cciia.org.cn 2025-9-8 21:02:51 國(guo)家藥(yao)品監督(du)管理(li)局
一、《中藥生(sheng)產監督管理專門規定》的制(zhi)定背景是什么?
習近平總書(shu)記(ji)指出，中(zhong)醫(yi)藥(yao)(yao)是(shi)中(zhong)華文明(ming)的(de)瑰寶，要(yao)與時俱(ju)進(jin)、守正創新，要(yao)推進(jin)中(zhong)醫(yi)藥(yao)(yao)產(chan)業(ye)化(hua)、現代化(hua)。黨的(de)二(er)十屆三中(zhong)全會決定中(zhong)要(yao)求完善中(zhong)醫(yi)藥(yao)(yao)傳承創新發(fa)展(zhan)(zhan)機制。近期，《國(guo)務(wu)院辦(ban)(ban)公廳關于全面深化(hua)藥(yao)(yao)品醫(yi)療器械監管(guan)改(gai)革促(cu)進(jin)醫(yi)藥(yao)(yao)產(chan)業(ye)高質(zhi)量(liang)發(fa)展(zhan)(zhan)的(de)意見(jian)》(國(guo)辦(ban)(ban)發(fa)〔2024〕53號)、《國(guo)務(wu)院辦(ban)(ban)公廳關于提(ti)升(sheng)中(zhong)藥(yao)(yao)質(zhi)量(liang)促(cu)進(jin)中(zhong)醫(yi)藥(yao)(yao)產(chan)業(ye)高質(zhi)量(liang)發(fa)展(zhan)(zhan)的(de)意見(jian)》(國(guo)辦(ban)(ban)發(fa)〔2025〕11號)先后印(yin)發(fa)，要(yao)求健(jian)全符合中(zhong)藥(yao)(yao)特點的(de)監管(guan)體系(xi)(xi)，明(ming)確加強中(zhong)藥(yao)(yao)資源保護、加快(kuai)推進(jin)中(zhong)藥(yao)(yao)產(chan)業(ye)轉型升(sheng)級、強化(hua)中(zhong)藥(yao)(yao)質(zhi)量(liang)監管(guan)等(deng)系(xi)(xi)列任(ren)務(wu)，促(cu)進(jin)中(zhong)藥(yao)(yao)質(zhi)量(liang)提(ti)升(sheng)。
《中藥(yao)生產(chan)監(jian)督(du)管(guan)(guan)理(li)專門(men)規(gui)定》(以(yi)下(xia)稱(cheng)《規(gui)定》)是堅持以(yi)習近平新時代中國(guo)(guo)特色社(she)會主義思想為(wei)指導，貫徹落實黨中央、國(guo)(guo)務院決(jue)策部(bu)署(shu)，按照“講政治、強監(jian)管(guan)(guan)、保安全、促(cu)發展、惠民生”的工作思路，根據《藥(yao)品(pin)(pin)管(guan)(guan)理(li)法》《中醫藥(yao)法》《藥(yao)品(pin)(pin)生產(chan)監(jian)督(du)管(guan)(guan)理(li)辦(ban)法》等制定的規(gui)范性文件。
二、《規定(ding)》的(de)定(ding)位和主要特點是(shi)什(shen)么(me)?
《規(gui)(gui)(gui)定》是(shi)在《藥(yao)(yao)品生產(chan)(chan)(chan)監督管(guan)理(li)辦法》和(he)《藥(yao)(yao)品生產(chan)(chan)(chan)質(zhi)(zhi)量(liang)管(guan)理(li)規(gui)(gui)(gui)范》及(ji)其相關(guan)附錄基(ji)礎上，根(gen)據中藥(yao)(yao)生產(chan)(chan)(chan)特點制定的(de)專門(men)要(yao)求，是(shi)進(jin)一(yi)步加強(qiang)(qiang)和(he)規(gui)(gui)(gui)范中藥(yao)(yao)生產(chan)(chan)(chan)及(ji)其監督管(guan)理(li)的(de)補充。《規(gui)(gui)(gui)定》遵循中醫藥(yao)(yao)發展規(gui)(gui)(gui)律，體現中藥(yao)(yao)生產(chan)(chan)(chan)特點，立足中藥(yao)(yao)生產(chan)(chan)(chan)實際，綜(zong)合既有(you)監管(guan)經驗，突出(chu)強(qiang)(qiang)調從中藥(yao)(yao)材基(ji)原管(guan)控(kong)、規(gui)(gui)(gui)范生產(chan)(chan)(chan)，直到藥(yao)(yao)品出(chu)廠放行、上市后監測評價和(he)風險控(kong)制等全鏈(lian)條、全環節(jie)和(he)全過程質(zhi)(zhi)量(liang)控(kong)制。聚焦影響中藥(yao)(yao)生產(chan)(chan)(chan)和(he)質(zhi)(zhi)量(liang)的(de)源(yuan)頭(tou)問題、關(guan)鍵環節(jie)，提(ti)出(chu)針對性(xing)解決(jue)措施，著眼中藥(yao)(yao)材規(gui)(gui)(gui)范化(hua)發展，鼓(gu)勵(li)中藥(yao)(yao)生產(chan)(chan)(chan)加快改造升級，推進(jin)數智化(hua)轉型。《規(gui)(gui)(gui)定》的(de)實施，將為嚴(yan)格把關(guan)源(yuan)頭(tou)質(zhi)(zhi)量(liang)、加強(qiang)(qiang)中藥(yao)(yao)生產(chan)(chan)(chan)全過程控(kong)制、提(ti)升中藥(yao)(yao)質(zhi)(zhi)量(liang)、因地制宜發展中藥(yao)(yao)新質(zhi)(zhi)生產(chan)(chan)(chan)力(li)發揮(hui)積極作用。
三、《規定》如何推進符合中藥特(te)點的生(sheng)產監管體(ti)系建設?
《規定(ding)》以打造(zao)科學、高(gao)效、權威(wei)的(de)，符合中(zhong)藥(yao)(yao)(yao)生(sheng)(sheng)產(chan)特點的(de)監(jian)(jian)(jian)(jian)管(guan)(guan)(guan)體系(xi)為目標(biao)。強(qiang)調中(zhong)藥(yao)(yao)(yao)材質(zhi)量評估，加(jia)強(qiang)供(gong)應(ying)商審核，有(you)序推(tui)行(xing)中(zhong)藥(yao)(yao)(yao)材生(sheng)(sheng)產(chan)質(zhi)量管(guan)(guan)(guan)理(li)規范(中(zhong)藥(yao)(yao)(yao)材GAP)，引導(dao)中(zhong)藥(yao)(yao)(yao)企(qi)(qi)業將質(zhi)量管(guan)(guan)(guan)理(li)體系(xi)延伸到中(zhong)藥(yao)(yao)(yao)材生(sheng)(sheng)產(chan)全(quan)過(guo)程，減少(shao)中(zhong)藥(yao)(yao)(yao)材供(gong)應(ying)中(zhong)間環節(jie)。加(jia)強(qiang)生(sheng)(sheng)產(chan)過(guo)程質(zhi)量控(kong)制，優化(hua)(hua)工藝驗證(zheng)規定(ding)，明確均一化(hua)(hua)處理(li)和提(ti)(ti)取(qu)浸(jin)膏偏差控(kong)制要求(qiu)，強(qiang)化(hua)(hua)中(zhong)藥(yao)(yao)(yao)委托、受托生(sheng)(sheng)產(chan)及恢復生(sheng)(sheng)產(chan)的(de)研究驗證(zheng)及其監(jian)(jian)(jian)(jian)督管(guan)(guan)(guan)理(li)，嚴格中(zhong)藥(yao)(yao)(yao)注射劑生(sheng)(sheng)產(chan)監(jian)(jian)(jian)(jian)管(guan)(guan)(guan)，監(jian)(jian)(jian)(jian)督企(qi)(qi)業保(bao)證(zheng)中(zhong)藥(yao)(yao)(yao)質(zhi)量。指(zhi)導(dao)和監(jian)(jian)(jian)(jian)督企(qi)(qi)業完善風險管(guan)(guan)(guan)理(li)，細化(hua)(hua)豁免檢驗、委托檢驗、共(gong)享檢驗設備(bei)和結果的(de)監(jian)(jian)(jian)(jian)管(guan)(guan)(guan)要求(qiu);完善異地或(huo)者共(gong)用前處理(li)、提(ti)(ti)取(qu)車(che)間的(de)監(jian)(jian)(jian)(jian)管(guan)(guan)(guan)措施;明確溶劑折算(suan)原(yuan)則和回(hui)收使用要求(qiu);減少(shao)重復建設，推(tui)動資源高(gao)效利用。
四、《規定》在(zai)嚴把中(zhong)藥材質量方面有哪(na)些要求?
《規定》強調，中(zhong)藥(yao)(yao)(yao)企業應(ying)當(dang)依法(fa)開展中(zhong)藥(yao)(yao)(yao)材(cai)的質量(liang)(liang)評(ping)(ping)估(gu)(gu)，加強供應(ying)商審核(he)，強化驗收、檢(jian)驗、檢(jian)查和(he)儲(chu)運養護等(deng)管(guan)理(li);進一步(bu)明確(que)和(he)強調產地(di)加工(gong)(趁鮮(xian)切制)中(zhong)藥(yao)(yao)(yao)材(cai)、進口中(zhong)藥(yao)(yao)(yao)材(cai)、特(te)殊管(guan)理(li)中(zhong)藥(yao)(yao)(yao)材(cai)的采購及使用要(yao)求。企業應(ying)當(dang)通(tong)過質量(liang)(liang)評(ping)(ping)估(gu)(gu)、技術(shu)審核(he)等(deng)做到中(zhong)藥(yao)(yao)(yao)材(cai)基(ji)原(yuan)準確(que)、來源清楚(chu)、加工(gong)和(he)倉儲(chu)規范，保證符(fu)合(he)藥(yao)(yao)(yao)用要(yao)求。審核(he)評(ping)(ping)估(gu)(gu)方法(fa)包含傳(chuan)統(tong)判斷(duan)、基(ji)原(yuan)鑒定、檢(jian)驗檢(jian)測，還可以應(ying)用AI等(deng)新興技術(shu)進行輔助評(ping)(ping)估(gu)(gu)。
五、《規(gui)定》對推行中藥材GAP有哪些措(cuo)施?
中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP是中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)規范化生(sheng)產(chan)的(de)(de)(de)技(ji)術規范，在中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)質量(liang)(liang)源頭(tou)提(ti)升中(zhong)(zhong)(zhong)具有重要(yao)作用(yong)。《國(guo)(guo)務院辦公廳關于提(ti)升中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)質量(liang)(liang)促進(jin)中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)(yao)產(chan)業高(gao)質量(liang)(liang)發展的(de)(de)(de)意(yi)見》(國(guo)(guo)辦發〔2025〕11號(hao))要(yao)求(qiu)(qiu)持續推(tui)行(xing)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP。《規定》結(jie)合(he)近年(nian)來中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP監督(du)實施(shi)(shi)情況，重申中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)注(zhu)射劑(ji)原(yuan)則上應(ying)(ying)(ying)當(dang)使用(yong)、中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)配方顆(ke)粒應(ying)(ying)(ying)當(dang)優先使用(yong)符合(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP的(de)(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)，明(ming)確中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)企業可(ke)以引用(yong)符合(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP要(yao)求(qiu)(qiu)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)的(de)(de)(de)已(yi)有資料開展質量(liang)(liang)評估(gu)，并通過驗收(shou)管(guan)理、差異(yi)化監管(guan)、豁免檢驗等(deng)具體措施(shi)(shi)助推(tui)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)GAP實施(shi)(shi)，引導中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)企業將(jiang)質量(liang)(liang)管(guan)理體系延(yan)伸到中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)生(sheng)產(chan)全(quan)過程，保證源頭(tou)質量(liang)(liang)，減少中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)供應(ying)(ying)(ying)中(zhong)(zhong)(zhong)間環節。
六、《規定(ding)》對優(you)化中(zhong)藥提取物管理(li)有哪些(xie)舉措(cuo)?
中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)包(bao)括(kuo)揮發油、油脂、浸膏(gao)(gao)、流浸膏(gao)(gao)、干(gan)浸膏(gao)(gao)、有(you)效(xiao)成份、有(you)效(xiao)部(bu)位(wei)等。2014年原食(shi)品藥(yao)(yao)(yao)(yao)(yao)品監(jian)管總(zong)局印發《關(guan)于加(jia)強中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)生(sheng)產(chan)中(zhong)(zhong)(zhong)(zhong)提(ti)(ti)(ti)取(qu)(qu)和提(ti)(ti)(ti)取(qu)(qu)物(wu)監(jian)督管理(li)的(de)(de)通知(zhi)》(食(shi)藥(yao)(yao)(yao)(yao)(yao)監(jian)藥(yao)(yao)(yao)(yao)(yao)化(hua)(hua)監(jian)〔2014〕135號，以下(xia)稱135號文(wen)件(jian))，對(dui)中(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)(yao)(yao)國家(jia)(jia)藥(yao)(yao)(yao)(yao)(yao)品標(biao)準處方項下(xia)載明，且具(ju)(ju)有(you)單獨國家(jia)(jia)藥(yao)(yao)(yao)(yao)(yao)品標(biao)準的(de)(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)實(shi)施備(bei)(bei)案(an)(an)管理(li)，明確生(sheng)產(chan)備(bei)(bei)案(an)(an)和使用(yong)備(bei)(bei)案(an)(an)的(de)(de)要求(qiu)、程序。《規定(ding)》重(zhong)申中(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)(yao)(yao)用(yong)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)應(ying)(ying)當按照135號文(wen)件(jian)要求(qiu)備(bei)(bei)案(an)(an)，并結(jie)合(he)監(jian)管實(shi)際，明確持(chi)有(you)人可以備(bei)(bei)案(an)(an)多家(jia)(jia)供應(ying)(ying)商(shang)，以及(ji)自提(ti)(ti)(ti)自用(yong)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)的(de)(de)無需備(bei)(bei)案(an)(an);并通過強化(hua)(hua)物(wu)料管理(li)、生(sheng)產(chan)過程控制(zhi)等，監(jian)督持(chi)有(you)人保證原料用(yong)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)質(zhi)量。按照135號文(wen)件(jian)，實(shi)施備(bei)(bei)案(an)(an)管理(li)的(de)(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)提(ti)(ti)(ti)取(qu)(qu)物(wu)不包(bao)括(kuo)中(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)(yao)(yao)國家(jia)(jia)藥(yao)(yao)(yao)(yao)(yao)品標(biao)準中(zhong)(zhong)(zhong)(zhong)附有(you)具(ju)(ju)體制(zhi)法或標(biao)準的(de)(de)提(ti)(ti)(ti)取(qu)(qu)物(wu)，相(xiang)關(guan)持(chi)有(you)人應(ying)(ying)當自行(xing)組織(zhi)提(ti)(ti)(ti)取(qu)(qu);也不包(bao)括(kuo)按新藥(yao)(yao)(yao)(yao)(yao)批(pi)準的(de)(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)有(you)效(xiao)成份或者有(you)效(xiao)部(bu)位(wei)，相(xiang)關(guan)持(chi)有(you)人應(ying)(ying)當按照批(pi)準要求(qiu)組織(zhi)生(sheng)產(chan)。
七、《規定》對中(zhong)成藥委托(tuo)生產(chan)有(you)哪些專門要求?
委(wei)托(tuo)生(sheng)(sheng)產(chan)(chan)中成藥(yao)(yao)應(ying)當(dang)(dang)嚴格執行國家藥(yao)(yao)監(jian)局(ju)對(dui)藥(yao)(yao)品委(wei)托(tuo)和受(shou)托(tuo)生(sheng)(sheng)產(chan)(chan)管理的要(yao)求(qiu)(qiu)。對(dui)已通過(guo)藥(yao)(yao)品再注冊但藥(yao)(yao)品再注冊周期內未(wei)開展商業化(hua)規(gui)模(mo)生(sheng)(sheng)產(chan)(chan)的中成藥(yao)(yao)，持有人應(ying)當(dang)(dang)先(xian)完成恢復(fu)生(sheng)(sheng)產(chan)(chan)，確保質(zhi)量(liang)穩定，保證(zheng)雙方能夠(gou)更好(hao)地履(lv)行委(wei)托(tuo)協(xie)議(yi)和質(zhi)量(liang)協(xie)議(yi)。恢復(fu)生(sheng)(sheng)產(chan)(chan)的相關(guan)(guan)工作應(ying)當(dang)(dang)由持有人按照國家藥(yao)(yao)監(jian)局(ju)關(guan)(guan)于境內生(sheng)(sheng)產(chan)(chan)藥(yao)(yao)品再注冊申報程序等規(gui)定完成。持有人可以(yi)自行組(zu)(zu)織研(yan)究(jiu)驗證(zheng)，也可以(yi)參照委(wei)托(tuo)生(sheng)(sheng)產(chan)(chan)程序，組(zu)(zu)織具(ju)有藥(yao)(yao)品生(sheng)(sheng)產(chan)(chan)資質(zhi)且符合(he)產(chan)(chan)品生(sheng)(sheng)產(chan)(chan)要(yao)求(qiu)(qiu)的擬受(shou)托(tuo)生(sheng)(sheng)產(chan)(chan)企業研(yan)究(jiu)驗證(zheng)。
八、《規定》如何(he)強調(diao)內(nei)控質量標(biao)準和鼓勵標(biao)準提高?
藥(yao)品(pin)(pin)的(de)(de)內控質量(liang)(liang)(liang)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)是(shi)企(qi)業(ye)(ye)(ye)按(an)照藥(yao)品(pin)(pin)生(sheng)產(chan)(chan)質量(liang)(liang)(liang)管理(li)規范等(deng)要(yao)求，在(zai)國(guo)家(jia)藥(yao)品(pin)(pin)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)、藥(yao)品(pin)(pin)注(zhu)冊標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)或者省(sheng)級中藥(yao)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)基(ji)礎上，為更好地保證產(chan)(chan)品(pin)(pin)質量(liang)(liang)(liang)而制(zhi)定的(de)(de)更為嚴謹的(de)(de)企(qi)業(ye)(ye)(ye)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)。《規定》明(ming)確了持(chi)有人(ren)、中藥(yao)生(sheng)產(chan)(chan)企(qi)業(ye)(ye)(ye)制(zhi)定內控質量(liang)(liang)(liang)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)的(de)(de)基(ji)本要(yao)求、研究對象和(he)主(zhu)要(yao)技術等(deng)，提(ti)(ti)升質量(liang)(liang)(liang)控制(zhi)水平和(he)操作性。同時，指導和(he)督(du)促持(chi)有人(ren)、中藥(yao)生(sheng)產(chan)(chan)企(qi)業(ye)(ye)(ye)通過持(chi)續提(ti)(ti)高藥(yao)品(pin)(pin)注(zhu)冊標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)，主(zhu)動參與提(ti)(ti)高國(guo)家(jia)藥(yao)品(pin)(pin)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)、省(sheng)級中藥(yao)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)等(deng)，將成(cheng)熟的(de)(de)企(qi)業(ye)(ye)(ye)內控質量(liang)(liang)(liang)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)轉(zhuan)化為普適性、強制(zhi)性標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)，發(fa)(fa)揮標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)在(zai)中藥(yao)質量(liang)(liang)(liang)提(ti)(ti)升的(de)(de)重(zhong)要(yao)作用，發(fa)(fa)揮企(qi)業(ye)(ye)(ye)科技創新主(zhu)體作用。
九、《規定》在優化中藥(yao)檢驗方面有哪些要求(qiu)?
檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)是質(zhi)(zhi)(zhi)量(liang)(liang)控制的(de)(de)重要手段。《規定(ding)》堅持風險(xian)(xian)管理(li)(li)，保(bao)障產(chan)品質(zhi)(zhi)(zhi)量(liang)(liang)，持續優化中(zhong)(zhong)藥(yao)(yao)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)，合(he)理(li)(li)減(jian)少重復檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)。中(zhong)(zhong)藥(yao)(yao)企業(ye)通過質(zhi)(zhi)(zhi)量(liang)(liang)審(shen)核和(he)(he)風險(xian)(xian)評(ping)估，可以(yi)引用(yong)(yong)(yong)(yong)待包(bao)裝(zhuang)產(chan)品的(de)(de)部分檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)對成(cheng)品進行質(zhi)(zhi)(zhi)量(liang)(liang)評(ping)價(jia);也可以(yi)有條(tiao)件引用(yong)(yong)(yong)(yong)中(zhong)(zhong)藥(yao)(yao)材部分項目(mu)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)進行產(chan)品質(zhi)(zhi)(zhi)量(liang)(liang)評(ping)價(jia)。同一集團內(nei)執行統(tong)一質(zhi)(zhi)(zhi)量(liang)(liang)管理(li)(li)體系的(de)(de)企業(ye)使(shi)用(yong)(yong)(yong)(yong)同一批號中(zhong)(zhong)藥(yao)(yao)材、中(zhong)(zhong)藥(yao)(yao)飲(yin)片、中(zhong)(zhong)藥(yao)(yao)提(ti)取物等(deng)原料及輔料、包(bao)裝(zhuang)材料的(de)(de)，經質(zhi)(zhi)(zhi)量(liang)(liang)審(shen)核和(he)(he)風險(xian)(xian)評(ping)估后可以(yi)共享檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)。明(ming)確成(cheng)本高昂且使(shi)用(yong)(yong)(yong)(yong)頻次(ci)較少的(de)(de)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)設備(如ICP-MS、GC-MS-MS、LC-MS-MS及PCR擴增儀等(deng))，相關檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)項目(mu)可以(yi)委托(tuo)具(ju)有資質(zhi)(zhi)(zhi)的(de)(de)第三方檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)機構開(kai)展，或(huo)者與同一集團內(nei)執行統(tong)一質(zhi)(zhi)(zhi)量(liang)(liang)管理(li)(li)體系的(de)(de)企業(ye)共用(yong)(yong)(yong)(yong)設備。引用(yong)(yong)(yong)(yong)或(huo)者共享的(de)(de)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)應當注(zhu)明(ming)數據來(lai)源。為嚴(yan)格中(zhong)(zhong)藥(yao)(yao)注(zhu)射劑(ji)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)管理(li)(li)，中(zhong)(zhong)藥(yao)(yao)注(zhu)射劑(ji)不能引用(yong)(yong)(yong)(yong)或(huo)者共享檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)。委托(tuo)檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)應當嚴(yan)格符合(he)藥(yao)(yao)品生產(chan)質(zhi)(zhi)(zhi)量(liang)(liang)管理(li)(li)規范(fan)要求(qiu)，檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)委托(tuo)方應當對檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)結(jie)果(guo)負責，檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)(yan)受(shou)托(tuo)方應當有義務接受(shou)藥(yao)(yao)品監督管理(li)(li)部門監督檢(jian)(jian)(jian)(jian)(jian)查。
十、《規(gui)定》對中藥生產過程控制明確了哪些要(yao)求?
《規定》強(qiang)調(diao)中藥(yao)(yao)(yao)生(sheng)(sheng)產應(ying)當(dang)加(jia)強(qiang)過程(cheng)(cheng)管理，嚴格制定生(sheng)(sheng)產工(gong)(gong)藝(yi)規程(cheng)(cheng)，明(ming)確關鍵工(gong)(gong)藝(yi)參數，防止污染、交(jiao)叉污染及(ji)混淆等。具體包括：清洗后(hou)直接投料的(de)，應(ying)當(dang)按照折(zhe)干率計算投料量;中藥(yao)(yao)(yao)飲片的(de)工(gong)(gong)藝(yi)驗(yan)證(zheng)(zheng)應(ying)當(dang)結合傳統(tong)屬性判(pan)斷標準(zhun)(zhun)(如蒸、炒、炙、煅(duan)的(de)“火候(hou)”等);工(gong)(gong)藝(yi)再(zai)驗(yan)證(zheng)(zheng)涉及(ji)相同(tong)生(sheng)(sheng)產線(xian)的(de)，可(ke)以選取(qu)其中一條(tiao)驗(yan)證(zheng)(zheng)，合理減少重(zhong)復驗(yan)證(zheng)(zheng);對相應(ying)藥(yao)(yao)(yao)品標準(zhun)(zhun)或核(he)準(zhun)(zhun)工(gong)(gong)藝(yi)未明(ming)確的(de)，但中成藥(yao)(yao)(yao)生(sheng)(sheng)產已實際使用的(de)滅菌工(gong)(gong)藝(yi)，且按照藥(yao)(yao)(yao)品上市(shi)后(hou)變更(geng)管理規定無需重(zhong)新申報的(de)，持有人應(ying)當(dang)完善研究驗(yan)證(zheng)(zheng)工(gong)(gong)作，并(bing)在工(gong)(gong)藝(yi)規程(cheng)(cheng)中明(ming)確后(hou)，在藥(yao)(yao)(yao)品年度報告中填報。
十一、《規定》對中(zhong)藥生產均一化(hua)處(chu)理有哪些要求?
為減少(shao)原料(liao)(liao)質(zhi)量(liang)波(bo)動帶來的(de)中(zhong)藥(yao)產(chan)品(pin)(pin)質(zhi)量(liang)差異(yi)，提(ti)高中(zhong)藥(yao)批(pi)(pi)間(jian)(jian)穩定性，《規定》明(ming)確持(chi)有人、中(zhong)藥(yao)生(sheng)產(chan)企(qi)業可以參照(zhao)中(zhong)藥(yao)均(jun)(jun)一(yi)化(hua)(hua)(hua)研究技術指導原則，在研究論證基礎上，對中(zhong)藥(yao)材、中(zhong)藥(yao)飲(yin)片(pian)、中(zhong)藥(yao)提(ti)取(qu)物(wu)等(deng)原料(liao)(liao)進(jin)行均(jun)(jun)一(yi)化(hua)(hua)(hua)處(chu)(chu)理(li)后投料(liao)(liao)，實施(shi)均(jun)(jun)一(yi)化(hua)(hua)(hua)處(chu)(chu)理(li)的(de)原料(liao)(liao)應當規范生(sheng)產(chan)且符(fu)合質(zhi)量(liang)要求。下一(yi)步，將結合中(zhong)藥(yao)生(sheng)產(chan)均(jun)(jun)一(yi)化(hua)(hua)(hua)處(chu)(chu)理(li)實施(shi)進(jin)展(zhan)，進(jin)一(yi)步探索推進(jin)中(zhong)藥(yao)生(sheng)產(chan)過程中(zhong)的(de)提(ti)取(qu)液、浸膏等(deng)均(jun)(jun)一(yi)化(hua)(hua)(hua)處(chu)(chu)理(li)，持(chi)續增強中(zhong)藥(yao)產(chan)品(pin)(pin)批(pi)(pi)間(jian)(jian)質(zhi)量(liang)穩定性，促進(jin)中(zhong)藥(yao)質(zhi)量(liang)提(ti)升。
十二、《規定》在推進資源循(xun)環(huan)利用方面有哪些措(cuo)施?
《國務院(yuan)辦(ban)公廳關于提升中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)質量(liang)促進中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)產(chan)(chan)業高質量(liang)發展的意見》(國辦(ban)發〔2025〕11號)要求建設高水(shui)平綠(lv)色(se)工(gong)廠，推進中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)資(zi)源(yuan)循(xun)環利(li)用(yong)(yong)。《規定(ding)》結(jie)合(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)生產(chan)(chan)實(shi)際(ji)和監管實(shi)踐，明(ming)確(que)提取溶劑(ji)(主要指(zhi)工(gong)藝或者(zhe)制法中(zhong)(zhong)(zhong)載明(ming)的乙醇等有(you)機溶劑(ji))的回收和再(zai)利(li)用(yong)(yong)要求，重點(dian)強(qiang)調防止污染和交(jiao)叉污染。強(qiang)調有(you)效防范提取藥(yao)(yao)(yao)渣廢料非法利(li)用(yong)(yong)(如(ru)經干(gan)燥、染色(se)等非法操作后再(zai)回流至(zhi)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)生產(chan)(chan)環節)，同(tong)時，鼓勵持有(you)人、中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)生產(chan)(chan)企業開展中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)資(zi)源(yuan)綠(lv)色(se)循(xun)環綜合(he)研究(jiu)和利(li)用(yong)(yong)。
十(shi)三、《規定》如(ru)何促進(jin)傳統中(zhong)藥生(sheng)產改造升級，因地制(zhi)宜發展中(zhong)藥新(xin)質(zhi)生(sheng)產力(li)?
《國務院辦公(gong)廳關于提升中(zhong)(zhong)藥(yao)(yao)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)促進中(zhong)(zhong)醫藥(yao)(yao)產(chan)業(ye)高(gao)(gao)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)發(fa)(fa)展的意見(jian)》(國辦發(fa)(fa)〔2025〕11號)要求提升中(zhong)(zhong)藥(yao)(yao)制造(zao)(zao)(zao)品質(zhi)(zhi)(zhi)(zhi)(zhi)，打(da)造(zao)(zao)(zao)知(zhi)名中(zhong)(zhong)藥(yao)(yao)品牌。隨著信(xin)息技術快(kuai)速(su)發(fa)(fa)展，人工智能(neng)、智能(neng)制造(zao)(zao)(zao)將推動藥(yao)(yao)品行業(ye)向高(gao)(gao)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)、高(gao)(gao)效(xiao)(xiao)率、可持(chi)續(xu)發(fa)(fa)展，部分中(zhong)(zhong)藥(yao)(yao)企(qi)業(ye)已在(zai)(zai)生產(chan)改造(zao)(zao)(zao)升級、降本(ben)增效(xiao)(xiao)方面積累(lei)經驗，奠(dian)定(ding)品牌建設(she)基礎。《規(gui)定(ding)》明(ming)確鼓勵企(qi)業(ye)將質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)管理(li)體系延伸到中(zhong)(zhong)藥(yao)(yao)材生產(chan)全過(guo)程，運用現代(dai)科技加(jia)快(kuai)自動化、數字化、智能(neng)化建設(she)，有序建立關鍵環節(jie)的可視(shi)化視(shi)頻監控(kong)，探索應用在(zai)(zai)線檢驗和(he)監測，逐(zhu)步采(cai)用信(xin)息化實時記(ji)錄替代(dai)傳(chuan)統紙質(zhi)(zhi)(zhi)(zhi)(zhi)記(ji)錄，促進中(zhong)(zhong)藥(yao)(yao)數智化轉型(xing);同時，持(chi)續(xu)強化原料質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)審(shen)核，加(jia)強過(guo)程控(kong)制，嚴(yan)格質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)管理(li)，引導和(he)督促企(qi)業(ye)在(zai)(zai)保證質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)基礎上(shang)，推動生產(chan)改造(zao)(zao)(zao)升級，提升中(zhong)(zhong)藥(yao)(yao)質(zhi)(zhi)(zhi)(zhi)(zhi)量(liang)(liang)(liang)，打(da)造(zao)(zao)(zao)更好的中(zhong)(zhong)藥(yao)(yao)品牌，發(fa)(fa)展中(zhong)(zhong)藥(yao)(yao)新質(zhi)(zhi)(zhi)(zhi)(zhi)生產(chan)力。
日期：2025-9-8 21:02:51 | 關閉 |
Copyright © 1999-2021 法律圖書(shu)館
.
.
