甘肅省(sheng)藥(yao)(yao)品監(jian)督管理局關(guan)于印(yin)發(fa)(fa)促進中醫藥(yao)(yao)傳承創新發(fa)(fa)展若干措施(shi)的通知

甘(gan)藥監發〔2021〕124號

各(ge)市(shi)州市(shi)場監督(du)管理(li)局，省局機關相(xiang)關處、直屬(shu)事業單位：

為深入(ru)貫徹落實(shi)《中(zhong)(zhong)(zhong)(zhong)共(gong)中(zhong)(zhong)(zhong)(zhong)央(yang)國務院關(guan)于促進(jin)中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)傳(chuan)(chuan)承(cheng)(cheng)創(chuang)(chuang)新發展(zhan)的(de)(de)意見》《國家藥(yao)(yao)(yao)品監督管理局關(guan)于促進(jin)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)傳(chuan)(chuan)承(cheng)(cheng)創(chuang)(chuang)新發展(zhan)的(de)(de)實(shi)施意見》《中(zhong)(zhong)(zhong)(zhong)共(gong)甘(gan)肅省委(wei)甘(gan)肅省人民政府關(guan)于促進(jin)中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)傳(chuan)(chuan)承(cheng)(cheng)創(chuang)(chuang)新發展(zhan)的(de)(de)若干措施》《甘(gan)肅省推進(jin)建設國家中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)產業(ye)發展(zhan)綜合試(shi)驗區行動(dong)計劃(hua)（2021-2023）》等有關(guan)要求，持(chi)續深化“放(fang)管服(fu)”改革，圍繞中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)領域(yu)亟待解決(jue)的(de)(de)突出問(wen)題，堅持(chi)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)守正創(chuang)(chuang)新和助推中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)產業(ye)高質(zhi)量發展(zhan)，立(li)足(zu)藥(yao)(yao)(yao)品監管職責和工作實(shi)際，制定如下促進(jin)中(zhong)(zhong)(zhong)(zhong)醫(yi)藥(yao)(yao)(yao)傳(chuan)(chuan)承(cheng)(cheng)創(chuang)(chuang)新發展(zhan)務實(shi)舉措：

一、服務中藥(yao)產業高質(zhi)量發展

1、推(tui)進大宗(zong)地(di)產(chan)(chan)(chan)(chan)中(zhong)(zhong)(zhong)藥(yao)材(cai)產(chan)(chan)(chan)(chan)地(di)加工(gong)(gong)。發(fa)揮甘肅省(sheng)中(zhong)(zhong)(zhong)藥(yao)材(cai)資(zi)源和(he)國家中(zhong)(zhong)(zhong)醫藥(yao)產(chan)(chan)(chan)(chan)業(ye)發(fa)展(zhan)(zhan)綜合(he)試(shi)驗(yan)區優(you)勢，結(jie)合(he)《國家藥(yao)監局綜合(he)司關(guan)于中(zhong)(zhong)(zhong)藥(yao)飲片(pian)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企(qi)業(ye)采購產(chan)(chan)(chan)(chan)地(di)加工(gong)(gong)（趁鮮切制）中(zhong)(zhong)(zhong)藥(yao)材(cai)有(you)關(guan)問題的復函(han)》對甘肅的利好(hao)政(zheng)策，鞏固脫(tuo)貧(pin)攻堅(jian)成(cheng)果、助(zhu)力(li)鄉(xiang)村振興，在(zai)我省(sheng)大宗(zong)地(di)產(chan)(chan)(chan)(chan)中(zhong)(zhong)(zhong)藥(yao)材(cai)主產(chan)(chan)(chan)(chan)區，創新產(chan)(chan)(chan)(chan)業(ye)發(fa)展(zhan)(zhan)模式和(he)監管方式，推(tui)動落實大宗(zong)地(di)產(chan)(chan)(chan)(chan)中(zhong)(zhong)(zhong)藥(yao)材(cai)產(chan)(chan)(chan)(chan)地(di)加工(gong)(gong)舉措，將產(chan)(chan)(chan)(chan)地(di)加工(gong)(gong)中(zhong)(zhong)(zhong)藥(yao)材(cai)作為原料，向全(quan)國中(zhong)(zhong)(zhong)藥(yao)飲片(pian)生(sheng)(sheng)產(chan)(chan)(chan)(chan)企(qi)業(ye)提供，不斷加強從種植到(dao)使用全(quan)過程質量(liang)安全(quan)監管，提高中(zhong)(zhong)(zhong)藥(yao)材(cai)質量(liang)，推(tui)進中(zhong)(zhong)(zhong)藥(yao)產(chan)(chan)(chan)(chan)業(ye)高質量(liang)發(fa)展(zhan)(zhan)。

2、完善(shan)中(zhong)藥(yao)質(zhi)量標準(zhun)體(ti)系。建(jian)立完善(shan)政府(fu)主導(dao)、企(qi)(qi)業(ye)主體(ti)、社(she)會參與(yu)(yu)的相關(guan)標準(zhun)制(zhi)定修訂工(gong)(gong)作機制(zhi)，依據《中(zhong)國藥(yao)典》《甘肅省中(zhong)藥(yao)材標準(zhun)》《甘肅省中(zhong)藥(yao)炮(pao)制(zhi)規范(fan)(fan)》，逐(zhu)步(bu)完善(shan)大宗道(dao)地中(zhong)藥(yao)材產(chan)(chan)地加工(gong)(gong)質(zhi)量標準(zhun)和加工(gong)(gong)技術指導(dao)原則（規范(fan)(fan)），規范(fan)(fan)中(zhong)藥(yao)材種植、加工(gong)(gong)質(zhi)量管控，確保產(chan)(chan)品質(zhi)量符合(he)標準(zhun)。加快中(zhong)藥(yao)配方顆(ke)粒(li)地方標準(zhun)研(yan)發進度，指導(dao)省內中(zhong)藥(yao)配方顆(ke)粒(li)生(sheng)產(chan)(chan)企(qi)(qi)業(ye)制(zhi)定質(zhi)量標準(zhun)，推(tui)動中(zhong)藥(yao)配方顆(ke)粒(li)生(sheng)產(chan)(chan)企(qi)(qi)業(ye)與(yu)(yu)大專院校、科研(yan)機構、醫(yi)療機構進行物質(zhi)基礎研(yan)究。

3、拓(tuo)展技(ji)(ji)術支撐服務領(ling)域。以甘肅(su)省藥(yao)(yao)監(jian)局(ju)與蘭州(zhou)大學(xue)、中國(guo)藥(yao)(yao)科(ke)大學(xue)簽署(shu)的(de)(de)(de)戰略合作協議，積極開展監(jian)管科(ke)學(xue)研(yan)究，通過(guo)成(cheng)立(li)“甘肅(su)省循證藥(yao)(yao)械監(jian)管科(ke)學(xue)研(yan)究院”等(deng)有效舉(ju)措，逐步(bu)拓(tuo)展監(jian)管科(ke)學(xue)研(yan)究渠道，探索開展中藥(yao)(yao)監(jian)管科(ke)學(xue)和(he)真實(shi)世界(jie)數(shu)據研(yan)究與應(ying)用(yong)。發揮國(guo)家藥(yao)(yao)監(jian)局(ju)中藥(yao)(yao)材及(ji)飲片質量(liang)控制(zhi)重點(dian)實(shi)驗室的(de)(de)(de)作用(yong)，開展基(ji)礎(chu)性、關鍵性、前瞻性和(he)戰略性監(jian)管技(ji)(ji)術研(yan)究，為(wei)中藥(yao)(yao)監(jian)管和(he)新藥(yao)(yao)研(yan)發，提供強有力的(de)(de)(de)技(ji)(ji)術支撐。

4、支(zhi)持(chi)產(chan)業(ye)升級和對(dui)外交流。推(tui)進中藥(yao)生產(chan)企業(ye)高(gao)端化(hua)、智能化(hua)、綠色化(hua)建設，加強技術集成(cheng)和工藝創新，提升中藥(yao)裝備制(zhi)造(zao)水平(ping)，加速(su)中藥(yao)生產(chan)工藝、流程的(de)(de)標(biao)準(zhun)化(hua)、現代化(hua)。借助“一(yi)帶一(yi)路”發(fa)展(zhan)戰(zhan)略，支(zhi)持(chi)現代中藥(yao)企業(ye)與國外高(gao)等院校、科研(yan)機構、醫藥(yao)企業(ye)等開(kai)展(zhan)合(he)作交流，推(tui)動中藥(yao)產(chan)品在海外注冊，不斷(duan)擴大隴藥(yao)在國內外的(de)(de)品牌影響(xiang)力。