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國家食藥監總局標準整合精簡:涵蓋醫療器械、化妝品共計700余項

2016-04-06 作者: 瀏覽數:964

為貫(guan)徹落實《國(guo)務院關于印發深化標準(zhun)(zhun)化工(gong)(gong)作改(gai)革方案的通(tong)知》(國(guo)發〔2015〕13號)和《國(guo)務院辦公廳關于印發強(qiang)制性標準(zhun)(zhun)整(zheng)合(he)精簡(jian)工(gong)(gong)作方案的通(tong)知》(國(guo)辦發〔2016〕3號)的要求(qiu),近(jin)期,食品(pin)藥品(pin)監管總(zong)局(ju)部署開展了相關強(qiang)制性標準(zhun)(zhun)整(zheng)合(he)精簡(jian)工(gong)(gong)作。

  這(zhe)次(ci)工(gong)(gong)(gong)作(zuo)(zuo)涉及(ji)的標(biao)(biao)(biao)準(zhun)(zhun)種類繁雜,整(zheng)(zheng)合精簡任務(wu)時間緊、要(yao)求(qiu)高、工(gong)(gong)(gong)作(zuo)(zuo)量大。按照“統(tong)一(yi)(yi)管理、分工(gong)(gong)(gong)負責”的原則,科技標(biao)(biao)(biao)準(zhun)(zhun)司(si)會(hui)同(tong)藥化(hua)注冊司(si)、器(qi)(qi)械(xie)(xie)注冊司(si)、藥化(hua)監(jian)管司(si)、器(qi)(qi)械(xie)(xie)監(jian)管司(si)等司(si)局組織開展(zhan)了本(ben)項(xiang)(xiang)工(gong)(gong)(gong)作(zuo)(zuo),制(zhi)(zhi)(zhi)(zhi)(zhi)定并印發(fa)《總局強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)標(biao)(biao)(biao)準(zhun)(zhun)整(zheng)(zheng)合精簡工(gong)(gong)(gong)作(zuo)(zuo)實施細(xi)則》,明確(que)了任務(wu)分工(gong)(gong)(gong)。醫療器(qi)(qi)械(xie)(xie)標(biao)(biao)(biao)準(zhun)(zhun)管理中心、化(hua)妝品(pin)標(biao)(biao)(biao)準(zhun)(zhun)專家委(wei)員會(hui)、各醫療器(qi)(qi)械(xie)(xie)標(biao)(biao)(biao)準(zhun)(zhun)化(hua)技術委(wei)員會(hui)等多家單位參加。整(zheng)(zheng)合精簡范(fan)圍包括醫療器(qi)(qi)械(xie)(xie)強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)國家標(biao)(biao)(biao)準(zhun)(zhun)95項(xiang)(xiang),制(zhi)(zhi)(zhi)(zhi)(zhi)修訂計(ji)劃(hua)32項(xiang)(xiang);強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)行業標(biao)(biao)(biao)準(zhun)(zhun)385項(xiang)(xiang),制(zhi)(zhi)(zhi)(zhi)(zhi)修訂計(ji)劃(hua)79項(xiang)(xiang)。化(hua)妝品(pin)強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)國家標(biao)(biao)(biao)準(zhun)(zhun)10項(xiang)(xiang),制(zhi)(zhi)(zhi)(zhi)(zhi)修訂計(ji)劃(hua)13項(xiang)(xiang)。通過“廢(fei)止一(yi)(yi)批、轉化(hua)一(yi)(yi)批、整(zheng)(zheng)合一(yi)(yi)批、修訂一(yi)(yi)批”的方式,解決強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)標(biao)(biao)(biao)準(zhun)(zhun)存(cun)在的交叉重復矛盾等主要(yao)問題,同(tong)時研究提(ti)出科學合理的強(qiang)(qiang)制(zhi)(zhi)(zhi)(zhi)(zhi)性(xing)(xing)(xing)標(biao)(biao)(biao)準(zhun)(zhun)體系框(kuang)架,確(que)保(bao)在不造成監(jian)管真空、不降(jiang)低安全底(di)線的前提(ti)下,更好地發(fa)揮標(biao)(biao)(biao)準(zhun)(zhun)在推進治(zhi)理體系和治(zhi)理能力現代化(hua)中的基礎(chu)性(xing)(xing)(xing)、戰略性(xing)(xing)(xing)作(zuo)(zuo)用。

 

 原標題:總局開(kai)展強(qiang)制性標準(zhun)整(zheng)合(he)精簡工作

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