各省、自(zi)治區(qu)、直轄市藥品監(jian)(jian)督管理局，新疆生產建(jian)設兵團藥品監(jian)(jian)督管理局，局機關(guan)各司(si)局，各直屬單(dan)位(wei)：

  中(zhong)藥(yao)(yao)是中(zhong)華民族(zu)的(de)瑰(gui)寶，為(wei)造(zao)福(fu)人民健康作(zuo)(zuo)出(chu)巨大貢(gong)獻，特(te)別(bie)(bie)是新(xin)冠(guan)肺炎疫情爆發以來(lai)，中(zhong)藥(yao)(yao)彰顯特(te)色優勢，為(wei)打(da)贏疫情防控(kong)阻擊戰發揮(hui)了(le)重(zhong)要(yao)作(zuo)(zuo)用。黨中(zhong)央國務(wu)院(yuan)高度重(zhong)視中(zhong)醫藥(yao)(yao)工(gong)作(zuo)(zuo)，特(te)別(bie)(bie)是黨的(de)十八(ba)大以來(lai)，習近平總(zong)(zong)書記(ji)(ji)多次作(zuo)(zuo)出(chu)重(zhong)要(yao)指(zhi)(zhi)示(shi)批(pi)示(shi)，要(yao)求改革完善中(zhong)藥(yao)(yao)審評審批(pi)機制，為(wei)新(xin)時代中(zhong)藥(yao)(yao)傳(chuan)承(cheng)創新(xin)發展指(zhi)(zhi)明(ming)了(le)方向、提(ti)供了(le)遵(zun)循。為(wei)進一步貫徹習近平總(zong)(zong)書記(ji)(ji)系列(lie)重(zhong)要(yao)指(zhi)(zhi)示(shi)批(pi)示(shi)精(jing)神(shen)，深入落實中(zhong)共中(zhong)央、國務(wu)院(yuan)《關于促(cu)進中(zhong)醫藥(yao)(yao)傳(chuan)承(cheng)創新(xin)發展的(de)意見》決(jue)策部署(shu)，結合(he)藥(yao)(yao)品(pin)監管工(gong)作(zuo)(zuo)實際(ji)，提(ti)出(chu)以下(xia)意見。

  一、指導(dao)思想

  以(yi)習近平新時代中(zhong)(zhong)(zhong)(zhong)(zhong)國特色社會主義思(si)(si)想為指(zhi)導，全(quan)(quan)面(mian)貫徹黨的(de)(de)十九大和十九屆二中(zhong)(zhong)(zhong)(zhong)(zhong)、三中(zhong)(zhong)(zhong)(zhong)(zhong)、四(si)中(zhong)(zhong)(zhong)(zhong)(zhong)、五中(zhong)(zhong)(zhong)(zhong)(zhong)全(quan)(quan)會精(jing)神，堅持以(yi)人民為中(zhong)(zhong)(zhong)(zhong)(zhong)心的(de)(de)發展思(si)(si)想，全(quan)(quan)面(mian)落(luo)實“四(si)個(ge)最嚴(yan)”的(de)(de)要求，促進中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)傳(chuan)承創新發展。深化(hua)改革，健(jian)全(quan)(quan)符合中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)特點的(de)(de)審評審批體(ti)(ti)系(xi)。傳(chuan)承精(jing)華，注重(zhong)整體(ti)(ti)觀(guan)和中(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)原創思(si)(si)維，促進中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)守(shou)(shou)正(zheng)創新。堅守(shou)(shou)底線，強化(hua)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)質量安全(quan)(quan)監管。創新發展，推進中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)監管體(ti)(ti)系(xi)和監管能力現代化(hua)。

  二、促(cu)進(jin)中藥守正創新(xin)

  （一）堅持(chi)以臨(lin)床(chuang)(chuang)價(jia)值(zhi)為(wei)導(dao)向。重視(shi)根(gen)據(ju)中(zhong)(zhong)醫藥(yao)(yao)臨(lin)床(chuang)(chuang)治(zhi)療特點和實際評估(gu)臨(lin)床(chuang)(chuang)價(jia)值(zhi)，注重滿足尚未(wei)滿足的(de)臨(lin)床(chuang)(chuang)需(xu)求，制定(ding)中(zhong)(zhong)藥(yao)(yao)新藥(yao)(yao)臨(lin)床(chuang)(chuang)價(jia)值(zhi)評估(gu)技(ji)術指導(dao)原則。建立與中(zhong)(zhong)藥(yao)(yao)臨(lin)床(chuang)(chuang)定(ding)位(wei)相適應、體現(xian)其作用特點和優勢(shi)的(de)療效(xiao)評價(jia)標準。鼓勵開展以患者(zhe)為(wei)中(zhong)(zhong)心的(de)療效(xiao)評價(jia)。探(tan)索引(yin)入真(zhen)實世界證據(ju)用于支持(chi)中(zhong)(zhong)藥(yao)(yao)新藥(yao)(yao)注冊(ce)上(shang)市。

  （二）推(tui)動(dong)古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)中(zhong)藥復(fu)方(fang)(fang)制(zhi)(zhi)劑研制(zhi)(zhi)。明(ming)確(que)古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)中(zhong)藥復(fu)方(fang)(fang)制(zhi)(zhi)劑研制(zhi)(zhi)有關(guan)技術(shu)要求，促進古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)中(zhong)藥復(fu)方(fang)(fang)制(zhi)(zhi)劑研發(fa)，推(tui)進古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)向新(xin)藥轉化。會同(tong)國務院中(zhong)醫(yi)藥主(zhu)管部門(men)，建立(li)(li)溝通(tong)協調機制(zhi)(zhi)，組織研究、制(zhi)(zhi)定(ding)古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)關(guan)鍵信(xin)息(xi)考證意(yi)見。建立(li)(li)與(yu)古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)中(zhong)藥復(fu)方(fang)(fang)制(zhi)(zhi)劑特點相適應的審(shen)評模式，成立(li)(li)古(gu)代(dai)(dai)(dai)經典(dian)名(ming)(ming)(ming)方(fang)(fang)中(zhong)藥復(fu)方(fang)(fang)制(zhi)(zhi)劑專家審(shen)評委員(yuan)會，實施簡化審(shen)批。

  （三）促進中(zhong)藥(yao)創(chuang)新(xin)(xin)發展。探索引入新(xin)(xin)工具、新(xin)(xin)方法、新(xin)(xin)技術、新(xin)(xin)標準用于中(zhong)藥(yao)療(liao)效評價(jia)。推動開(kai)展多區域臨(lin)床試(shi)驗規范性研(yan)究能力與體(ti)系建設，促進中(zhong)藥(yao)臨(lin)床研(yan)究質量整體(ti)提升。發揮醫(yi)療(liao)機構中(zhong)藥(yao)制(zhi)(zhi)劑傳承創(chuang)新(xin)(xin)發展“孵化(hua)器(qi)”作用，鼓勵醫(yi)療(liao)機構制(zhi)(zhi)劑向中(zhong)藥(yao)新(xin)(xin)藥(yao)轉化(hua)。支(zhi)持以(yi)病證(zheng)結合、專病專藥(yao)或證(zheng)候類中(zhong)藥(yao)等多種(zhong)方式開(kai)展中(zhong)藥(yao)新(xin)(xin)藥(yao)研(yan)制(zhi)(zhi)。

  （四）鼓勵二次開發。制定中(zhong)藥(yao)(yao)(yao)改良(liang)型(xing)新藥(yao)(yao)(yao)研究相關技(ji)術要(yao)求，支(zhi)持運用(yong)符(fu)合(he)產品特(te)點的新技(ji)術、新工藝以及(ji)體現(xian)臨床(chuang)應(ying)用(yong)優勢和特(te)點的新劑型(xing)改進已(yi)上(shang)(shang)市中(zhong)藥(yao)(yao)(yao)品種(zhong)。支(zhi)持同名同方藥(yao)(yao)(yao)的研制，促進已(yi)上(shang)(shang)市中(zhong)藥(yao)(yao)(yao)同品種(zhong)的質量競爭。優化已(yi)上(shang)(shang)市中(zhong)藥(yao)(yao)(yao)變更(geng)相關技(ji)術要(yao)求。

  （五(wu)）加強中(zhong)藥(yao)(yao)(yao)(yao)(yao)安(an)全(quan)性研究(jiu)。引導藥(yao)(yao)(yao)(yao)(yao)品上(shang)市(shi)許(xu)可持有人(ren)(ren)主(zhu)動開(kai)展中(zhong)藥(yao)(yao)(yao)(yao)(yao)上(shang)市(shi)后(hou)研究(jiu)和上(shang)市(shi)后(hou)評(ping)價(jia)。建(jian)立(li)符合(he)中(zhong)藥(yao)(yao)(yao)(yao)(yao)特點的(de)(de)安(an)全(quan)性評(ping)價(jia)方法和標準體系，建(jian)立(li)以中(zhong)醫臨床為導向的(de)(de)中(zhong)藥(yao)(yao)(yao)(yao)(yao)安(an)全(quan)性分類分級評(ping)價(jia)策略。加大對來源(yuan)于古代經典名方、名老中(zhong)醫驗(yan)方、醫療(liao)機構(gou)制(zhi)劑等(deng)具(ju)有人(ren)(ren)用(yong)經驗(yan)的(de)(de)中(zhong)藥(yao)(yao)(yao)(yao)(yao)新藥(yao)(yao)(yao)(yao)(yao)安(an)全(quan)性評(ping)價(jia)技術標準的(de)(de)研究(jiu)。根據藥(yao)(yao)(yao)(yao)(yao)物組(zu)方、人(ren)(ren)用(yong)經驗(yan)、制(zhi)備工藝、用(yong)法用(yong)量、功能主(zhu)治特點等(deng)，在臨床試驗(yan)期間或上(shang)市(shi)后(hou)，開(kai)展各階段相應(ying)的(de)(de)非臨床和臨床安(an)全(quan)性研究(jiu)。

  三、健全符合中藥特(te)點的審評審批體系

  （六）改(gai)革中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注(zhu)冊分類。尊重中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)特(te)點，遵循中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)研制(zhi)規律，將“安全(quan)、有效、質量可控”的(de)(de)藥(yao)(yao)(yao)品(pin)基本要(yao)求與中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)傳承(cheng)創新發展(zhan)獨特(te)的(de)(de)理論體系和實踐特(te)點有機結合。根據(ju)(ju)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注(zhu)冊產品(pin)特(te)性、創新程度和研制(zhi)實踐情況，改(gai)革中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注(zhu)冊分類，不再僅(jin)以物質基礎作為劃分注(zhu)冊類別的(de)(de)依據(ju)(ju)，開辟具有中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)特(te)色(se)的(de)(de)注(zhu)冊申報路徑。

  （七(qi)）構建(jian)“三(san)結合(he)”審評證據體(ti)系。進(jin)一步重視(shi)人用(yong)經(jing)驗(yan)對(dui)中藥(yao)安全性(xing)、有效性(xing)的支持作用(yong)，按(an)照中藥(yao)特點(dian)、研發規律和實際(ji)，構建(jian)中醫藥(yao)理論、人用(yong)經(jing)驗(yan)和臨床試驗(yan)相結合(he)的審評證據體(ti)系。加強(qiang)對(dui)人用(yong)經(jing)驗(yan)的規范收集整理，規范申報(bao)資料要求。

  （八(ba)）改(gai)革完善中(zhong)(zhong)藥(yao)(yao)(yao)(yao)審(shen)評審(shen)批制度(du)。對臨(lin)(lin)(lin)床(chuang)(chuang)定位清晰且(qie)具(ju)有(you)明(ming)顯臨(lin)(lin)(lin)床(chuang)(chuang)價(jia)值，用(yong)于重大(da)疾病(bing)、罕見病(bing)防治(zhi)、臨(lin)(lin)(lin)床(chuang)(chuang)急需而市(shi)場短缺、或屬于兒童用(yong)藥(yao)(yao)(yao)(yao)的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)新(xin)藥(yao)(yao)(yao)(yao)申請實(shi)行優先審(shen)評審(shen)批。對治(zhi)療嚴重危及(ji)生命(ming)且(qie)尚無(wu)有(you)效治(zhi)療手段的(de)疾病(bing)以(yi)及(ji)國務院衛(wei)生健康(kang)或中(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)主管部門認定為急需的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)，藥(yao)(yao)(yao)(yao)物臨(lin)(lin)(lin)床(chuang)(chuang)試驗(yan)已有(you)數據或高質量(liang)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)人(ren)用(yong)經驗(yan)證據顯示療效并能預測(ce)其臨(lin)(lin)(lin)床(chuang)(chuang)價(jia)值的(de)，可以(yi)附條件批準(zhun)。對突發重大(da)公共衛(wei)生事(shi)件中(zhong)(zhong)應(ying)急所(suo)需的(de)已上市(shi)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)增加(jia)功能主治(zhi)實(shi)施特別審(shen)批。

  四、強化中藥質量安全監(jian)管

  （九(jiu)）加(jia)(jia)強(qiang)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)質量源(yuan)(yuan)頭(tou)管理(li)(li)。修訂(ding)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)生產質量管理(li)(li)規(gui)范(fan)（GAP），制定(ding)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)生產質量管理(li)(li)規(gui)范(fan)實施(shi)指南，引(yin)導促(cu)進中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)規(gui)范(fan)化種植(zhi)養殖，推動(dong)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)產地加(jia)(jia)工，鼓勵(li)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片(pian)企業將質量保障體系(xi)向種植(zhi)加(jia)(jia)工環(huan)節(jie)延伸，從源(yuan)(yuan)頭(tou)加(jia)(jia)強(qiang)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片(pian)質量控(kong)制。加(jia)(jia)強(qiang)和規(gui)范(fan)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)用中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)、中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片(pian)的質量管理(li)(li)，明(ming)確質量控(kong)制研究相關(guan)技術要求。保護野(ye)生藥(yao)(yao)材(cai)(cai)(cai)(cai)資(zi)(zi)源(yuan)(yuan)，嚴格限定(ding)使用瀕(bin)危(wei)野(ye)生動(dong)、植(zhi)物藥(yao)(yao)材(cai)(cai)(cai)(cai)。加(jia)(jia)強(qiang)開(kai)展中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)資(zi)(zi)源(yuan)(yuan)評估，保障中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)(cai)來源(yuan)(yuan)穩定(ding)和資(zi)(zi)源(yuan)(yuan)可(ke)持續利用。

  （十）加強(qiang)生產全過程的(de)質量(liang)(liang)控(kong)制(zhi)(zhi)。加大飛(fei)行檢查力度，嚴格執行藥(yao)品(pin)生產質量(liang)(liang)管理規范（GMP）。在(zai)傳承(cheng)中藥(yao)飲片(pian)(pian)(pian)傳統炮(pao)制(zhi)(zhi)方法和經驗基礎上，修訂藥(yao)品(pin)生產質量(liang)(liang)管理規范中藥(yao)飲片(pian)(pian)(pian)附錄。持續修訂完善包括(kuo)中藥(yao)材、中藥(yao)飲片(pian)(pian)(pian)、中間產品(pin)和制(zhi)(zhi)劑等在(zai)內的(de)完整的(de)內控(kong)質量(liang)(liang)標(biao)準(zhun)體系(xi)，保持藥(yao)品(pin)批間質量(liang)(liang)穩定可控(kong)。推動(dong)中藥(yao)制(zhi)(zhi)藥(yao)技(ji)術升(sheng)級(ji)，鼓勵生產企業逐步實現智能制(zhi)(zhi)造(zao)。

  （十一）加強(qiang)上市(shi)后監管(guan)。組織中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)專項檢(jian)查(cha)，持續(xu)加大(da)中(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)和中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)抽檢(jian)力度，持續(xu)排查(cha)化解風(feng)(feng)險隱(yin)患，依法(fa)(fa)(fa)處(chu)置違法(fa)(fa)(fa)違規(gui)(gui)企(qi)業(ye)。聚焦摻雜使假(jia)、染色增(zeng)重(zhong)、非(fei)法(fa)(fa)(fa)添(tian)加、非(fei)法(fa)(fa)(fa)渠道購(gou)入中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)等(deng)問題，開展中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)質(zhi)量集中(zhong)(zhong)(zhong)(zhong)(zhong)整(zheng)治，嚴厲打(da)擊(ji)(ji)違法(fa)(fa)(fa)違規(gui)(gui)行為。推(tui)(tui)動(dong)地方政府落實(shi)(shi)地方監管(guan)責任，加強(qiang)對中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材交易市(shi)場的(de)監管(guan)，嚴厲打(da)擊(ji)(ji)無證銷(xiao)售(shou)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)行為，持續(xu)凈(jing)化市(shi)場秩序。基(ji)于中(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)發(fa)(fa)展實(shi)(shi)際，研究完(wan)善按(an)照(zhao)省級(ji)飲(yin)片(pian)炮制規(gui)(gui)范(fan)生產中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)的(de)流通(tong)政策。強(qiang)化中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)不良反(fan)應監測(ce)，對監測(ce)中(zhong)(zhong)(zhong)(zhong)(zhong)發(fa)(fa)現的(de)風(feng)(feng)險信號及時組織評估并采取(qu)風(feng)(feng)險控制措(cuo)施。加強(qiang)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)說明(ming)書和標簽管(guan)理，推(tui)(tui)進(jin)對已(yi)上市(shi)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)說明(ming)書中(zhong)(zhong)(zhong)(zhong)(zhong)【禁忌】【不良反(fan)應】【注(zhu)意事項】等(deng)相關內容(rong)的(de)修改完(wan)善。

  （十二）加大保護(hu)(hu)中(zhong)(zhong)藥(yao)品(pin)(pin)種力度。修訂(ding)《中(zhong)(zhong)藥(yao)品(pin)(pin)種保護(hu)(hu)條(tiao)例》，將中(zhong)(zhong)藥(yao)品(pin)(pin)種保護(hu)(hu)制度與專(zhuan)利保護(hu)(hu)制度有機銜接，并納入中(zhong)(zhong)藥(yao)全生(sheng)命周(zhou)期(qi)注(zhu)冊管(guan)理之(zhi)中(zhong)(zhong)，發揮其對中(zhong)(zhong)藥(yao)創新藥(yao)、中(zhong)(zhong)藥(yao)改良型新藥(yao)以及古代經(jing)典名方(fang)中(zhong)(zhong)藥(yao)復方(fang)制劑等中(zhong)(zhong)藥(yao)品(pin)(pin)種的(de)保護(hu)(hu)作用。支持藥(yao)品(pin)(pin)上市許可持有人或申(shen)請人按有關(guan)規定(ding)進行相關(guan)專(zhuan)利信息的(de)登記、聲明。

  五、注重多方協調聯動

  （十(shi)三）加強(qiang)橫(heng)向(xiang)聯(lian)系。積極(ji)按(an)照(zhao)國務院(yuan)中醫藥工(gong)作(zuo)部際聯(lian)席會議部署，加強(qiang)與科(ke)技(ji)、衛生健康、中醫藥、醫保等部門的溝通協調，形成部門工(gong)作(zuo)合力，推進(jin)國家重大(da)科(ke)技(ji)項(xiang)目的成果轉化，滿足臨床需求，積極(ji)服務中藥產業高質量發展。

  （十四(si)(si)）督(du)促(cu)落實各方責(ze)任(ren)(ren)。壓實企業主體責(ze)任(ren)(ren)，督(du)促(cu)企業牢固(gu)樹(shu)立質量安(an)全第一(yi)責(ze)任(ren)(ren)人意識，履(lv)行藥品全生命周期管理責(ze)任(ren)(ren)，推進(jin)中藥企業誠信體系建設。全面落實“四(si)(si)個最嚴(yan)”的要求，切實承擔起藥品監管責(ze)任(ren)(ren)，牢牢守住(zhu)藥品安(an)全底線。推動(dong)地方黨委政府扛(kang)起藥品安(an)全政治責(ze)任(ren)(ren)，強化屬地管理責(ze)任(ren)(ren)。

  （十五）營(ying)造良(liang)好社(she)(she)會(hui)氛圍。加(jia)大中藥(yao)審評(ping)審批改(gai)革宣傳力度，加(jia)強重要(yao)政策(ce)、重大措施解讀，及(ji)時回(hui)應社(she)(she)會(hui)關(guan)切，合理引導各方預期，推動形(xing)成(cheng)全(quan)社(she)(she)會(hui)共同參(can)與中藥(yao)傳承創新的新格局(ju)。

  六、推進中藥監(jian)管(guan)體系和監(jian)管(guan)能力現(xian)代化

  （十(shi)六）完(wan)善中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)法規(gui)(gui)(gui)標(biao)(biao)準(zhun)體(ti)系(xi)(xi)。加快《藥(yao)(yao)品(pin)管理法》《中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)法》相(xiang)關配套規(gui)(gui)(gui)章制(zhi)(zhi)(zhi)度建設，健(jian)全完(wan)善中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)全生命(ming)周期監(jian)管制(zhi)(zhi)(zhi)度體(ti)系(xi)(xi)。加強(qiang)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)準(zhun)管理，優化國(guo)(guo)家(jia)藥(yao)(yao)品(pin)標(biao)(biao)準(zhun)形成機制(zhi)(zhi)(zhi)，持續完(wan)善以(yi)《中(zhong)(zhong)(zhong)(zhong)國(guo)(guo)藥(yao)(yao)典》為(wei)(wei)核心的(de)國(guo)(guo)家(jia)藥(yao)(yao)品(pin)標(biao)(biao)準(zhun)體(ti)系(xi)(xi)。建立(li)和(he)完(wan)善以(yi)臨床為(wei)(wei)導向、符(fu)合中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)特點(dian)的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)質量(liang)標(biao)(biao)準(zhun)、技(ji)術規(gui)(gui)(gui)范和(he)評(ping)價體(ti)系(xi)(xi)，全面(mian)客觀反映中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)質量(liang)。研究完(wan)善中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材中(zhong)(zhong)(zhong)(zhong)農藥(yao)(yao)殘留、重金屬與(yu)有害(hai)元素(su)、真(zhen)菌毒素(su)等有害(hai)物質限量(liang)要求和(he)檢測方法。制(zhi)(zhi)(zhi)定實(shi)施全國(guo)(guo)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲片炮制(zhi)(zhi)(zhi)規(gui)(gui)(gui)范。加強(qiang)地方藥(yao)(yao)材標(biao)(biao)準(zhun)和(he)省級飲片炮制(zhi)(zhi)(zhi)規(gui)(gui)(gui)范的(de)監(jian)督實(shi)施。

  （十七）強化(hua)技術(shu)支(zhi)撐體系(xi)(xi)建設(she)(she)。以編制“十四(si)五(wu)”藥(yao)品安全(quan)及高(gao)質量發展(zhan)規劃(hua)為契機(ji)，開展(zhan)重(zhong)點課題研究，加(jia)(jia)強檢驗(yan)檢測(ce)、審(shen)評(ping)(ping)審(shen)批、審(shen)核查驗(yan)、監測(ce)評(ping)(ping)價等重(zhong)點技術(shu)支(zhi)撐機(ji)構(gou)建設(she)(she)。加(jia)(jia)強“智慧監管”建設(she)(she)，創新利用大數據、互(hu)聯(lian)網、云計(ji)算等現代(dai)信(xin)息技術(shu)，推(tui)進(jin)(jin)藥(yao)品追溯信(xin)息互(hu)通互(hu)享。推(tui)動相關(guan)部門共(gong)同開展(zhan)中藥(yao)材信(xin)息化(hua)追溯體系(xi)(xi)建設(she)(she)，進(jin)(jin)一(yi)步(bu)提高(gao)中藥(yao)材質量安全(quan)保(bao)障水平。穩步(bu)推(tui)進(jin)(jin)中藥(yao)生(sheng)產企業建立藥(yao)品追溯體系(xi)(xi)，對(dui)中藥(yao)產品賦碼、掃碼，逐步(bu)在藥(yao)品生(sheng)產流通全(quan)過程實現可追溯。

  （十八）加強(qiang)(qiang)中(zhong)藥(yao)監(jian)(jian)管(guan)科學(xue)研究(jiu)。鼓勵(li)運用現代科學(xue)技術(shu)和傳統中(zhong)醫藥(yao)研究(jiu)方(fang)(fang)法(fa)，深入開展中(zhong)藥(yao)監(jian)(jian)管(guan)科學(xue)研究(jiu)，積極推動中(zhong)藥(yao)監(jian)(jian)管(guan)理(li)念(nian)、制度(du)、機(ji)制創新(xin)，強(qiang)(qiang)化(hua)成(cheng)果(guo)轉(zhuan)化(hua)應用，推出一批中(zhong)藥(yao)監(jian)(jian)管(guan)新(xin)工具、新(xin)方(fang)(fang)法(fa)和新(xin)標準。深化(hua)與國內一流大學(xue)、科研機(ji)構之間合作(zuo)，建立中(zhong)藥(yao)監(jian)(jian)管(guan)科學(xue)合作(zuo)研究(jiu)基地(di)和國家藥(yao)監(jian)(jian)局重點實驗室，強(qiang)(qiang)化(hua)中(zhong)藥(yao)監(jian)(jian)管(guan)基礎性、戰略性問題研究(jiu)。

  （十九）加強(qiang)監管隊伍建設。加快(kuai)職業(ye)化、專業(ye)化的中藥審評(ping)(ping)員(yuan)、檢查員(yuan)隊伍建設，完善(shan)分級分類管理(li)制度，明確崗位準入和(he)任職條件。科學合理(li)開展中藥專業(ye)人員(yuan)的考核評(ping)(ping)價和(he)職級升(sheng)降，擴寬職業(ye)發展空(kong)間，完善(shan)薪(xin)酬待遇保(bao)障機制，確保(bao)高層次人才“招得來、留得住”。

  （二十）積極推(tui)動國(guo)際(ji)傳統藥監管(guan)(guan)合(he)(he)作。深化(hua)(hua)與世界衛生(sheng)組(zu)織(zhi)（WHO）合(he)(he)作，積極開展與國(guo)際(ji)草(cao)藥監管(guan)(guan)合(he)(he)作組(zu)織(zhi)（IRCH）、西太區草(cao)藥監管(guan)(guan)協(xie)調(diao)(diao)論壇（FHH）等傳統藥監管(guan)(guan)國(guo)際(ji)組(zu)織(zhi)以及有關國(guo)家(jia)或地區藥品監管(guan)(guan)、藥典機構的交(jiao)流(liu)，深入參與國(guo)際(ji)傳統藥相關政策規則制(zhi)定(ding)、標準協(xie)調(diao)(diao)，推(tui)動中(zhong)(zhong)藥標準國(guo)際(ji)化(hua)(hua)。持續(xu)提升(sheng)我國(guo)中(zhong)(zhong)藥監管(guan)(guan)在國(guo)際(ji)監管(guan)(guan)組(zu)織(zhi)中(zhong)(zhong)的話語權(quan)，推(tui)動中(zhong)(zhong)醫藥更(geng)好地為全世界人民服務。




國家藥(yao)監局

   2020年(nian)12月21日 日