一、《中(zhong)藥標準管理專門規定(ding)》制定(ding)的目的和意義是什么？

　　藥(yao)(yao)品(pin)(pin)(pin)標(biao)準是保(bao)障藥(yao)(yao)品(pin)(pin)(pin)安全(quan)有效(xiao)的(de)重(zhong)(zhong)要基(ji)(ji)礎，是藥(yao)(yao)品(pin)(pin)(pin)監(jian)管(guan)(guan)工(gong)作(zuo)的(de)準繩，也是一個國家醫(yi)藥(yao)(yao)產(chan)業發(fa)展和(he)監(jian)管(guan)(guan)水平(ping)的(de)重(zhong)(zhong)要體(ti)現，在藥(yao)(yao)品(pin)(pin)(pin)監(jian)管(guan)(guan)體(ti)系和(he)監(jian)管(guan)(guan)能力(li)現代(dai)化建設中發(fa)揮著(zhu)基(ji)(ji)礎性、引領性作(zuo)用。2023年7月，國家局(ju)發(fa)布了(le)《藥(yao)(yao)品(pin)(pin)(pin)標(biao)準管(guan)(guan)理辦法》，第一次(ci)全(quan)面系統地(di)制定了(le)藥(yao)(yao)品(pin)(pin)(pin)標(biao)準管(guan)(guan)理的(de)制度和(he)要求，對規范藥(yao)(yao)品(pin)(pin)(pin)標(biao)準管(guan)(guan)理工(gong)作(zuo)，必將發(fa)揮重(zhong)(zhong)要的(de)作(zuo)用。

　　新(xin)(xin)時代發(fa)(fa)展中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)，尤(you)其是在(zai)如何做好守正(zheng)創(chuang)新(xin)(xin)，如何推動中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)產業高質量發(fa)(fa)展等方面(mian)需要有新(xin)(xin)思路、新(xin)(xin)舉(ju)措(cuo)。在(zai)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)過程(cheng)中(zhong)(zhong)(zhong)(zhong)，需要將“最嚴(yan)謹的(de)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)”要求(qiu)貫(guan)穿中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)全鏈條，同時做好傳承精華，守正(zheng)創(chuang)新(xin)(xin)，建立(li)符合中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)特(te)點(dian)的(de)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)體系(xi)，成為中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)的(de)重(zhong)要課題。國家藥(yao)(yao)監(jian)局黨組高度重(zhong)視(shi)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)工作，在(zai)《國家藥(yao)(yao)監(jian)局關于(yu)印(yin)發(fa)(fa)進一步(bu)加強中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)科學(xue)監(jian)管(guan)促進中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)傳承創(chuang)新(xin)(xin)發(fa)(fa)展若干措(cuo)施的(de)通(tong)知》中(zhong)(zhong)(zhong)(zhong)，對(dui)“研(yan)究制(zhi)定中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)專門規定”提出(chu)明確要求(qiu)。《中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)專門規定》的(de)制(zhi)定和(he)發(fa)(fa)布，對(dui)于(yu)加強中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管(guan)理(li)(li)(li)，建立(li)和(he)完(wan)善符合中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)特(te)點(dian)的(de)標(biao)(biao)(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)體系(xi)，促進中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)傳承創(chuang)新(xin)(xin)發(fa)(fa)展，具有重(zhong)要意義。

　　二、《中藥標準管理(li)(li)專門規定》與(yu)《藥品標準管理(li)(li)辦法(fa)》是什么關系？

　　對于中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理而言，《藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理辦(ban)法(fa)(fa)》與《中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理專(zhuan)門(men)規定(ding)》是“一(yi)般(ban)”與“特(te)(te)殊(shu)(shu)”的(de)(de)(de)關系。《藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理辦(ban)法(fa)(fa)》明確(que)了藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理工作的(de)(de)(de)基本要求，對藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理的(de)(de)(de)基本制度、工作程序以及各方(fang)職責(ze)作出了明確(que)規定(ding)。《中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理專(zhuan)門(men)規定(ding)》基于中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)自身特(te)(te)點，將藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理的(de)(de)(de)一(yi)般(ban)性程序與中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)自身特(te)(te)殊(shu)(shu)性相結合。在《藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)(pin)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理辦(ban)法(fa)(fa)》通用(yong)性規定(ding)的(de)(de)(de)基礎上，《中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理專(zhuan)門(men)規定(ding)》按照中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)材、中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)飲片(pian)、中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)提取物與配方(fang)顆粒、中(zhong)成藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)等中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)產品(pin)(pin)屬性分類(lei)，進一(yi)步對中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)標(biao)(biao)(biao)準(zhun)管(guan)(guan)理的(de)(de)(de)各項要求進行(xing)細(xi)化和(he)明確(que)，彰顯(xian)中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)特(te)(te)殊(shu)(shu)性。

      ; 三、《中藥標(biao)準(zhun)管理專門(men)規定》如何推進(jin)符(fu)合(he)中醫(yi)藥特點的標(biao)準(zhun)體系的構建？

　　中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)是(shi)(shi)(shi)在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)理論指導下使用(yong)的(de)(de)(de)(de)(de)(de)藥(yao)(yao)(yao)品，中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)準(zhun)的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)、制(zhi)(zhi)(zhi)定(ding)(ding)(ding)(ding)和(he)(he)(he)管理必須充分(fen)考(kao)慮到(dao)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)的(de)(de)(de)(de)(de)(de)自(zi)身特(te)點(dian)(dian)。在(zai)《中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)準(zhun)管理專門規定(ding)(ding)(ding)(ding)》起草過程(cheng)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)，將遵循(xun)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)理論、尊重中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)傳(chuan)(chuan)統(tong)(tong)，體(ti)現中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)特(te)色作為必須把(ba)握的(de)(de)(de)(de)(de)(de)根(gen)本原則。一是(shi)(shi)(shi)強調中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)標(biao)準(zhun)的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)和(he)(he)(he)制(zhi)(zhi)(zhi)定(ding)(ding)(ding)(ding)，應注(zhu)(zhu)重對(dui)(dui)傳(chuan)(chuan)統(tong)(tong)質(zhi)量(liang)(liang)評價(jia)方法進(jin)行(xing)研究(jiu)(jiu)和(he)(he)(he)傳(chuan)(chuan)承，鼓勵對(dui)(dui)道地藥(yao)(yao)(yao)材(cai)的(de)(de)(de)(de)(de)(de)品質(zhi)特(te)征進(jin)行(xing)系統(tong)(tong)評價(jia)和(he)(he)(he)研究(jiu)(jiu)。二是(shi)(shi)(shi)強調中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片標(biao)準(zhun)的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)和(he)(he)(he)制(zhi)(zhi)(zhi)定(ding)(ding)(ding)(ding)，應當注(zhu)(zhu)重傳(chuan)(chuan)統(tong)(tong)炮(pao)制(zhi)(zhi)(zhi)經(jing)驗的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)和(he)(he)(he)傳(chuan)(chuan)承，重點(dian)(dian)關(guan)注(zhu)(zhu)炮(pao)制(zhi)(zhi)(zhi)過程(cheng)及炮(pao)制(zhi)(zhi)(zhi)終點(dian)(dian)的(de)(de)(de)(de)(de)(de)判定(ding)(ding)(ding)(ding)，對(dui)(dui)具有“減毒增效(xiao)”以(yi)及“生熟異(yi)治(zhi)”特(te)點(dian)(dian)的(de)(de)(de)(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片，應當建(jian)立針對(dui)(dui)性(xing)質(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)方法，科學合(he)理設置(zhi)質(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)項(xiang)(xiang)目。三(san)是(shi)(shi)(shi)強調中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)標(biao)準(zhun)的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)和(he)(he)(he)制(zhi)(zhi)(zhi)定(ding)(ding)(ding)(ding)，應當根(gen)據功能(neng)主治(zhi)、“君臣(chen)佐使”等組方規律及臨床使用(yong)情況，科學合(he)理設置(zhi)質(zhi)量(liang)(liang)控制(zhi)(zhi)(zhi)項(xiang)(xiang)目。四是(shi)(shi)(shi)強調中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)配方顆粒標(biao)準(zhun)的(de)(de)(de)(de)(de)(de)研究(jiu)(jiu)和(he)(he)(he)制(zhi)(zhi)(zhi)定(ding)(ding)(ding)(ding)，應當重點(dian)(dian)關(guan)注(zhu)(zhu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)配方顆粒與傳(chuan)(chuan)統(tong)(tong)湯劑基本質(zhi)量(liang)(liang)屬性(xing)的(de)(de)(de)(de)(de)(de)一致性(xing)。

       四、《中(zhong)(zhong)藥(yao)標準管理專門規定(ding)》在優化中(zhong)(zhong)藥(yao)標準形成(cheng)機(ji)制(zhi)方面(mian)采取了(le)哪些措施？

　　中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)形成機制(zhi)在很大程(cheng)度上影響著(zhu)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)工(gong)作(zuo)的(de)(de)質量和(he)(he)效(xiao)率。為進(jin)一(yi)步優化中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)形成機制(zhi)，《中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管理(li)(li)專門(men)規定》積極探(tan)索中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)監管新舉(ju)措(cuo)，引入(ru)(ru)新的(de)(de)工(gong)作(zuo)機制(zhi)。一(yi)是(shi)引入(ru)(ru)競(jing)爭機制(zhi)，對中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)國(guo)家標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)修(xiu)訂(ding)實(shi)施課題管理(li)(li)，各相關(guan)單位(wei)(wei)可(ke)公(gong)(gong)開(kai)申報，擇優確定標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)課題承(cheng)擔單位(wei)(wei)。二是(shi)全面深化公(gong)(gong)開(kai)機制(zhi)，強(qiang)(qiang)調標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)提高課題立項信息、起草(cao)單位(wei)(wei)、樣品信息、研(yan)究草(cao)案甚至(zhi)審核專家及審核意見的(de)(de)對外公(gong)(gong)開(kai)，確保(bao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)工(gong)作(zuo)公(gong)(gong)開(kai)、公(gong)(gong)平、公(gong)(gong)正。三是(shi)進(jin)一(yi)步強(qiang)(qiang)化鼓勵機制(zhi)。《中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)管理(li)(li)專門(men)規定》嚴格落實(shi)《關(guan)于進(jin)一(yi)步加(jia)強(qiang)(qiang)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)科學監管促(cu)進(jin)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)傳承(cheng)創新發展的(de)(de)若干措(cuo)施》的(de)(de)有關(guan)要求，將企業和(he)(he)社會(hui)第三方(fang)直接申請(qing)修(xiu)訂(ding)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)國(guo)家標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)納(na)入(ru)(ru)藥(yao)(yao)(yao)品標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)形成機制(zhi)。四是(shi)構建中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)快速(su)修(xiu)訂(ding)機制(zhi)，要求制(zhi)定相關(guan)配套(tao)文件，加(jia)快相關(guan)品種的(de)(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)標(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)修(xiu)訂(ding)工(gong)作(zuo)。

　　五、《中藥(yao)標準管理專(zhuan)門規定》在推進中藥(yao)標準協調(diao)管理工作方面采(cai)取了哪些措施？

　　中藥標準涉及部門較多，情況較為復雜。《中藥標準管理專門規定》重點對中藥標準管理過程中可能涉及的協調問題進行了明確。一是加強省級中藥標準、中藥注冊標準和中藥國家標準的協調，明確需制定中藥國家標準和核發中藥注冊標準的情形。提出建立中藥注冊標準、省級中藥標準轉化中藥國家標準的工作機制，加強各類標準的融合與轉化。二是明確中成藥國家標準修訂涉及上市后變更管理的銜接事項。對中成藥國家標準中涉及的重大變更和中等變更的，應按照上市后變更管理相應規定獲得批準或備案后，可對標準中相關內容進行修訂；涉及微小變更的，可對標準相關內容進行修訂后，由藥品生產企業按上市后變更管理相應要求進行年報即可。三是進一步理順中藥通用名稱管理機制。明確僅有注冊標準的中藥通用名稱修訂的程序，參照《藥品注冊管理辦法》通用名稱核準有關程序，由藥品生產企業按照補充申請要求進行申報，由藥品審評中心通知藥典委員會核準通用名稱并提供相關資料，藥典委員會核準后反饋藥品審評中心。
                                                                                                                                                                                                                                                                                                                                                                  文章來源于(yu)國家藥品監督管理局