian)設(she)(she)、農村(cun)和(he)(he)(he)城(cheng)鄉接(jie)合(he)部(bu)(bu)的(de)監(jian)(jian)管(guan)(guan)(guan)(guan)執法(fa)(fa)以及批(pi)零市(shi)場(chang)和(he)(he)(he)網絡(luo)經(jing)營(ying)知名品(pin)(pin)(pin)牌產(chan)品(pin)(pin)(pin)、宣(xuan)(xuan)稱(cheng)美白產(chan)品(pin)(pin)(pin)的(de)專(zhuan)項整(zheng)治，強(qiang)(qiang)化(hua)對(dui)區縣、基層所執法(fa)(fa)辦(ban)案工(gong)作(zuo)的(de)指(zhi)導(dao)。五(wu)是(shi)(shi)(shi)苦練內功提(ti)(ti)能(neng)力(li)(li)(li)。持(chi)續提(ti)(ti)升檢驗(yan)檢測(ce)能(neng)力(li)(li)(li)，加強(qiang)(qiang)法(fa)(fa)治監(jian)(jian)管(guan)(guan)(guan)(guan)、智慧監(jian)(jian)管(guan)(guan)(guan)(guan)和(he)(he)(he)信(xin)用(yong)監(jian)(jian)管(guan)(guan)(guan)(guan)，不斷優(you)化(hua)藥(yao)(yao)品(pin)(pin)(pin)監(jian)(jian)管(guan)(guan)(guan)(guan)力(li)(li)(li)量(liang)配置(zhi)，強(qiang)(qiang)化(hua)執法(fa)(fa)專(zhuan)業(ye)(ye)(ye)(ye)能(neng)力(li)(li)(li)建(jian)設(she)(she)和(he)(he)(he)基層藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)協管(guan)(guan)(guan)(guan)員(yuan)、信(xin)息員(yuan)隊伍建(jian)設(she)(she)。六是(shi)(shi)(shi)抓實(shi)(shi)主體(ti)(ti)嚴管(guan)(guan)(guan)(guan)理。全(quan)(quan)(quan)面(mian)強(qiang)(qiang)化(hua)企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)主體(ti)(ti)責(ze)(ze)任意識(shi)和(he)(he)(he)企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)法(fa)(fa)人(ren)質量(liang)管(guan)(guan)(guan)(guan)理“第一責(ze)(ze)任人(ren)”意識(shi)，強(qiang)(qiang)化(hua)企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)內部(bu)(bu)培訓，將(jiang)企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)自(zi)查(cha)自(zi)糾情況(kuang)納(na)入企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)績效考核。七是(shi)(shi)(shi)共治共享聚(ju)合(he)力(li)(li)(li)。全(quan)(quan)(quan)面(mian)落實(shi)(shi)部(bu)(bu)門監(jian)(jian)管(guan)(guan)(guan)(guan)責(ze)(ze)任、屬(shu)地(di)(di)管(guan)(guan)(guan)(guan)理責(ze)(ze)任、企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)主體(ti)(ti)責(ze)(ze)任；整(zheng)合(he)安(an)(an)全(quan)(quan)(quan)用(yong)藥(yao)(yao)月(yue)、醫療(liao)器械(xie)安(an)(an)全(quan)(quan)(quan)宣(xuan)(xuan)傳周、化(hua)妝(zhuang)品(pin)(pin)(pin)宣(xuan)(xuan)傳周等(deng)(deng)科普品(pin)(pin)(pin)牌，集中(zhong)(zhong)開展(zhan)科普宣(xuan)(xuan)傳活動(dong)；邀請(qing)行(xing)風(feng)監(jian)(jian)督(du)員(yuan)加強(qiang)(qiang)藥(yao)(yao)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)(quan)監(jian)(jian)督(du)暗訪；暢通投訴(su)(su)舉報(bao)渠道，及時(shi)有效辦(ban)理信(xin)訪舉報(bao)事項。八(ba)是(shi)(shi)(shi)優(you)化(hua)服務(wu)促發展(zhan)。規范行(xing)政審(shen)(shen)(shen)批(pi)行(xing)為(wei)，提(ti)(ti)升審(shen)(shen)(shen)批(pi)效能(neng)，助推大健康產(chan)業(ye)(ye)(ye)(ye)培塑行(xing)動(dong)；加大協助審(shen)(shen)(shen)評審(shen)(shen)(shen)批(pi)支持(chi)力(li)(li)(li)度(du)，助力(li)(li)(li)建(jian)鏈延鏈強(qiang)(qiang)鏈；圍繞本地(di)(di)中(zhong)(zhong)藥(yao)(yao)材(cai)趁鮮加工(gong)、藥(yao)(yao)械(xie)制造、新(xin)建(jian)和(he)(he)(he)改擴建(jian)企(qi)(qi)(qi)業(ye)(ye)(ye)(ye)生(sheng)產(chan)，引(yin)進新(xin)品(pin)(pin)(pin)種、新(xin)工(gong)藝，強(qiang)(qiang)化(hua)政策引(yin)導(dao)、業(ye)(ye)(ye)(ye)務(wu)指(zhi)導(dao)。
在(zai)藥品(pin)監管(guan)和質量管(guan)理綜合能力提升培訓(xun)中，懷化市市場監管(guan)局相(xiang)關負責人就新版《醫(yi)療器械經營質量管(guan)理規范》重點及(ji)如何在(zai)計算機(ji)系統(tong)中操(cao)作實現、藥品(pin)經營使用(yong)監管(guan)要點、化妝品(pin)安全(quan)風險及(ji)典型問題(ti)等內容進行授(shou)課講解。
懷化市(shi)(shi)市(shi)(shi)場監管(guan)(guan)局(ju)相(xiang)關(guan)科室、直(zhi)屬單位工作人(ren)員，下轄縣市(shi)(shi)區市(shi)(shi)場監管(guan)(guan)局(ju)分(fen)管(guan)(guan)領(ling)導(dao)和相(xiang)關(guan)業(ye)務股室負(fu)責人(ren)，藥品批(pi)發、零售連(lian)鎖(suo)企業(ye)及二、三類醫療器械經營批(pi)發企業(ye)相(xiang)關(guan)負(fu)責人(ren)共290余人(ren)參加會議(yi)和培訓。
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