中國食(shi)品藥(yao)品網訊 廣東(dong)省(sheng)藥(yao)監局組織制定(ding)的(de)《廣東(dong)省(sheng)中藥(yao)材(cai)產地趁鮮(xian)切制工(gong)作指導(dao)意見(jian)（試(shi)行）》（以下簡稱《指導(dao)意見(jian)（試(shi)行）》）于近日印發并試(shi)行2年，以提升中藥(yao)全產業(ye)鏈質量(liang)，解決中藥(yao)材(cai)加(jia)工(gong)過程中因“二次浸(jin)潤”、切制造成成分流失和(he)損耗增大等行業(ye)難題，力爭使廣東(dong)省(sheng)中藥(yao)材(cai)產地趁鮮(xian)加(jia)工(gong)“品種(zhong)基地化(hua)，加(jia)工(gong)規范化(hua)，質量(liang)可追溯(su)，監管成體(ti)系”，逐步實現(xian)中藥(yao)材(cai)產地趁鮮(xian)加(jia)工(gong)與炮制一體(ti)化(hua)的(de)目(mu)標。
據悉(xi)，廣東省(sheng)藥(yao)(yao)監局經(jing)充分研究討(tao)論(lun)，制定中(zhong)藥(yao)(yao)生產(chan)企(qi)業(ye)(ye)開展(zhan)產(chan)地(di)(di)趁鮮(xian)切(qie)(qie)制加(jia)(jia)(jia)工中(zhong)藥(yao)(yao)材(cai)行為(wei)規(gui)(gui)范，并(bing)對中(zhong)藥(yao)(yao)材(cai)產(chan)地(di)(di)趁鮮(xian)切(qie)(qie)制品種(zhong)的(de)質量風(feng)(feng)險(xian)進行研判，建(jian)立《趁鮮(xian)切(qie)(qie)制加(jia)(jia)(jia)工風(feng)(feng)險(xian)管控中(zhong)藥(yao)(yao)材(cai)品種(zhong)目錄》，確立納入(ru)風(feng)(feng)險(xian)管控目錄原(yuan)則，并(bing)建(jian)立目錄動態調(diao)整機制。強調(diao)對生產(chan)條件而非品種(zhong)的(de)限制，以此依據風(feng)(feng)險(xian)管理原(yuan)則，著力規(gui)(gui)范該省(sheng)中(zhong)藥(yao)(yao)生產(chan)企(qi)業(ye)(ye)在全國(guo)各地(di)(di)自建(jian)和采購趁鮮(xian)切(qie)(qie)制中(zhong)藥(yao)(yao)材(cai)行為(wei)，鼓勵資(zi)源要(yao)素(su)向(xiang)源頭集(ji)聚，通過共建(jian)加(jia)(jia)(jia)工點，加(jia)(jia)(jia)工點定點加(jia)(jia)(jia)工等(deng)模式，促進加(jia)(jia)(jia)工點規(gui)(gui)模化、規(gui)(gui)范化發展(zhan)。
廣東省(sheng)藥(yao)監局(ju)通(tong)過(guo)突出可(ke)(ke)行性目標、針(zhen)對性任務、實效(xiao)性要求，明(ming)確加強趁鮮切(qie)制(zhi)加工(gong)(gong)風險(xian)管理(li)，規范加工(gong)(gong)行為，加強趁鮮切(qie)制(zhi)加工(gong)(gong)質(zhi)(zhi)量(liang)(liang)管理(li)，壓實采購鮮切(qie)藥(yao)材的中藥(yao)生產企業主體責任。該(gai)局(ju)從(cong)質(zhi)(zhi)量(liang)(liang)管理(li)體系(xi)延伸和全過(guo)程(cheng)追(zhui)溯對加工(gong)(gong)點(dian)進行監督管理(li)，保證(zheng)中藥(yao)材來源(yuan)質(zhi)(zhi)量(liang)(liang)可(ke)(ke)溯可(ke)(ke)控，并通(tong)過(guo)自(zi)加工(gong)(gong)后(hou)的質(zhi)(zhi)量(liang)(liang)管控檢驗方可(ke)(ke)放行和上市銷售。
據了解(jie)，中(zhong)藥(yao)(yao)生(sheng)產企業在滿足國(guo)(guo)家有關(guan)要求(qiu)(qiu)和(he)本指導意見(jian)的(de)前提下，需(xu)(xu)滿足以下四(si)方面要求(qiu)(qiu)方可開展加工(gong)采購鮮(xian)切藥(yao)(yao)材(cai)：品種基(ji)原需(xu)(xu)符(fu)合《中(zhong)國(guo)(guo)藥(yao)(yao)典》等(deng)國(guo)(guo)家藥(yao)(yao)品標準或(huo)(huo)者省(sheng)、自治區、直轄(xia)市中(zhong)藥(yao)(yao)材(cai)標準或(huo)(huo)中(zhong)藥(yao)(yao)飲片炮制規(gui)范(fan)中(zhong)的(de)相應規(gui)定；中(zhong)藥(yao)(yao)生(sheng)產企業需(xu)(xu)對中(zhong)藥(yao)(yao)材(cai)種植區域進行(xing)評估，在適宜種植區域自建趁(chen)鮮(xian)切制加工(gong)點(dian)或(huo)(huo)采購趁(chen)鮮(xian)切制藥(yao)(yao)材(cai)；種植、采收(shou)、加工(gong)等(deng)行(xing)為(wei)需(xu)(xu)符(fu)合《中(zhong)藥(yao)(yao)材(cai)生(sheng)產質(zhi)量(liang)管理(li)規(gui)范(fan)》（GAP）要求(qiu)(qiu)；中(zhong)藥(yao)(yao)生(sheng)產企業需(xu)(xu)有能力(li)落實鮮(xian)切藥(yao)(yao)材(cai)全過程追溯(su)和(he)質(zhi)量(liang)管理(li)要求(qiu)(qiu)并確保最終產品質(zhi)量(liang)。
據(ju)介紹，廣東省藥(yao)監(jian)局(ju)根(gen)據(ju)《指導意(yi)見（試(shi)行(xing)）》正文內容(rong)，編制(zhi)和公布中(zhong)藥(yao)材(cai)(cai)產地趁(chen)(chen)鮮切(qie)制(zhi)工作相關(guan)附件共6個，對(dui)正文內容(rong)進行(xing)補(bu)充。隨(sui)文發布了首批《趁(chen)(chen)鮮切(qie)制(zhi)加(jia)工風險管控中(zhong)藥(yao)材(cai)(cai)品種(zhong)目(mu)錄》以(yi)及(ji)趁(chen)(chen)鮮切(qie)制(zhi)工作相關(guan)附件，以(yi)便于(yu)中(zhong)藥(yao)生產企業對(dui)照要求開展相關(guan)工作。
同(tong)時(shi)，《指(zhi)導(dao)意見（試行）》要(yao)求各級監管(guan)(guan)部門(men)要(yao)積(ji)極(ji)(ji)作(zuo)為(wei)，主動擔當，組(zu)織(zhi)落實工(gong)作(zuo)任務，要(yao)求積(ji)極(ji)(ji)探索中(zhong)藥(yao)(yao)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)(ye)開展中(zhong)藥(yao)(yao)材產(chan)(chan)(chan)(chan)地(di)趁鮮加工(gong)的(de)監管(guan)(guan)方(fang)式(shi)，加強相關(guan)(guan)中(zhong)藥(yao)(yao)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)(ye)監督管(guan)(guan)理(li)，嚴防不符合(he)要(yao)求、假冒偽劣的(de)產(chan)(chan)(chan)(chan)品(pin)流(liu)入藥(yao)(yao)用渠(qu)道；鼓勵(li)廣(guang)東省內具備產(chan)(chan)(chan)(chan)地(di)加工(gong)生(sheng)(sheng)產(chan)(chan)(chan)(chan)條件和質(zhi)量(liang)管(guan)(guan)理(li)能力的(de)中(zhong)藥(yao)(yao)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)(ye)以及大宗地(di)產(chan)(chan)(chan)(chan)中(zhong)藥(yao)(yao)材綠色(se)標(biao)準(zhun)化種(zhong)植(zhi)養殖基地(di)建設鮮切(qie)藥(yao)(yao)材加工(gong)點；營造良好營商(shang)環境，站(zhan)在(zai)(zai)(zai)厚植(zhi)新(xin)時(shi)期廣(guang)東中(zhong)藥(yao)(yao)產(chan)(chan)(chan)(chan)業(ye)(ye)發(fa)展新(xin)優勢(shi)，促進(jin)形成(cheng)高質(zhi)量(liang)融合(he)發(fa)展的(de)產(chan)(chan)(chan)(chan)業(ye)(ye)生(sheng)(sheng)態高度，為(wei)中(zhong)藥(yao)(yao)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)(ye)提(ti)供政策咨詢服務和技術指(zhi)導(dao)，協(xie)(xie)調解(jie)決其(qi)在(zai)(zai)(zai)中(zhong)藥(yao)(yao)材產(chan)(chan)(chan)(chan)地(di)趁鮮加工(gong)工(gong)作(zuo)中(zhong)遇(yu)到的(de)困難(nan)和問題(ti)；積(ji)極(ji)(ji)探索管(guan)(guan)理(li)模式(shi)，加強與(yu)加工(gong)點所在(zai)(zai)(zai)地(di)政府及相關(guan)(guan)職能部門(men)的(de)溝通(tong)協(xie)(xie)調，推動中(zhong)藥(yao)(yao)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企業(ye)(ye)建立完(wan)善藥(yao)(yao)品(pin)質(zhi)量(liang)追溯體系(xi)，并支持行業(ye)(ye)協(xie)(xie)會、產(chan)(chan)(chan)(chan)業(ye)(ye)聯盟、科研院(yuan)校等整合(he)資(zi)源、搭建平臺，在(zai)(zai)(zai)相關(guan)(guan)方(fang)面發(fa)揮積(ji)極(ji)(ji)作(zuo)用。（陳海榮）
來源：廣東省藥品監督管理局
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