各省、自治區、直(zhi)轄市(shi)和新(xin)疆生產(chan)建(jian)設(she)兵團藥品監督管理局(ju)，局(ju)機關(guan)各司局(ju)，各直(zhi)屬單位：

  《關于進一(yi)步加(jia)強中藥(yao)科學監管  促進中藥(yao)傳承創(chuang)新發展(zhan)的若干措施》已經局長辦(ban)公會同意(yi)，現印發給(gei)你們(men)，請認真貫(guan)徹(che)執行。

  國(guo)家藥監局

  2023年1月3日

關于進(jin)(jin)一步加強中(zhong)藥科學監管(guan)促進(jin)(jin)中(zhong)藥傳承創(chuang)新發展的若干措(cuo)施

  為深入貫徹黨的(de)二十(shi)大(da)精(jing)神(shen)，全(quan)(quan)面(mian)(mian)落實(shi)(shi)二十(shi)大(da)報(bao)告(gao)關于“強化食品藥(yao)(yao)品安全(quan)(quan)監(jian)(jian)管”“促進(jin)中(zhong)(zhong)(zhong)醫藥(yao)(yao)傳承創新(xin)(xin)發(fa)展”的(de)重(zhong)大(da)戰略部署，堅持以(yi)習近平(ping)新(xin)(xin)時代中(zhong)(zhong)(zhong)國特色社會主義思想為指導，準確把握(wo)當前(qian)中(zhong)(zhong)(zhong)藥(yao)(yao)質(zhi)量安全(quan)(quan)監(jian)(jian)管和(he)中(zhong)(zhong)(zhong)藥(yao)(yao)產(chan)業(ye)高(gao)質(zhi)量發(fa)展面(mian)(mian)臨的(de)新(xin)(xin)形勢、新(xin)(xin)任務和(he)新(xin)(xin)挑戰，全(quan)(quan)面(mian)(mian)加(jia)強中(zhong)(zhong)(zhong)藥(yao)(yao)全(quan)(quan)產(chan)業(ye)鏈質(zhi)量管理、全(quan)(quan)過程審評審批加(jia)速、全(quan)(quan)生命周期(qi)產(chan)品服務、全(quan)(quan)球化監(jian)(jian)管合作、全(quan)(quan)方(fang)位監(jian)(jian)管科學創新(xin)(xin)，向(xiang)縱深推進(jin)中(zhong)(zhong)(zhong)國式現(xian)代化藥(yao)(yao)品監(jian)(jian)管實(shi)(shi)踐和(he)具有中(zhong)(zhong)(zhong)國特色的(de)中(zhong)(zhong)(zhong)藥(yao)(yao)科學監(jian)(jian)管體系(xi)建設，特制(zhi)定以(yi)下若干措施。

  一、加強中藥材質量管(guan)理

  （一）規范(fan)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)產地加工。進(jin)一步調動(dong)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)產地地方政(zheng)府、中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)生產企(qi)(qi)業、基地農戶積極性，推動(dong)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)生產企(qi)(qi)業將藥(yao)(yao)品質量管理(li)體(ti)系向中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)種植加工環(huan)節(jie)延(yan)伸(shen)，促進(jin)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)生產加工與生態文明建設和鄉村振興結合。省級藥(yao)(yao)品監督管理(li)部(bu)門要加強中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)飲(yin)片(pian)生產企(qi)(qi)業采購產地加工（趁鮮切制）中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)監管，在符合《中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)生產質量管理(li)規范(fan)》（GAP）的基礎(chu)上，規范(fan)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)產地加工及采購行為，加強趁鮮切制中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)材(cai)(cai)(cai)質量管理(li)。

  （二）推(tui)進實施《中(zhong)(zhong)藥(yao)(yao)材生產(chan)(chan)質量管理規范》（GAP）。充分(fen)發揮GAP在(zai)中(zhong)(zhong)藥(yao)(yao)材生產(chan)(chan)質量監管的(de)(de)重要(yao)作(zuo)用(yong)(yong)，組建(jian)國(guo)家GAP專(zhuan)家工作(zuo)組，研究(jiu)完善實施工作(zuo)推(tui)進方案和(he)配(pei)套技術要(yao)求，促進中(zhong)(zhong)藥(yao)(yao)材規范化(hua)(hua)、產(chan)(chan)業(ye)化(hua)(hua)、規模化(hua)(hua)種(zhong)(zhong)植養(yang)殖(zhi)。通過GAP延伸檢(jian)查、符(fu)合性檢(jian)查和(he)日(ri)常監督檢(jian)查，推(tui)動中(zhong)(zhong)藥(yao)(yao)生產(chan)(chan)企業(ye)采(cai)取自建(jian)、共建(jian)、聯建(jian)或共享中(zhong)(zhong)藥(yao)(yao)材種(zhong)(zhong)植養(yang)殖(zhi)基地，穩定中(zhong)(zhong)藥(yao)(yao)材供給(gei)，使(shi)用(yong)(yong)符(fu)合GAP要(yao)求的(de)(de)中(zhong)(zhong)藥(yao)(yao)材。分(fen)品種(zhong)(zhong)、分(fen)步驟研究(jiu)明(ming)確(que)部分(fen)重點或高風(feng)險(xian)中(zhong)(zhong)藥(yao)(yao)品種(zhong)(zhong)生產(chan)(chan)使(shi)用(yong)(yong)的(de)(de)中(zhong)(zhong)藥(yao)(yao)材應當符(fu)合GAP要(yao)求。中(zhong)(zhong)藥(yao)(yao)注射劑生產(chan)(chan)所用(yong)(yong)的(de)(de)中(zhong)(zhong)藥(yao)(yao)材,原則上應當符(fu)合GAP要(yao)求。

  （三）完善中(zhong)藥(yao)(yao)材(cai)注(zhu)冊管(guan)(guan)理。會同(tong)國家(jia)中(zhong)醫藥(yao)(yao)管(guan)(guan)理局制定《實施(shi)(shi)審批(pi)管(guan)(guan)理的(de)中(zhong)藥(yao)(yao)材(cai)品(pin)種目(mu)錄(lu)》，依法對(dui)(dui)符合規(gui)定情形的(de)中(zhong)藥(yao)(yao)材(cai)品(pin)種實施(shi)(shi)審批(pi)管(guan)(guan)理。加強(qiang)對(dui)(dui)地(di)區性民(min)間習用(yong)藥(yao)(yao)材(cai)管(guan)(guan)理，修(xiu)訂《地(di)區性民(min)間習用(yong)藥(yao)(yao)材(cai)管(guan)(guan)理辦法》，指導省級藥(yao)(yao)品(pin)監(jian)督管(guan)(guan)理部門制修(xiu)訂地(di)區性民(min)間習用(yong)藥(yao)(yao)材(cai)標準(zhun)(zhun)，確保地(di)方藥(yao)(yao)材(cai)標準(zhun)(zhun)與國家(jia)藥(yao)(yao)品(pin)標準(zhun)(zhun)協調統一。

  （四）建立中(zhong)藥材(cai)(cai)(cai)(cai)質量(liang)(liang)監(jian)測(ce)工(gong)作(zuo)機制。組織綜合分析中(zhong)藥材(cai)(cai)(cai)(cai)質量(liang)(liang)監(jian)測(ce)數(shu)(shu)(shu)據(ju)，關注(zhu)不同產地(di)中(zhong)藥材(cai)(cai)(cai)(cai)質量(liang)(liang)的差異(yi)，研究(jiu)發布中(zhong)藥材(cai)(cai)(cai)(cai)質量(liang)(liang)監(jian)測(ce)報(bao)告。構建涵(han)蓋(gai)藥材(cai)(cai)(cai)(cai)品種考證、產地(di)、質量(liang)(liang)、安全等信息(xi)的國家中(zhong)藥材(cai)(cai)(cai)(cai)質量(liang)(liang)基本(ben)數(shu)(shu)(shu)據(ju)庫，促進中(zhong)藥材(cai)(cai)(cai)(cai)數(shu)(shu)(shu)據(ju)信息(xi)的共(gong)享和共(gong)用(yong)。

  （五）改進(jin)(jin)(jin)(jin)(jin)中藥材(cai)(cai)進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)管理。持(chi)續強(qiang)化進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)藥材(cai)(cai)檢(jian)驗能力建設，提升進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)藥材(cai)(cai)質量追(zhui)溯水平。根據國家戰(zhan)略區域(yu)規(gui)劃要求，有序開展對申請增(zeng)設允(yun)許(xu)(xu)藥品進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)的口(kou)(kou)(kou)(kou)岸(an)或允(yun)許(xu)(xu)藥材(cai)(cai)進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)的邊境口(kou)(kou)(kou)(kou)岸(an)現場考核評估工作，合(he)理增(zeng)設允(yun)許(xu)(xu)藥品進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)的口(kou)(kou)(kou)(kou)岸(an)或允(yun)許(xu)(xu)藥材(cai)(cai)進(jin)(jin)(jin)(jin)(jin)口(kou)(kou)(kou)(kou)的邊境口(kou)(kou)(kou)(kou)岸(an)。

  二(er)、強化(hua)中藥飲片、中藥配方(fang)顆粒監管

  （六）加強中(zhong)(zhong)藥(yao)(yao)飲片審批(pi)(pi)管理。遵循中(zhong)(zhong)醫(yi)(yi)藥(yao)(yao)理論和用藥(yao)(yao)規(gui)律，圍繞質量(liang)安全(quan)風險，推動中(zhong)(zhong)藥(yao)(yao)飲片炮制(zhi)機(ji)理研(yan)究，建立(li)健全(quan)中(zhong)(zhong)藥(yao)(yao)飲片質量(liang)評價體系。會同國家中(zhong)(zhong)醫(yi)(yi)藥(yao)(yao)管理局制(zhi)定(ding)《實施審批(pi)(pi)管理的中(zhong)(zhong)藥(yao)(yao)飲片目(mu)錄》及(ji)配套文(wen)件，依(yi)法對符(fu)合規(gui)定(ding)情(qing)形的中(zhong)(zhong)藥(yao)(yao)飲片實施審批(pi)(pi)管理。

  （七）完(wan)善(shan)(shan)(shan)中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范。分(fen)批發布實施(shi)并(bing)不斷(duan)提高完(wan)善(shan)(shan)(shan)《國家中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范》，加強對省級(ji)中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范的備案管理，指導省級(ji)中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范的制(zhi)(zhi)(zhi)(zhi)定(ding)(ding)和修(xiu)訂。強化省級(ji)中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范監督實施(shi)，完(wan)善(shan)(shan)(shan)按照省級(ji)中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片炮(pao)制(zhi)(zhi)(zhi)(zhi)規(gui)(gui)范生(sheng)產中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片的生(sheng)產、流(liu)通、使用管理等規(gui)(gui)定(ding)(ding)。

  （八）規(gui)(gui)范中(zhong)藥(yao)(yao)飲片(pian)(pian)生(sheng)產和(he)質量(liang)追(zhui)溯(su)。遵循(xun)中(zhong)藥(yao)(yao)飲片(pian)(pian)炮制特點，結合(he)傳統炮制方(fang)法和(he)現代生(sheng)產技術手段，研究(jiu)完善(shan)中(zhong)藥(yao)(yao)飲片(pian)(pian)生(sheng)產質量(liang)管理規(gui)(gui)范，探索建立中(zhong)藥(yao)(yao)飲片(pian)(pian)生(sheng)產流通追(zhui)溯(su)體系(xi)，逐(zhu)步實(shi)現重(zhong)點品種來(lai)源可查、去向可追(zhui)和(he)追(zhui)溯(su)信息互通互享(xiang)。發布(bu)實(shi)施(shi)《中(zhong)藥(yao)(yao)飲片(pian)(pian)包裝標(biao)簽(qian)管理規(gui)(gui)定（試行）》及(ji)相關配套(tao)技術文件，規(gui)(gui)范中(zhong)藥(yao)(yao)飲片(pian)(pian)標(biao)簽(qian)的標(biao)識內容。

  （九）推(tui)動改進(jin)中(zhong)藥(yao)飲片生產(chan)經營模(mo)式(shi)(shi)。引導和(he)督促(cu)中(zhong)藥(yao)飲片生產(chan)企業結(jie)合產(chan)業規劃、資源(yuan)優(you)勢、技(ji)術能力等生產(chan)實際，優(you)化(hua)(hua)調整(zheng)品(pin)種生產(chan)結(jie)構，逐步推(tui)進(jin)實現(xian)中(zhong)藥(yao)飲片集約化(hua)(hua)、精品(pin)化(hua)(hua)、規模(mo)化(hua)(hua)的生產(chan)模(mo)式(shi)(shi)。

  （十）強化中藥(yao)(yao)配(pei)(pei)方(fang)顆粒(li)生(sheng)(sheng)產過(guo)程管(guan)理(li)。督促中藥(yao)(yao)配(pei)(pei)方(fang)顆粒(li)生(sheng)(sheng)產企業嚴格按照備案的生(sheng)(sheng)產工藝生(sheng)(sheng)產，嚴格供應商審核，加強中藥(yao)(yao)材鑒別、中藥(yao)(yao)飲片炮制、顆粒(li)生(sheng)(sheng)產、檢驗放行等全(quan)環節質(zhi)量管(guan)理(li)，確保生(sheng)(sheng)產全(quan)過(guo)程符合相(xiang)應的藥(yao)(yao)品標準和藥(yao)(yao)品生(sheng)(sheng)產質(zhi)量管(guan)理(li)規范。

  三(san)、優化醫療機構中藥制劑管理

  （十一）積極發(fa)揮(hui)醫療(liao)(liao)(liao)機(ji)構(gou)中(zhong)(zhong)藥制(zhi)劑(ji)作(zuo)用(yong)(yong)(yong)。推動醫療(liao)(liao)(liao)機(ji)構(gou)采(cai)用(yong)(yong)(yong)大(da)數據、人工(gong)智能、真實世界研究等(deng)技術手段，圍繞臨(lin)床定位、適用(yong)(yong)(yong)人群(qun)、用(yong)(yong)(yong)法用(yong)(yong)(yong)量、療(liao)(liao)(liao)程以及體現(xian)中(zhong)(zhong)藥作(zuo)用(yong)(yong)(yong)特(te)點和優勢(shi)的評價(jia)指標等(deng)對醫療(liao)(liao)(liao)機(ji)構(gou)中(zhong)(zhong)藥制(zhi)劑(ji)開(kai)展研究。發(fa)揮(hui)人用(yong)(yong)(yong)經驗對醫療(liao)(liao)(liao)機(ji)構(gou)中(zhong)(zhong)藥制(zhi)劑(ji)的安(an)全性(xing)、有(you)效(xiao)性(xing)的支(zhi)持作(zuo)用(yong)(yong)(yong)，支(zhi)持將療(liao)(liao)(liao)效(xiao)確切(qie)、特(te)色(se)優勢(shi)明顯，不(bu)良反應少的醫療(liao)(liao)(liao)機(ji)構(gou)中(zhong)(zhong)藥制(zhi)劑(ji)品種向新(xin)藥轉(zhuan)化。

  （十二）嚴(yan)格(ge)備(bei)案(an)和(he)(he)調(diao)劑(ji)(ji)(ji)(ji)使(shi)用(yong)醫療(liao)(liao)機(ji)構(gou)(gou)中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)(ji)(ji)(ji)。嚴(yan)格(ge)按照(zhao)規定開展(zhan)(zhan)醫療(liao)(liao)機(ji)構(gou)(gou)應用(yong)傳(chuan)統工(gong)藝配制(zhi)中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)(ji)(ji)(ji)的備(bei)案(an)管(guan)理工(gong)作，及時(shi)對已備(bei)案(an)的醫療(liao)(liao)機(ji)構(gou)(gou)制(zhi)劑(ji)(ji)(ji)(ji)進行資料核查(cha)和(he)(he)現場檢(jian)查(cha)，必要時(shi)按照(zhao)相關規定開展(zhan)(zhan)抽樣檢(jian)驗。規范(fan)調(diao)劑(ji)(ji)(ji)(ji)使(shi)用(yong)醫療(liao)(liao)機(ji)構(gou)(gou)中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)(ji)(ji)(ji)，支(zhi)持通過(guo)調(diao)劑(ji)(ji)(ji)(ji)在不(bu)同醫療(liao)(liao)機(ji)構(gou)(gou)內(nei)開展(zhan)(zhan)多中(zhong)(zhong)心臨床研究。省級藥(yao)(yao)品監(jian)督管(guan)理部門參(can)照(zhao)《藥(yao)(yao)品生產質(zhi)量管(guan)理規范(fan)》等相關規定，規范(fan)和(he)(he)加強醫療(liao)(liao)機(ji)構(gou)(gou)中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)(ji)(ji)(ji)區(qu)域(yu)配制(zhi)車間監(jian)管(guan)，嚴(yan)格(ge)監(jian)管(guan)其配制(zhi)中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)(ji)(ji)(ji)的質(zhi)量。

  （十三）加(jia)強醫(yi)療(liao)(liao)機(ji)構中(zhong)(zhong)藥(yao)(yao)制劑不良反(fan)(fan)應(ying)(ying)監測。推動醫(yi)療(liao)(liao)機(ji)構建立和完善藥(yao)(yao)物警戒體系，主(zhu)(zhu)動開展(zhan)對醫(yi)療(liao)(liao)機(ji)構中(zhong)(zhong)藥(yao)(yao)制劑疑似不良反(fan)(fan)應(ying)(ying)的監測、識別、評估和控制，必要時對醫(yi)療(liao)(liao)機(ji)構中(zhong)(zhong)藥(yao)(yao)制劑的有(you)效性、安(an)全性開展(zhan)研(yan)究和綜合評價(jia)，對療(liao)(liao)效不確切、不良反(fan)(fan)應(ying)(ying)大或(huo)者其他原(yuan)因危害(hai)人體健康的，主(zhu)(zhu)動向所在地省(sheng)級藥(yao)(yao)品監督管理部門申(shen)請注銷有(you)關批準證明文件或(huo)注銷備(bei)案。

  四、完善中藥(yao)審評審批機制

  （十四(si)）持續推(tui)動中(zhong)藥(yao)(yao)評價(jia)體(ti)系的(de)研(yan)究和創新。優化(hua)中(zhong)藥(yao)(yao)審評審批體(ti)系和機制，推(tui)進(jin)注(zhu)冊“末(mo)端”加速(su)變為(wei)向(xiang)“前端”延伸(shen)的(de)全程(cheng)加速(su)，制定(ding)(ding)發布實施(shi)《中(zhong)藥(yao)(yao)注(zhu)冊管理(li)專(zhuan)門(men)規(gui)定(ding)(ding)》，加快推(tui)進(jin)中(zhong)醫藥(yao)(yao)理(li)論、人(ren)用經驗、臨(lin)床(chuang)試驗“三結(jie)合”審評證據(ju)體(ti)系建設，建立完善以臨(lin)床(chuang)價(jia)值(zhi)為(wei)導向(xiang)的(de)多元化(hua)中(zhong)藥(yao)(yao)評價(jia)技(ji)術(shu)標準和臨(lin)床(chuang)療效評價(jia)方法。

  （十五(wu)）完善中(zhong)藥應(ying)急(ji)審(shen)評審(shen)批機制(zhi)(zhi)。快速(su)有效(xiao)應(ying)對(dui)(dui)公共(gong)突發衛(wei)生事件，對(dui)(dui)國務(wu)院衛(wei)生健(jian)康或(huo)者中(zhong)醫藥管(guan)理部門認定急(ji)需中(zhong)藥實(shi)施特別(bie)審(shen)批程序。鼓勵并(bing)扶持用于(yu)重大疾(ji)病、罕見病，或(huo)者兒童用中(zhong)藥新藥的研制(zhi)(zhi)，對(dui)(dui)符合(he)規定情(qing)形(xing)的相(xiang)關注冊申請實(shi)行(xing)優先審(shen)評審(shen)批。

  （十六）完善中(zhong)(zhong)藥(yao)(yao)(yao)(yao)處方藥(yao)(yao)(yao)(yao)與非處方藥(yao)(yao)(yao)(yao)分類管理(li)。優化非處方藥(yao)(yao)(yao)(yao)上(shang)市注冊與上(shang)市后轉(zhuan)換(huan)相關技術(shu)指導原則體系和要求(qiu)，規(gui)范開展中(zhong)(zhong)藥(yao)(yao)(yao)(yao)處方藥(yao)(yao)(yao)(yao)轉(zhuan)換(huan)為非處方藥(yao)(yao)(yao)(yao)技術(shu)評(ping)價(jia)，研究制定中(zhong)(zhong)藥(yao)(yao)(yao)(yao)非處方藥(yao)(yao)(yao)(yao)審評(ping)技術(shu)要求(qiu)，進一步發揮(hui)中(zhong)(zhong)成藥(yao)(yao)(yao)(yao)在自(zi)我藥(yao)(yao)(yao)(yao)療中(zhong)(zhong)的作(zuo)用。

  五、重視中藥上市后管理(li)

  （十七）完(wan)善中藥(yao)上(shang)(shang)市(shi)(shi)后(hou)管理工作機制(zhi)。加強藥(yao)品全生命周期服務，督(du)促(cu)藥(yao)品上(shang)(shang)市(shi)(shi)許可(ke)持有人履行(xing)主(zhu)體責任和(he)義務，根據(ju)產(chan)品特點制(zhi)定(ding)上(shang)(shang)市(shi)(shi)后(hou)風險管理計(ji)劃，主(zhu)動開(kai)展(zhan)上(shang)(shang)市(shi)(shi)后(hou)研究(jiu)和(he)上(shang)(shang)市(shi)(shi)后(hou)評(ping)價(jia)，對藥(yao)品的獲益(yi)和(he)風險進行(xing)綜(zong)合分(fen)析評(ping)估(gu)。根據(ju)評(ping)估(gu)結果，依法采(cai)取修訂藥(yao)品說明書、暫停生產(chan)銷(xiao)售、召回藥(yao)品、主(zhu)動申請注銷(xiao)藥(yao)品批準證明文件(jian)等(deng)措施。督(du)促(cu)藥(yao)品上(shang)(shang)市(shi)(shi)許可(ke)持有人主(zhu)動開(kai)展(zhan)中藥(yao)注射劑(ji)上(shang)(shang)市(shi)(shi)后(hou)研究(jiu)和(he)評(ping)價(jia)，持續(xu)提升對中藥(yao)注射劑(ji)的藥(yao)物警戒水平和(he)能力。

  （十(shi)八）強化(hua)中(zhong)藥上市后變(bian)更管(guan)理。完(wan)善基于風險控(kong)制的上市后變(bian)更管(guan)理，進一步明確不同變(bian)更風險等級(ji)劃(hua)分的標(biao)準(zhun)，加強對高風險變(bian)更品種的審(shen)評審(shen)批。強化(hua)藥品上市許(xu)可(ke)持有(you)人(ren)主動提(ti)升(sheng)中(zhong)藥質量的主體(ti)責任意識，發揮(hui)末(mo)端政策(ce)發力優勢，提(ti)升(sheng)藥品上市許(xu)可(ke)持有(you)人(ren)對產品的全生命周期管(guan)理能力。

  （十九(jiu)）加強中藥(yao)不良反應監測(ce)。組(zu)織研究(jiu)開發(fa)符合中藥(yao)特點的中藥(yao)不良反應信號監測(ce)工(gong)具(ju)，對發(fa)現的安全(quan)性(xing)(xing)風(feng)險信號及(ji)時(shi)開展綜合分析研判，采取(qu)相應的風(feng)險控制(zhi)措施，加強對不良反應聚集性(xing)(xing)事件的監測(ce)和(he)處置力度，及(ji)時(shi)防控用(yong)藥(yao)風(feng)險。

  六、提升中藥(yao)標準管理水平(ping)

  （二十）優(you)化中藥(yao)(yao)標(biao)(biao)準(zhun)管(guan)理(li)。研究制(zhi)定中藥(yao)(yao)標(biao)(biao)準(zhun)管(guan)理(li)專門規定。以《中國(guo)藥(yao)(yao)典》（一部(bu)）修訂(ding)為契機(ji)，探索(suo)實施中藥(yao)(yao)國(guo)家標(biao)(biao)準(zhun)制(zhi)定質量管(guan)理(li)規范，及時將科(ke)學、成熟(shu)、適用的中藥(yao)(yao)相(xiang)關(guan)注冊標(biao)(biao)準(zhun)、國(guo)際標(biao)(biao)準(zhun)、團體(ti)標(biao)(biao)準(zhun)或企業內控標(biao)(biao)準(zhun)等轉化為國(guo)家標(biao)(biao)準(zhun)。建立中藥(yao)(yao)國(guo)家標(biao)(biao)準(zhun)快速修訂(ding)機(ji)制(zhi)和修訂(ding)程序(xu)。加強藥(yao)(yao)典委(wei)員(yuan)會(hui)(hui)中藥(yao)(yao)相(xiang)關(guan)專委(wei)會(hui)(hui)建設，完善委(wei)員(yuan)遴選和產(chan)生(sheng)機(ji)制(zhi)。

  （二(er)十一）科學完(wan)(wan)善(shan)中(zhong)藥(yao)(yao)(yao)標(biao)(biao)準。持續推進中(zhong)藥(yao)(yao)(yao)標(biao)(biao)準制定、修訂，加快國家中(zhong)藥(yao)(yao)(yao)飲片炮(pao)制規范(fan)、中(zhong)藥(yao)(yao)(yao)配(pei)方(fang)(fang)顆粒標(biao)(biao)準發布實施。合理設置中(zhong)藥(yao)(yao)(yao)中(zhong)農藥(yao)(yao)(yao)殘留、重金屬與(yu)有害元素(su)(su)、真菌毒素(su)(su)等(deng)有害物(wu)質以(yi)及植物(wu)生長(chang)調節劑等(deng)的限(xian)量要(yao)求和(he)(he)檢(jian)測(ce)方(fang)(fang)法。加強中(zhong)藥(yao)(yao)(yao)內源性有毒成(cheng)份檢(jian)測(ce)技術(shu)研究(jiu)和(he)(he)風險評估體系(xi)建設，制訂符合中(zhong)藥(yao)(yao)(yao)特(te)點的內源性有毒成(cheng)份限(xian)度標(biao)(biao)準和(he)(he)完(wan)(wan)善(shan)用(yong)法用(yong)量。

  （二十二）加(jia)強(qiang)中(zhong)藥(yao)標(biao)準物(wu)質研(yan)制和(he)(he)供(gong)(gong)應保障(zhang)。完(wan)善(shan)中(zhong)藥(yao)標(biao)準物(wu)質研(yan)制和(he)(he)持續保障(zhang)供(gong)(gong)應機制，強(qiang)化(hua)(hua)動(dong)態(tai)預警和(he)(he)信息反饋(kui)機制，開(kai)展需求分析并制訂研(yan)制計劃，加(jia)強(qiang)質量監測。分類完(wan)善(shan)中(zhong)藥(yao)化(hua)(hua)學(xue)對(dui)照(zhao)品、對(dui)照(zhao)藥(yao)材和(he)(he)對(dui)照(zhao)提取(qu)物(wu)等中(zhong)藥(yao)標(biao)準物(wu)質的研(yan)制和(he)(he)標(biao)定技術要求。

  （二十三）提升中(zhong)藥(yao)(yao)標(biao)準數(shu)字化管理水平(ping)。建立(li)完善(shan)中(zhong)藥(yao)(yao)國家藥(yao)(yao)品(pin)(pin)標(biao)準、藥(yao)(yao)品(pin)(pin)注冊(ce)標(biao)準動態數(shu)據庫，加快推進數(shu)字化標(biao)準建設，及時更新(xin)數(shu)據，實現藥(yao)(yao)品(pin)(pin)標(biao)準的發(fa)布、查詢、分析、研究(jiu)、維(wei)護信息(xi)化。

  七、加(jia)大中藥(yao)安(an)全監(jian)管(guan)力度(du)

  （二十四）創新中(zhong)(zhong)藥(yao)(yao)質量(liang)監管模式(shi)。逐(zhu)步構建(jian)(jian)“網格(ge)化(hua)”監管模式(shi)，完善(shan)中(zhong)(zhong)藥(yao)(yao)生產(chan)監管制(zhi)度建(jian)(jian)設(she)，研(yan)究制(zhi)定(ding)并(bing)監督(du)實施《中(zhong)(zhong)藥(yao)(yao)生產(chan)質量(liang)管理規范》。逐(zhu)步建(jian)(jian)立并(bing)完善(shan)中(zhong)(zhong)藥(yao)(yao)生產(chan)區域化(hua)風(feng)險研(yan)判機制(zhi)，針對(dui)重(zhong)點(dian)企業、重(zhong)點(dian)品種、重(zhong)點(dian)環(huan)節，持續加強(qiang)中(zhong)(zhong)藥(yao)(yao)飲片、中(zhong)(zhong)藥(yao)(yao)配方顆(ke)(ke)粒和(he)(he)中(zhong)(zhong)成(cheng)藥(yao)(yao)監督(du)檢查，有序(xu)開展(zhan)中(zhong)(zhong)藥(yao)(yao)材延(yan)伸檢查。進一步規范中(zhong)(zhong)藥(yao)(yao)飲片、中(zhong)(zhong)藥(yao)(yao)配方顆(ke)(ke)粒和(he)(he)中(zhong)(zhong)成(cheng)藥(yao)(yao)流通經營秩(zhi)序(xu)，強(qiang)化(hua)使(shi)用環(huan)節質量(liang)監管。

  （二十五(wu)）加強中(zhong)藥(yao)(yao)(yao)質量(liang)(liang)抽檢監(jian)(jian)測。持續推進(jin)和(he)完善中(zhong)藥(yao)(yao)(yao)飲片、中(zhong)藥(yao)(yao)(yao)配方顆粒、中(zhong)成藥(yao)(yao)(yao)質量(liang)(liang)抽檢，結合(he)監(jian)(jian)管需(xu)求和(he)行業發展實際科學開展探索性研究，對抽檢監(jian)(jian)測數據(ju)進(jin)行綜合(he)分析研判，依風(feng)險(xian)采取相應(ying)的風(feng)險(xian)防(fang)控或質量(liang)(liang)提升措施，優化中(zhong)藥(yao)(yao)(yao)質量(liang)(liang)公(gong)告發布工(gong)作機制，依法(fa)發布抽檢監(jian)(jian)測結果，向公(gong)眾客觀準(zhun)確傳遞中(zhong)藥(yao)(yao)(yao)質量(liang)(liang)安全信息。

  （二十六）嚴厲(li)(li)打(da)擊違法違規(gui)行(xing)(xing)為。依(yi)法嚴查重(zhong)處藥品(pin)上市許可持有人(ren)、生產(chan)和(he)/或(huo)經(jing)營企業(ye)涉(she)嫌注冊(ce)、備案(an)造(zao)假，以(yi)及(ji)摻雜摻假、編造(zao)記錄、違規(gui)銷(xiao)售(shou)等(deng)(deng)違法違規(gui)行(xing)(xing)為。嚴厲(li)(li)打(da)擊“窩點”制售(shou)中藥假藥等(deng)(deng)違法犯罪活動，充分利用(yong)網絡(luo)監(jian)測、投訴舉報等(deng)(deng)線(xian)索，聯(lian)合公安(an)、司法等(deng)(deng)部門，堅決查清源(yuan)頭、一追到底，依(yi)法追究犯罪人(ren)員(yuan)刑事責任，堅守中藥安(an)全底線(xian)。

  八(ba)、推進中藥監管全球化合作

  （二十(shi)七(qi)）充(chong)(chong)分發揮國際(ji)合(he)作(zuo)(zuo)平(ping)臺作(zuo)(zuo)用。進一(yi)步(bu)深化世界(jie)衛生組織（WHO）、國際(ji)草(cao)藥(yao)(yao)監管合(he)作(zuo)(zuo)組織（IRCH）、西太區草(cao)藥(yao)(yao)監管協調論(lun)壇(tan)（FHH）國際(ji)合(he)作(zuo)(zuo)，充(chong)(chong)分發揮“一(yi)帶一(yi)路”國際(ji)合(he)作(zuo)(zuo)框架、“中國-東盟藥(yao)(yao)品合(he)作(zuo)(zuo)發展高峰論(lun)壇(tan)”、世界(jie)衛生組織傳統(tong)醫(yi)藥(yao)(yao)合(he)作(zuo)(zuo)中心(xin)等(deng)(deng)平(ping)臺作(zuo)(zuo)用，積極推動在傳統(tong)草(cao)藥(yao)(yao)監管合(he)作(zuo)(zuo)、標準協調等(deng)(deng)方面進一(yi)步(bu)形(xing)成國際(ji)共識(shi)。

  （二十八）支持中(zhong)(zhong)藥(yao)(yao)開展(zhan)(zhan)國(guo)際注(zhu)冊。積(ji)極開展(zhan)(zhan)中(zhong)(zhong)藥(yao)(yao)國(guo)際注(zhu)冊政(zheng)策宣(xuan)貫和(he)交流，支持國(guo)內具有(you)臨(lin)床優勢(shi)的(de)(de)中(zhong)(zhong)藥(yao)(yao)開展(zhan)(zhan)國(guo)際注(zhu)冊，鼓勵開展(zhan)(zhan)中(zhong)(zhong)藥(yao)(yao)國(guo)際多(duo)中(zhong)(zhong)心臨(lin)床試(shi)驗。按計劃組織對進(jin)口藥(yao)(yao)材(cai)的(de)(de)產地、初加工(gong)等生產現場以及境(jing)外(wai)中(zhong)(zhong)藥(yao)(yao)（天然藥(yao)(yao)物）的(de)(de)研制、生產實施檢查。

  （二十九）傳播中藥監(jian)管“中國(guo)經驗”。加快推進中藥監(jian)管相關政策規(gui)定和(he)技(ji)術(shu)指導原(yuan)則(ze)翻譯工作，分批次(ci)印(yin)制(zhi)中藥相關技(ji)術(shu)指導原(yuan)則(ze)外文版本，加快國(guo)際推廣，為國(guo)際傳統草藥監(jian)管規(gui)則(ze)和(he)標準(zhun)制(zhi)修(xiu)訂貢(gong)獻“中國(guo)經驗”。

  九、保障措(cuo)施

  （三十）強(qiang)(qiang)化部(bu)(bu)門(men)聯動、協同(tong)推進。強(qiang)(qiang)化與衛生健康委、醫(yi)(yi)保局(ju)、中醫(yi)(yi)藥局(ju)等部(bu)(bu)門(men)協同(tong)聯動，在中藥相關重大政策制定過程中加強(qiang)(qiang)溝(gou)通交流，形成各部(bu)(bu)門(men)共(gong)同(tong)推進中藥傳承創新發展良好局(ju)面。

  （三十一）大(da)力(li)發展(zhan)中藥(yao)監(jian)管(guan)(guan)科學(xue)。研(yan)(yan)究制定中藥(yao)監(jian)管(guan)(guan)科學(xue)發展(zhan)戰(zhan)略(lve)和關鍵路徑，推(tui)進開(kai)展(zhan)國家藥(yao)監(jian)局(ju)藥(yao)品(pin)監(jian)管(guan)(guan)科學(xue)行動(dong)計(ji)劃(hua)。積(ji)極籌建藥(yao)品(pin)監(jian)管(guan)(guan)科學(xue)全國重點實驗室，依托國家藥(yao)監(jian)局(ju)藥(yao)品(pin)監(jian)管(guan)(guan)科學(xue)基地、重點實驗室和重點項(xiang)目實施，推(tui)動(dong)研(yan)(yan)究用于中藥(yao)評價的新(xin)(xin)工具(ju)、新(xin)(xin)方法和新(xin)(xin)標準，并建立促進其(qi)用于中藥(yao)監(jian)管(guan)(guan)的轉化認(ren)定程(cheng)序(xu)，建立完(wan)善(shan)具(ju)有(you)中國特色的中藥(yao)監(jian)管(guan)(guan)科學(xue)體系，解(jie)決中藥(yao)監(jian)管(guan)(guan)基礎性、關鍵性、前沿性和戰(zhan)略(lve)性技術問題。

  （三十二）加強高端(duan)智庫建(jian)設。充(chong)分發揮高端(duan)智庫作用，組建(jian)由中(zhong)醫藥(yao)領域和其他相(xiang)關學(xue)(xue)科(ke)領域的(de)院(yuan)士、國醫大師以及(ji)資深專家組成的(de)中(zhong)藥(yao)管理戰略決(jue)策專家咨詢委員會，建(jian)立(li)中(zhong)藥(yao)監(jian)管科(ke)學(xue)(xue)工作專家組，為(wei)國家藥(yao)監(jian)局提供相(xiang)關政策、法律咨詢，提出決(jue)策參考、工作建(jian)議，確保(bao)中(zhong)藥(yao)監(jian)管工作重(zhong)大決(jue)策的(de)科(ke)學(xue)(xue)性、權威性。

  （三(san)十(shi)三(san)）重(zhong)視監(jian)管(guan)科(ke)學(xue)人才隊伍培(pei)養。加強與高(gao)(gao)(gao)水平研究機構(gou)、高(gao)(gao)(gao)等院校以及行業學(xue)會、研究會等合(he)作(zuo)，構(gou)建(jian)中藥監(jian)管(guan)人才培(pei)養課程體系，分類別開展監(jian)管(guan)能力和實(shi)務培(pei)訓，培(pei)養一支適(shi)應(ying)中藥高(gao)(gao)(gao)質量發展的監(jian)管(guan)隊伍。

  （三十四）夯(hang)實中(zhong)(zhong)藥(yao)監管基(ji)(ji)礎(chu)建設。加強中(zhong)(zhong)藥(yao)監管基(ji)(ji)礎(chu)數(shu)據建設，開展數(shu)據科學研究，從(cong)技術標準、質量(liang)追(zhui)溯、過(guo)程監控、風險監測(ce)等方面，推動構(gou)建以數(shu)據為核心的(de)中(zhong)(zhong)藥(yao)智慧(hui)監管模式。

  （三十五）全面(mian)落(luo)(luo)實國家(jia)區(qu)域戰略。落(luo)(luo)實推進“京津冀協同發(fa)(fa)展”“長江三角洲區(qu)域一(yi)體化”“粵(yue)港澳大灣區(qu)建(jian)設”等國家(jia)區(qu)域發(fa)(fa)展戰略和中醫藥(yao)綜合改革示范(fan)區(qu)建(jian)設，鼓勵條(tiao)件成熟地(di)區(qu)藥(yao)品(pin)監督管(guan)理部門在(zai)加強中藥(yao)質(zhi)量(liang)(liang)安全監管(guan)，促進中藥(yao)產業更高質(zhi)量(liang)(liang)發(fa)(fa)展等方面(mian)先(xian)行先(xian)試。