安徽省關于印發推進中藥材生產質量管理規范實施意見的通知

??山東省環境衛生身體健康促進會會   山東省造林局

推進中藥材生產質量管理規范實施意見

????一、總體要求

????二、工作任務

???（一）優化中藥材產業布局。堅持“源頭管(guan)(guan)控，適(shi)宜種植，協(xie)同發(fa)展”原則，根據資(zi)源稟(bing)賦條件、生物(wu)資(zi)源環境、中藥(yao)材(cai)(cai)地(di)域適(shi)應(ying)特(te)(te)點，選擇傳統道地(di)產(chan)區(qu)，加強規(gui)劃引領，加快形成布局合(he)理、特(te)(te)色(se)鮮明、品質(zhi)優(you)良、產(chan)量穩定的中藥(yao)材(cai)(cai)生產(chan)新(xin)格局，推(tui)進中藥(yao)材(cai)(cai)基(ji)地(di)化(hua)(hua)、規(gui)模化(hua)(hua)、集約化(hua)(hua)發(fa)展。以亳州現(xian)代(dai)中藥(yao)產(chan)業集聚基(ji)地(di)和大別(bie)山西山藥(yao)庫(ku)為重點，突(tu)出皖南山區(qu)特(te)(te)色(se)藥(yao)材(cai)(cai)優(you)勢，培育中藥(yao)材(cai)(cai)產(chan)地(di)加工示范(fan)企業，加強中藥(yao)材(cai)(cai)產(chan)地(di)趁鮮加工管(guan)(guan)理，形成全鏈(lian)條質(zhi)量安全風險管(guan)(guan)控產(chan)業鏈(lian)發(fa)展體系，培育鑄造“十大皖藥(yao)”品質(zhi)特(te)(te)色(se)，推(tui)動(dong)建立優(you)質(zhi)優(you)價(jia)的中藥(yao)材(cai)(cai)價(jia)格體系。

???（二）切實加強花楸樹種子果苗繁殖基底建造。建立健全中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材種(zhong)(zhong)(zhong)(zhong)子種(zhong)(zhong)(zhong)(zhong)苗(miao)管理制度(du)(du)，有力(li)推(tui)進中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材種(zhong)(zhong)(zhong)(zhong)質資源保護利用(yong)、品(pin)種(zhong)(zhong)(zhong)(zhong)選育、良(liang)(liang)種(zhong)(zhong)(zhong)(zhong)繁(fan)育等工作。以“十大皖藥(yao)(yao)”產業(ye)示范基地(di)建設(she)為依托，積極推(tui)進道(dao)地(di)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材良(liang)(liang)種(zhong)(zhong)(zhong)(zhong)繁(fan)育基地(di)建設(she)。加大技(ji)術(shu)攻關和(he)良(liang)(liang)種(zhong)(zhong)(zhong)(zhong)推(tui)廣(guang)力(li)度(du)(du)，加快推(tui)動品(pin)種(zhong)(zhong)(zhong)(zhong)培優、品(pin)質提升(sheng)(sheng)、品(pin)牌打造(zao)和(he)標準化生產，整(zheng)體提升(sheng)(sheng)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材種(zhong)(zhong)(zhong)(zhong)業(ye)發展(zhan)質量效益和(he)競爭力(li)。引導中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)龍頭企業(ye)或與中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材專(zhuan)業(ye)合(he)作社聯合(he)開展(zhan)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材優良(liang)(liang)品(pin)種(zhong)(zhong)(zhong)(zhong)選育，建立專(zhuan)業(ye)化中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材種(zhong)(zhong)(zhong)(zhong)子種(zhong)(zhong)(zhong)(zhong)苗(miao)生產經營實(shi)體。

???（三）規范中藥材種養植（殖）。加(jia)強(qiang)對(dui)種植過程中(zhong)高毒、劇(ju)毒農(nong)藥的(de)(de)使(shi)用(yong)(yong)(yong)管理(li)，嚴禁在中(zhong)藥材(cai)種植加(jia)工過程中(zhong)使(shi)用(yong)(yong)(yong)國(guo)家明令(ling)禁止(zhi)使(shi)用(yong)(yong)(yong)的(de)(de)農(nong)業投入品。開(kai)展應用(yong)(yong)(yong)仿生(sheng)(sheng)態種植、擬境栽(zai)培(pei)、測土(tu)配方施(shi)肥(fei)等技(ji)術，推(tui)廣有機(ji)肥(fei)替(ti)代(dai)化肥(fei)，積極采取(qu)輪作倒茬(cha)、深耕曬垡、有機(ji)培(pei)肥(fei)等傳統(tong)措施(shi)，集成和示范推(tui)廣土(tu)壤處理(li)、生(sheng)(sheng)物防(fang)治、物理(li)誘殺、科學用(yong)(yong)(yong)藥、統(tong)防(fang)統(tong)治等綠色防(fang)控技(ji)術，提(ti)高病蟲害防(fang)治效率和防(fang)治效果(guo)，減少(shao)(shao)農(nong)藥、化肥(fei)使(shi)用(yong)(yong)(yong)量。嚴禁濫用(yong)(yong)(yong)植物生(sheng)(sheng)長調節劑和除(chu)草劑，減少(shao)(shao)農(nong)田面源污染，切實提(ti)高中(zhong)藥材(cai)種植綠色化水平，增強(qiang)中(zhong)藥材(cai)產品的(de)(de)安全性(xing)。

???（四）規范中藥材采收及產地初加工管理。強化(hua)皖產(chan)(chan)(chan)(chan)道地(di)藥(yao)(yao)(yao)(yao)(yao)材(cai)種植品(pin)(pin)質提升，積極(ji)推動(dong)企(qi)業(ye)(ye)開展中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)采(cai)收初(chu)加(jia)(jia)(jia)工(gong)技(ji)術規范研究，制(zhi)(zhi)(zhi)定(ding)(ding)我省產(chan)(chan)(chan)(chan)地(di)趁鮮切(qie)制(zhi)(zhi)(zhi)品(pin)(pin)種的(de)加(jia)(jia)(jia)工(gong)技(ji)術規程和質量(liang)(liang)標準(zhun)，提高中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)采(cai)收和產(chan)(chan)(chan)(chan)地(di)初(chu)加(jia)(jia)(jia)工(gong)質量(liang)(liang)管理水平。落實《安徽省規范中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)產(chan)(chan)(chan)(chan)地(di)趁鮮切(qie)制(zhi)(zhi)(zhi)工(gong)作指導意見(jian)》相關規定(ding)(ding)，加(jia)(jia)(jia)強趁鮮切(qie)制(zhi)(zhi)(zhi)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)管理，推動(dong)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)生(sheng)產(chan)(chan)(chan)(chan)企(qi)業(ye)(ye)將藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)質量(liang)(liang)管理體(ti)(ti)系向中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)種植加(jia)(jia)(jia)工(gong)環節延伸。中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)生(sheng)產(chan)(chan)(chan)(chan)企(qi)業(ye)(ye)應(ying)當建立(li)完整的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)生(sheng)產(chan)(chan)(chan)(chan)質量(liang)(liang)追(zhui)溯體(ti)(ti)系，中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)產(chan)(chan)(chan)(chan)地(di)地(di)方政(zheng)府應(ying)加(jia)(jia)(jia)強對趁鮮切(qie)制(zhi)(zhi)(zhi)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)生(sheng)產(chan)(chan)(chan)(chan)企(qi)業(ye)(ye)的(de)遴選和管理，促(cu)進中(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)生(sheng)產(chan)(chan)(chan)(chan)加(jia)(jia)(jia)工(gong)與(yu)生(sheng)態(tai)文明建設、鄉村振興(xing)工(gong)作有機結(jie)合(he)。

???（五）鼓勵優先使用符合《中藥材生產質量管理規范》（GAP）要求的中藥材。督促中(zhong)藥(yao)生產企業(ye)落實質量安全(quan)主體責任，鼓勵(li)其(qi)在中(zhong)藥(yao)材產地自建(jian)、共建(jian)符(fu)合GAP要(yao)求(qiu)的(de)中(zhong)藥(yao)材生產基地，將藥(yao)品質量管理體系延(yan)伸到(dao)中(zhong)藥(yao)材產地。使用符(fu)合GAP要(yao)求(qiu)的(de)中(zhong)藥(yao)材的(de)中(zhong)藥(yao)生產企業(ye)，可以按照《公告》中(zhong)相關規定在藥(yao)品標簽上進行標識。各(ge)級藥(yao)品監(jian)管部門在組織實施或(huo)開展(zhan)(zhan)對中(zhong)藥(yao)生產企業(ye)的(de)監(jian)督檢查中(zhong)，應當將其(qi)中(zhong)藥(yao)材采購驗收等情況納入重點，必要(yao)時開展(zhan)(zhan)延(yan)伸檢查，發現不符(fu)合要(yao)求(qiu)的(de)，應當按照《公告》有關要(yao)求(qiu)依法處理。

????三、保障措施

???（一）加強組織領導。《中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材生(sheng)(sheng)產(chan)(chan)質(zhi)量管(guan)(guan)理(li)規(gui)范(fan)》（GAP）是中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材規(gui)范(fan)化(hua)生(sheng)(sheng)產(chan)(chan)和管(guan)(guan)理(li)的(de)(de)基本(ben)要(yao)(yao)求，適用于中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材生(sheng)(sheng)產(chan)(chan)企業(ye)規(gui)范(fan)生(sheng)(sheng)產(chan)(chan)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材的(de)(de)全過程管(guan)(guan)理(li)，是強(qiang)化(hua)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材源頭管(guan)(guan)理(li)的(de)(de)重要(yao)(yao)手段(duan)。推動(dong)GAP實(shi)施，對推動(dong)我省中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)產(chan)(chan)業(ye)高(gao)質(zhi)量發(fa)(fa)展和提升(sheng)“十大(da)皖藥(yao)(yao)(yao)(yao)”產(chan)(chan)業(ye)示(shi)范(fan)基地建設水平，具(ju)有重要(yao)(yao)現實(shi)意義。各(ge)(ge)地、各(ge)(ge)有關部(bu)門要(yao)(yao)強(qiang)化(hua)組織學習(xi)，將(jiang)GAP的(de)(de)實(shi)施與本(ben)地中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)產(chan)(chan)業(ye)發(fa)(fa)展規(gui)劃密切(qie)結合，按照《安徽省促進中(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)(yao)振興發(fa)(fa)展行動(dong)計(ji)劃》（2022—2024年）（皖政辦秘(mi)〔2022〕27號）工作(zuo)要(yao)(yao)求，結合本(ben)地區實(shi)際制定實(shi)施方案，細(xi)化(hua)具(ju)體措施，落實(shi)工作(zuo)責任(ren)，強(qiang)化(hua)用于生(sheng)(sheng)產(chan)(chan)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)、中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)制劑的(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材源頭管(guan)(guan)理(li)。

???（二）搞好攜手推進項目建設。成立省級《中(zhong)藥材生產質量管理規范》(GAP)實(shi)施工作領(ling)導小組(zu)，建立省級牽(qian)頭抓總，市縣級抓落實(shi)的(de)常態化工作機制，組(zu)建專(zhuan)家工作組(zu)，及時研究(jiu)解(jie)決推進過程中(zhong)遇(yu)到的(de)重大問題(ti)。

???（三）加強宣傳引導。各級各部門要(yao)加(jia)大對《中(zhong)藥(yao)(yao)(yao)材(cai)(cai)生(sheng)產(chan)質量管(guan)理(li)規(gui)范》（GAP）的宣貫和(he)培訓力(li)度，廣泛發動和(he)正確引導(dao)中(zhong)藥(yao)(yao)(yao)材(cai)(cai)種(zhong)養植(zhi)（殖）企(qi)業學(xue)習并參與(yu)實施，嚴(yan)格落實其中(zhong)藥(yao)(yao)(yao)材(cai)(cai)質量安全主體責任。充分發揮行(xing)業協會、第三方(fang)檢測機構(gou)和(he)社會公眾的監督作(zuo)用，促進行(xing)業自(zi)律，形(xing)成中(zhong)藥(yao)(yao)(yao)材(cai)(cai)質量安全社會共治新格局。各部門要(yao)結合職責加(jia)強對中(zhong)藥(yao)(yao)(yao)材(cai)(cai)生(sheng)產(chan)企(qi)業相關(guan)技術(shu)和(he)管(guan)理(li)人員的培訓，提高(gao)中(zhong)藥(yao)(yao)(yao)材(cai)(cai)生(sheng)產(chan)管(guan)理(li)規(gui)范化意(yi)識和(he)技術(shu)水平，確保(bao)工作(zuo)取(qu)得實效。