一、《注(zhu)冊管理專(zhuan)門(men)規(gui)定(ding)》（以下簡稱《專(zhuan)門(men)規(gui)定(ding)》）的制定(ding)背景是什么？  

       自(zi)1985年(nian)《藥(yao)(yao)(yao)品管理法(fa)》實施(shi)以來，在不同歷史階段，國家(jia)藥(yao)(yao)(yao)品監督管理部門(men)針對中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)的(de)(de)特點和(he)研制規律，曾先(xian)后出臺過《中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)審批辦法(fa)》《<新藥(yao)(yao)(yao)審批辦法(fa)>有關中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)問題的(de)(de)補充規定和(he)說(shuo)明》等(deng)文件，不斷探索完善(shan)對中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)審批工作的(de)(de)管理。2008年(nian)，原(yuan)國家(jia)食藥(yao)(yao)(yao)監局發布了《中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注冊管理補充規定》（以下簡稱《補充規定》），至今已十余年(nian)。《補充規定》的(de)(de)實施(shi)對中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)事業的(de)(de)發展(zhan)起到了積極的(de)(de)推(tui)動作用。

  近年來，習近平總書記多次對中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)工作(zuo)作(zuo)出重要指示，《藥(yao)(yao)(yao)(yao)品(pin)管(guan)理(li)法(fa)》《中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)法(fa)》的(de)(de)(de)修訂頒布，《中(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)央(yang)(yang) 國(guo)務(wu)院(yuan)關(guan)于(yu)促進中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)傳承創(chuang)新(xin)發(fa)展(zhan)的(de)(de)(de)意見》《國(guo)務(wu)院(yuan)辦(ban)公廳關(guan)于(yu)加快中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)特色(se)發(fa)展(zhan)的(de)(de)(de)若干政策措施》陸(lu)續(xu)發(fa)布，全國(guo)中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)大會召開，我國(guo)中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)傳承創(chuang)新(xin)發(fa)展(zhan)邁進新(xin)時代(dai)。2018年機構改(gai)(gai)革后(hou)，國(guo)家藥(yao)(yao)(yao)(yao)監局(ju)黨組(zu)高度(du)重視中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)監管(guan)工作(zuo)，研究部(bu)署(shu)對《補(bu)充規(gui)(gui)定(ding)》作(zuo)進一步修訂完(wan)善。為(wei)全面落實《中(zhong)(zhong)(zhong)(zhong)共中(zhong)(zhong)(zhong)(zhong)央(yang)(yang) 國(guo)務(wu)院(yuan)關(guan)于(yu)促進中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)傳承創(chuang)新(xin)發(fa)展(zhan)的(de)(de)(de)意見》，并與新(xin)修訂《藥(yao)(yao)(yao)(yao)品(pin)管(guan)理(li)法(fa)》《藥(yao)(yao)(yao)(yao)品(pin)注冊管(guan)理(li)辦(ban)法(fa)》有機銜接，經研究決定(ding)對《補(bu)充規(gui)(gui)定(ding)》進行修訂，并將《補(bu)充規(gui)(gui)定(ding)》的(de)(de)(de)名稱修改(gai)(gai)為(wei)《專門規(gui)(gui)定(ding)》。

  二、《專(zhuan)門規定》的主要(yao)內容是(shi)什么？

  《專門(men)規定》共十(shi)一章，共82條。主(zhu)要內容分(fen)(fen)為總則、中(zhong)(zhong)藥(yao)注冊分(fen)(fen)類與上(shang)市(shi)審批、人用經(jing)驗證(zheng)據的合理應用、中(zhong)(zhong)藥(yao)創新藥(yao)、中(zhong)(zhong)藥(yao)改良型(xing)新藥(yao)、古(gu)代經(jing)典名(ming)方(fang)(fang)中(zhong)(zhong)藥(yao)復方(fang)(fang)制劑、同(tong)(tong)名(ming)同(tong)(tong)方(fang)(fang)藥(yao)、上(shang)市(shi)后變更、中(zhong)(zhong)藥(yao)注冊標準、藥(yao)品名(ming)稱和說明書、附(fu)則等。其中(zhong)(zhong)：

  第一章總(zong)則，共10條。強(qiang)調傳承與創新并重(zhong)，堅(jian)持以臨床價值為導(dao)向、中(zhong)醫(yi)藥理(li)論(lun)指導(dao)，注重(zhong)臨床實踐，改革、完善審評證據(ju)體系和療效結(jie)局指標；建立(li)符合中(zhong)藥特點(dian)的安全(quan)性(xing)評價要求，強(qiang)化中(zhong)藥研制全(quan)過(guo)程的質量(liang)控制，保障中(zhong)藥資源可持續利用。

  第(di)二章中(zhong)(zhong)(zhong)藥注冊分(fen)(fen)類(lei)與上市審批(pi)(pi)，共6條。明確中(zhong)(zhong)(zhong)藥注冊分(fen)(fen)類(lei)、研制(zhi)(zhi)路徑和模(mo)式(shi)，建立適合中(zhong)(zhong)(zhong)藥研制(zhi)(zhi)情形的簡化審批(pi)(pi)、優先審批(pi)(pi)、附(fu)條件審批(pi)(pi)、特別審批(pi)(pi)的相應規定。

  第(di)三章(zhang)人(ren)用(yong)(yong)(yong)經驗(yan)證據(ju)的(de)合理(li)應用(yong)(yong)(yong)，共11條。明(ming)(ming)確(que)了中藥(yao)人(ren)用(yong)(yong)(yong)經驗(yan)的(de)具體內涵，以及作為支(zhi)持(chi)中藥(yao)安全性(xing)、有效性(xing)證據(ju)的(de)合規性(xing)和藥(yao)學研(yan)究要求；明(ming)(ming)確(que)了合理(li)使用(yong)(yong)(yong)人(ren)用(yong)(yong)(yong)經驗(yan)證據(ju)支(zhi)持(chi)注冊申(shen)請，合理(li)豁免非臨床安全性(xing)研(yan)究及部分(fen)臨床試驗(yan)的(de)情形(xing)；引入真實世界證據(ju)作為支(zhi)持(chi)產(chan)品上(shang)市(shi)的(de)依據(ju)；對(dui)醫療機構中藥(yao)制(zhi)劑應用(yong)(yong)(yong)人(ren)用(yong)(yong)(yong)經驗(yan)的(de)情形(xing)進行明(ming)(ming)確(que)。

  第四章中藥(yao)創新(xin)藥(yao)，共13條。根據中藥(yao)特點分別規定了臨(lin)床、藥(yao)學及藥(yao)理(li)毒理(li)方面的相應要(yao)求，涉及明(ming)確中藥(yao)復方組方要(yao)求，新(xin)藥(yao)材及其制(zhi)劑、提取(qu)物及其制(zhi)劑研究基(ji)本原則(ze)和要(yao)求等。

  第五章中藥(yao)改(gai)(gai)良型(xing)(xing)新(xin)藥(yao)，共7條。明確改(gai)(gai)良型(xing)(xing)新(xin)藥(yao)研(yan)發(fa)的基本(ben)原則(ze)，并針對(dui)改(gai)(gai)劑型(xing)(xing)、改(gai)(gai)變給(gei)藥(yao)途徑、增(zeng)加功(gong)能主治、改(gai)(gai)變工(gong)藝(yi)或輔料(liao)等引起藥(yao)用物質基礎或藥(yao)物吸收、利用明顯改(gai)(gai)變等改(gai)(gai)良型(xing)(xing)新(xin)藥(yao)情形，分別提(ti)出研(yan)制要求。

  第(di)六章古(gu)代經(jing)典名方(fang)中(zhong)藥復方(fang)制劑(ji)，共6條。明確了(le)古(gu)代經(jing)典名方(fang)制劑(ji)的(de)注(zhu)冊管(guan)理總體要求、研(yan)制基本(ben)要求、審(shen)評模式，以及該類(lei)制劑(ji)上市(shi)后的(de)研(yan)究要求。

  第七(qi)章同(tong)(tong)名同(tong)(tong)方(fang)藥(yao)(yao)(yao)，共6條(tiao)。明確(que)了(le)同(tong)(tong)名同(tong)(tong)方(fang)藥(yao)(yao)(yao)的研制基本原則，規(gui)定(ding)了(le)對照同(tong)(tong)名同(tong)(tong)方(fang)藥(yao)(yao)(yao)的選擇要(yao)求，以及(ji)同(tong)(tong)名同(tong)(tong)方(fang)藥(yao)(yao)(yao)開展(zhan)臨(lin)床(chuang)試(shi)驗以及(ji)豁免(mian)臨(lin)床(chuang)試(shi)驗的條(tiao)件(jian)。

  第八(ba)章上市后變(bian)更(geng)(geng)，共8條。提出中(zhong)(zhong)藥(yao)上市后變(bian)更(geng)(geng)的(de)(de)總體(ti)要求(qiu)；明確了變(bian)更(geng)(geng)規格(ge)、生產工藝及輔料(liao)、適用人群(qun)、用法用量、處(chu)(chu)方藥(yao)味(wei)等常見變(bian)更(geng)(geng)情形的(de)(de)研(yan)制要求(qiu)；明確替代或減去國家藥(yao)品標準處(chu)(chu)方中(zhong)(zhong)的(de)(de)毒性藥(yao)味(wei)或處(chu)(chu)于(yu)瀕危狀(zhuang)態藥(yao)味(wei)、將處(chu)(chu)方中(zhong)(zhong)按新藥(yao)批準的(de)(de)提取物由(you)外購變(bian)更(geng)(geng)為自(zi)行提取、刪(shan)除(chu)主(zhu)治或者適用人群(qun)范圍等特(te)殊變(bian)更(geng)(geng)情形的(de)(de)研(yan)制要求(qiu)。

  第(di)九章(zhang)中(zhong)藥(yao)注冊(ce)標(biao)準(zhun)，共4條。明確(que)中(zhong)藥(yao)注冊(ce)標(biao)準(zhun)的研制目標(biao)，支持探(tan)索(suo)建立整(zheng)體(ti)質量控(kong)制方(fang)法和(he)持續完善(shan)中(zhong)藥(yao)質量標(biao)準(zhun)體(ti)系；明確(que)企業(ye)內控(kong)標(biao)準(zhun)與注冊(ce)標(biao)準(zhun)的關系。

  第十章藥(yao)(yao)品名稱和(he)說明(ming)書，共5條。明(ming)確(que)中(zhong)藥(yao)(yao)通用(yong)名稱的(de)(de)命名要(yao)求，對(dui)已上市中(zhong)藥(yao)(yao)的(de)(de)說明(ming)書完(wan)善(shan)提出(chu)了要(yao)求。對(dui)含毒性(xing)中(zhong)藥(yao)(yao)飲片(pian)的(de)(de)中(zhong)藥(yao)(yao)、主治(zhi)為(wei)證(zheng)候的(de)(de)中(zhong)藥(yao)(yao)復(fu)方制劑以及來源于古(gu)代經典名方中(zhong)藥(yao)(yao)復(fu)方制劑的(de)(de)說明(ming)書均(jun)作出(chu)了針對(dui)性(xing)的(de)(de)有(you)關要(yao)求。

  第十一章附則，共(gong)6條。主要(yao)包(bao)括天然藥(yao)(yao)物(wu)、境外已上市(shi)而境內未(wei)上市(shi)產品、中藥(yao)(yao)注(zhu)(zhu)射(she)劑等的研制(zhi)要(yao)求，以及醫療機構中藥(yao)(yao)制(zhi)劑的注(zhu)(zhu)冊管理有關(guan)規(gui)定(ding)。明(ming)確《專門(men)規(gui)定(ding)》施行日(ri)期等。

  三、《專門規定》的定位

  《專門規(gui)(gui)(gui)定(ding)》是在《補充規(gui)(gui)(gui)定(ding)》實(shi)施基礎上，充分吸(xi)納(na)藥(yao)(yao)(yao)品(pin)(pin)審(shen)(shen)評審(shen)(shen)批(pi)制(zhi)度(du)改革成(cheng)熟經驗，結合疫情防控中(zhong)藥(yao)(yao)(yao)成(cheng)果(guo)轉化實(shi)踐探(tan)索，借鑒國內(nei)(nei)外藥(yao)(yao)(yao)品(pin)(pin)監管科(ke)學研(yan)究成(cheng)果(guo)，全方(fang)位、系(xi)(xi)統地(di)構建了(le)中(zhong)藥(yao)(yao)(yao)注冊管理(li)(li)體(ti)系(xi)(xi)。《專門規(gui)(gui)(gui)定(ding)》是介于《藥(yao)(yao)(yao)品(pin)(pin)注冊管理(li)(li)辦法》和系(xi)(xi)列藥(yao)(yao)(yao)品(pin)(pin)研(yan)制(zhi)技(ji)(ji)術指導原則之間的(de)(de)規(gui)(gui)(gui)范(fan)性(xing)文件，內(nei)(nei)容既涉及中(zhong)藥(yao)(yao)(yao)注冊方(fang)面的(de)(de)行(xing)政管理(li)(li)事務，又涉及中(zhong)藥(yao)(yao)(yao)審(shen)(shen)評審(shen)(shen)批(pi)專業技(ji)(ji)術內(nei)(nei)容。《專門規(gui)(gui)(gui)定(ding)》對中(zhong)藥(yao)(yao)(yao)人(ren)用(yong)經驗的(de)(de)合理(li)(li)應用(yong)以及中(zhong)藥(yao)(yao)(yao)創新(xin)藥(yao)(yao)(yao)、中(zhong)藥(yao)(yao)(yao)改良型新(xin)藥(yao)(yao)(yao)、古代(dai)經典名方(fang)中(zhong)藥(yao)(yao)(yao)復方(fang)制(zhi)劑、同(tong)名同(tong)方(fang)藥(yao)(yao)(yao)等注冊分類的(de)(de)研(yan)制(zhi)原則和技(ji)(ji)術要(yao)求進行(xing)了(le)明確。《專門規(gui)(gui)(gui)定(ding)》通(tong)過必要(yao)的(de)(de)技(ji)(ji)術要(yao)求表述，進一(yi)步落實(shi)加(jia)快推進完善中(zhong)醫藥(yao)(yao)(yao)理(li)(li)論(lun)、人(ren)用(yong)經驗和臨床試驗相結合（以下(xia)簡稱“三結合”）的(de)(de)中(zhong)藥(yao)(yao)(yao)審(shen)(shen)評證據體(ti)系(xi)(xi)，體(ti)現中(zhong)藥(yao)(yao)(yao)注冊管理(li)(li)的(de)(de)新(xin)理(li)(li)念和改革舉措，并加(jia)強(qiang)了(le)對中(zhong)藥(yao)(yao)(yao)研(yan)制(zhi)的(de)(de)指導，具有較(jiao)強(qiang)的(de)(de)實(shi)操性(xing)。

  四、《專(zhuan)門(men)規定》主(zhu)要特點(dian)

  （一）將藥品(pin)的(de)基(ji)本要求(qiu)與中藥特殊性有機結合

  中(zhong)藥(yao)與其他藥(yao)品(pin)的(de)(de)共同點(dian)是以臨(lin)(lin)床(chuang)(chuang)(chuang)價值為(wei)導(dao)向，用于(yu)人(ren)(ren)體疾(ji)病的(de)(de)預防、治療、診(zhen)斷，而(er)不同點(dian)在于(yu)中(zhong)藥(yao)具(ju)有(you)豐富(fu)的(de)(de)臨(lin)(lin)床(chuang)(chuang)(chuang)人(ren)(ren)用經(jing)驗(yan)，中(zhong)藥(yao)的(de)(de)人(ren)(ren)用經(jing)驗(yan)蘊含(han)著重要的(de)(de)有(you)效(xiao)(xiao)性和安全(quan)性信息，“臨(lin)(lin)床(chuang)(chuang)(chuang)-實驗(yan)室-臨(lin)(lin)床(chuang)(chuang)(chuang)”是中(zhong)藥(yao)新藥(yao)研(yan)(yan)(yan)發的(de)(de)主要路徑(jing)和特(te)點(dian)。因此，《專(zhuan)門規定(ding)》遵循中(zhong)藥(yao)研(yan)(yan)(yan)制(zhi)規律(lv)和特(te)點(dian)，不斷強(qiang)化(hua)“以臨(lin)(lin)床(chuang)(chuang)(chuang)價值為(wei)導(dao)向、重視(shi)人(ren)(ren)用經(jing)驗(yan)、全(quan)過程(cheng)質(zhi)量(liang)控制(zhi)”等研(yan)(yan)(yan)制(zhi)理念，將(jiang)中(zhong)藥(yao)的(de)(de)生產(chan)工(gong)藝、質(zhi)量(liang)標準、藥(yao)效(xiao)(xiao)學(xue)、毒理學(xue)、臨(lin)(lin)床(chuang)(chuang)(chuang)研(yan)(yan)(yan)究等各研(yan)(yan)(yan)制(zhi)內容有(you)機結合，結合藥(yao)品(pin)安全(quan)性、有(you)效(xiao)(xiao)性、質(zhi)量(liang)可控性的(de)(de)基本要求，建立(li)起兼顧藥(yao)品(pin)基本要求，具(ju)有(you)中(zhong)藥(yao)特(te)點(dian)的(de)(de)審評審批體系。

  （二）辯證(zheng)處理好(hao)中(zhong)藥(yao)傳承與(yu)創(chuang)新的關系

  推動中(zhong)(zhong)藥(yao)(yao)高質(zhi)量發(fa)展，要善于(yu)傳(chuan)承(cheng)、勇(yong)于(yu)創(chuang)新(xin)。中(zhong)(zhong)醫藥(yao)(yao)具(ju)有(you)歷史悠久的(de)(de)(de)臨床實(shi)踐，為中(zhong)(zhong)藥(yao)(yao)研(yan)(yan)(yan)(yan)發(fa)提(ti)供了寶(bao)貴(gui)經(jing)驗和指導理(li)論；同時(shi)，中(zhong)(zhong)藥(yao)(yao)的(de)(de)(de)創(chuang)新(xin)發(fa)展，也需要充分運用現代(dai)科(ke)學(xue)技術。中(zhong)(zhong)藥(yao)(yao)的(de)(de)(de)傳(chuan)承(cheng)與創(chuang)新(xin)是相(xiang)互統一、相(xiang)互依(yi)存、相(xiang)互促進的(de)(de)(de)關系。《專門規(gui)定(ding)》明確(que)中(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)研(yan)(yan)(yan)(yan)制(zhi)應當注重體現中(zhong)(zhong)醫藥(yao)(yao)原創(chuang)思維及整體觀，鼓勵運用傳(chuan)統中(zhong)(zhong)藥(yao)(yao)研(yan)(yan)(yan)(yan)究(jiu)方(fang)(fang)法和現代(dai)科(ke)學(xue)技術研(yan)(yan)(yan)(yan)究(jiu)、開發(fa)中(zhong)(zhong)藥(yao)(yao)；支(zhi)持研(yan)(yan)(yan)(yan)制(zhi)基(ji)(ji)于(yu)古代(dai)經(jing)典名方(fang)(fang)、名老(lao)中(zhong)(zhong)醫經(jing)驗方(fang)(fang)、醫療機(ji)構中(zhong)(zhong)藥(yao)(yao)制(zhi)劑等具(ju)有(you)豐富中(zhong)(zhong)醫臨床實(shi)踐經(jing)驗的(de)(de)(de)中(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)。同時(shi)，《專門規(gui)定(ding)》鼓勵應用新(xin)興科(ke)學(xue)和技術研(yan)(yan)(yan)(yan)究(jiu)闡(chan)釋(shi)中(zhong)(zhong)藥(yao)(yao)的(de)(de)(de)作(zuo)用機(ji)理(li)，鼓勵將真(zhen)實(shi)世界研(yan)(yan)(yan)(yan)究(jiu)、新(xin)型生物(wu)標志(zhi)物(wu)、替(ti)代(dai)終(zhong)點(dian)決策(ce)、以患者為中(zhong)(zhong)心(xin)的(de)(de)(de)藥(yao)(yao)物(wu)研(yan)(yan)(yan)(yan)發(fa)、適應性設計(ji)、富集設計(ji)等用于(yu)中(zhong)(zhong)藥(yao)(yao)療效評(ping)價，在此基(ji)(ji)礎上推動中(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)研(yan)(yan)(yan)(yan)制(zhi)創(chuang)新(xin)。

  （三）充分尊重(zhong)中藥人(ren)用經(jing)驗(yan)

  中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)學極其注重(zhong)臨(lin)床實踐，中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)具有(you)悠(you)久的(de)(de)人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)和數據(ju)，人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)反映了中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)的(de)(de)實踐性特(te)點(dian)。中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)研(yan)制一(yi)般具有(you)“源于臨(lin)床，用(yong)于臨(lin)床”的(de)(de)特(te)點(dian)，中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)新藥(yao)(yao)(yao)在上市(shi)前多數已有(you)一(yi)定(ding)的(de)(de)人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)。將已有(you)的(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)整合(he)(he)入中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)的(de)(de)審評證(zheng)據(ju)體系(xi)，長期以(yi)來一(yi)直是業界的(de)(de)呼(hu)聲，也是藥(yao)(yao)(yao)品監管(guan)部門(men)積極探索構建符合(he)(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)特(te)點(dian)的(de)(de)審評技術(shu)評價體系(xi)的(de)(de)切(qie)入點(dian)。2021年以(yi)來，國家藥(yao)(yao)(yao)監局加(jia)快了構建“三結(jie)合(he)(he)”的(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)審評證(zheng)據(ju)體系(xi)步伐。《專門(men)規定(ding)》充分(fen)重(zhong)視(shi)“人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)”對(dui)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)安全(quan)(quan)性、有(you)效性的(de)(de)支撐，設立(li)專章，對(dui)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)的(de)(de)具體內涵(han)，作為支持(chi)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)安全(quan)(quan)性、有(you)效性證(zheng)據(ju)的(de)(de)合(he)(he)規性、藥(yao)(yao)(yao)學研(yan)究要(yao)求，以(yi)及人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)證(zheng)據(ju)支持(chi)注冊(ce)申請的(de)(de)情(qing)(qing)形(xing)等進行明(ming)確，促進了“三結(jie)合(he)(he)”審評證(zheng)據(ju)體系(xi)的(de)(de)加(jia)快建立(li)和完善(shan)；同(tong)時，還(huan)明(ming)確注冊(ce)申請人(ren)(ren)可根據(ju)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)人(ren)(ren)用(yong)經(jing)(jing)驗(yan)(yan)(yan)對(dui)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)安全(quan)(quan)性、有(you)效性的(de)(de)支持(chi)程度和不同(tong)情(qing)(qing)形(xing)，在研(yan)制時可選擇不同(tong)的(de)(de)臨(lin)床研(yan)究路徑，將極大地激發中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)新藥(yao)(yao)(yao)研(yan)制的(de)(de)活力。

&emsp; （四）系統闡(chan)釋了中(zhong)藥注冊分類研制原(yuan)則要求

  目前，調整(zheng)后的中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注(zhu)冊分(fen)(fen)類尊重中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)研發規(gui)(gui)律、突出中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)特(te)(te)色，鼓勵具有中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)特(te)(te)點的中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)復(fu)方制(zhi)(zhi)劑(ji)創新，注(zhu)重以(yi)臨床價值為導(dao)向，不(bu)再以(yi)物質(zhi)基礎作為劃(hua)分(fen)(fen)注(zhu)冊類別的依(yi)據。《專門規(gui)(gui)定》按(an)照調整(zheng)后的中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)注(zhu)冊分(fen)(fen)類（中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)創新藥(yao)(yao)(yao)、中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)改良型新藥(yao)(yao)(yao)、古(gu)代經典(dian)名(ming)(ming)方中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)復(fu)方制(zhi)(zhi)劑(ji)及同名(ming)(ming)同方藥(yao)(yao)(yao)等）的不(bu)同特(te)(te)點，分(fen)(fen)章節系統(tong)闡釋(shi)。依(yi)法簡化古(gu)代經典(dian)名(ming)(ming)方中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)復(fu)方制(zhi)(zhi)劑(ji)審批，構建(jian)與制(zhi)(zhi)劑(ji)特(te)(te)點相適應的審評模式，促進古(gu)代經典(dian)名(ming)(ming)方中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)復(fu)方制(zhi)(zhi)劑(ji)研發。

  （五）明確了中藥療效評價指(zhi)標的多元性(xing)

  《專門規定》基于中(zhong)(zhong)(zhong)醫藥(yao)(yao)在臨床中(zhong)(zhong)(zhong)發(fa)揮的作(zuo)用(yong)(yong)和特點，明確(que)了(le)中(zhong)(zhong)(zhong)藥(yao)(yao)的療(liao)效(xiao)評(ping)(ping)價(jia)(jia)(jia)應當結合中(zhong)(zhong)(zhong)醫藥(yao)(yao)臨床治療(liao)特點，確(que)定與(yu)中(zhong)(zhong)(zhong)藥(yao)(yao)臨床定位相適應、體(ti)現其作(zuo)用(yong)(yong)特點和優勢的療(liao)效(xiao)指標；挖(wa)掘中(zhong)(zhong)(zhong)醫藥(yao)(yao)臨床價(jia)(jia)(jia)值，列(lie)舉了(le)可(ke)作(zuo)為中(zhong)(zhong)(zhong)藥(yao)(yao)療(liao)效(xiao)評(ping)(ping)價(jia)(jia)(jia)的8種情(qing)(qing)形(xing)（對(dui)疾(ji)病(bing)痊愈或者延(yan)緩發(fa)展、病(bing)情(qing)(qing)或者癥狀改善、患(huan)者與(yu)疾(ji)病(bing)相關的機體(ti)功能或者生(sheng)存質量(liang)改善、與(yu)化(hua)學藥(yao)(yao)品(pin)等合用(yong)(yong)增效(xiao)減毒或者減少毒副(fu)作(zuo)用(yong)(yong)明顯的化(hua)學藥(yao)(yao)品(pin)使用(yong)(yong)劑量(liang)等情(qing)(qing)形(xing)），豐富了(le)以臨床價(jia)(jia)(jia)值為導(dao)向的多元化(hua)中(zhong)(zhong)(zhong)藥(yao)(yao)臨床療(liao)效(xiao)評(ping)(ping)價(jia)(jia)(jia)方法，促(cu)進了(le)中(zhong)(zhong)(zhong)醫藥(yao)(yao)獨特的評(ping)(ping)價(jia)(jia)(jia)方法與(yu)體(ti)系的建立，為中(zhong)(zhong)(zhong)藥(yao)(yao)新(xin)藥(yao)(yao)研制拓展思路。