今年以來，市局強(qiang)(qiang)化藥(yao)械(xie)(xie)(xie)全程監(jian)(jian)(jian)管(guan)長效(xiao)(xiao)化，藥(yao)品(pin)監(jian)(jian)(jian)管(guan)效(xiao)(xiao)能提升明顯。一(yi)是深入推進新(xin)版(ban)GMP實(shi)施，4家(jia)無菌藥(yao)品(pin)生(sheng)(sheng)產(chan)(chan)企(qi)(qi)業(ye)19條生(sheng)(sheng)產(chan)(chan)線全部(bu)通(tong)過新(xin)版(ban)GMP認(ren)證(zheng)，非(fei)無菌藥(yao)品(pin)生(sheng)(sheng)產(chan)(chan)車間(jian)通(tong)過新(xin)版(ban)GMP認(ren)證(zheng)的(de)車間(jian)數量為(wei)18個。二是組(zu)織開(kai)(kai)展(zhan)GMP跟蹤(zong)檢(jian)查(cha)(cha)，所(suo)有(you)在產(chan)(chan)生(sheng)(sheng)產(chan)(chan)企(qi)(qi)業(ye)跟蹤(zong)檢(jian)查(cha)(cha)覆(fu)蓋率達到(dao)100%。加(jia)(jia)強(qiang)(qiang)注射劑用(yong)(yong)(yong)玻(bo)璃包裝容器(qi)(qi)管(guan)理，整頓和規(gui)范中藥(yao)生(sheng)(sheng)產(chan)(chan)流通(tong)秩序。三是做好新(xin)版(ban)GSP認(ren)證(zheng)現場(chang)檢(jian)查(cha)(cha)工(gong)作，9家(jia)藥(yao)品(pin)批發(fa)企(qi)(qi)業(ye)通(tong)過現場(chang)檢(jian)查(cha)(cha)，其中6家(jia)企(qi)(qi)業(ye)取得新(xin)版(ban)GSP認(ren)證(zheng)證(zheng)書，另有(you)5家(jia)企(qi)(qi)業(ye)（含(han)零售連鎖）申報(bao)(bao)(bao)材料省局已受理待查(cha)(cha)。四是開(kai)(kai)展(zhan)醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)“五整治”，對826家(jia)醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)、經營(ying)和使(shi)用(yong)(yong)(yong)單(dan)位(wei)(wei)實(shi)施了監(jian)(jian)(jian)督檢(jian)查(cha)(cha)，被(bei)警告(gao)責令(ling)整改的(de)企(qi)(qi)業(ye)、單(dan)位(wei)(wei)158家(jia)。五是利用(yong)(yong)(yong)國(guo)家(jia)局違法廣告(gao)監(jian)(jian)(jian)測(ce)系統，完成藥(yao)品(pin)、醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)、保健食品(pin)等(deng)違法廣告(gao)監(jian)(jian)(jian)測(ce)7975條次(ci)，全部(bu)移(yi)送工(gong)商部(bu)門查(cha)(cha)處(chu)，提請省局暫停銷售2個品(pin)種(zhong)。六是加(jia)(jia)強(qiang)(qiang)藥(yao)品(pin)不(bu)良反(fan)應/事(shi)(shi)件監(jian)(jian)(jian)測(ce)，全市參與在線呈報(bao)(bao)(bao)單(dan)位(wei)(wei)451家(jia)，共上報(bao)(bao)(bao)ADR報(bao)(bao)(bao)告(gao)4671份，其中新(xin)的(de)、嚴重的(de)報(bao)(bao)(bao)告(gao)1796份，占報(bao)(bao)(bao)告(gao)總數38.45%；上報(bao)(bao)(bao)藥(yao)物(wu)濫用(yong)(yong)(yong)調查(cha)(cha)表(biao)238例，報(bao)(bao)(bao)告(gao)及時(shi)性、評價調查(cha)(cha)效(xiao)(xiao)率繼(ji)續位(wei)(wei)列全省前列。七是做好醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)不(bu)良事(shi)(shi)件監(jian)(jian)(jian)測(ce)哨點醫院(yuan)的(de)遴選、培(pei)訓(xun)和管(guan)理，醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)生(sheng)(sheng)產(chan)(chan)、經營(ying)和使(shi)用(yong)(yong)(yong)單(dan)位(wei)(wei)上報(bao)(bao)(bao)醫療(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)疑是不(bu)良事(shi)(shi)件864例。
