2022-03-17
為貫(guan)徹落實(shi)《中(zhong)共中(zhong)央(yang) 國(guo)(guo)務院關(guan)于促(cu)進(jin)(jin)中(zhong)醫(yi)(yi)藥(yao)(yao)傳(chuan)承創新發展(zhan)的意見》，推進(jin)(jin)中(zhong)藥(yao)(yao)材規范化生產，加強中(zhong)藥(yao)(yao)材質(zhi)(zhi)量控(kong)制，促(cu)進(jin)(jin)中(zhong)藥(yao)(yao)高(gao)質(zhi)(zhi)量發展(zhan)，依據《中(zhong)華人民共和(he)國(guo)(guo)藥(yao)(yao)品(pin)管(guan)理(li)法》《中(zhong)華人民共和(he)國(guo)(guo)中(zhong)醫(yi)(yi)藥(yao)(yao)法》，國(guo)(guo)家藥(yao)(yao)監局(ju)、農業農村(cun)部、國(guo)(guo)家林草局(ju)、國(guo)(guo)家中(zhong)醫(yi)(yi)藥(yao)(yao)局(ju)研究制定(ding)了(le)《中(zhong)藥(yao)(yao)材生產質(zhi)(zhi)量管(guan)理(li)規范》（以下稱本規范），現(xian)予發布(bu)實(shi)施，并將有(you)關(guan)事項公(gong)告如下：
一(yi)、本規范適用(yong)于(yu)中(zhong)藥(yao)(yao)材(cai)生(sheng)(sheng)(sheng)(sheng)產企業(ye)規范生(sheng)(sheng)(sheng)(sheng)產中(zhong)藥(yao)(yao)材(cai)的(de)全(quan)過(guo)程(cheng)管理，是中(zhong)藥(yao)(yao)材(cai)規范化(hua)生(sheng)(sheng)(sheng)(sheng)產和管理的(de)基本要求。本規范涉及的(de)中(zhong)藥(yao)(yao)材(cai)是指來源于(yu)藥(yao)(yao)用(yong)植物、藥(yao)(yao)用(yong)動物等資源，經規范化(hua)的(de)種(zhong)植（含(han)生(sheng)(sheng)(sheng)(sheng)態(tai)種(zhong)植、野生(sheng)(sheng)(sheng)(sheng)撫育(yu)和仿(fang)野生(sheng)(sheng)(sheng)(sheng)栽培）、養殖、采收和產地加工(gong)后，用(yong)于(yu)生(sheng)(sheng)(sheng)(sheng)產中(zhong)藥(yao)(yao)飲片(pian)、中(zhong)藥(yao)(yao)制劑(ji)的(de)藥(yao)(yao)用(yong)原料。
 本公告所指中藥(yao)材生產企(qi)業包括具(ju)有企(qi)業性質的種植(zhi)、養(yang)殖專業合作社或聯合社。
二、鼓勵中藥(yao)飲片(pian)生(sheng)產企業、中成藥(yao)上市許可持(chi)有人等中藥(yao)生(sheng)產企業在中藥(yao)材(cai)產地(di)自建、共建符合本規范的中藥(yao)材(cai)生(sheng)產企業及生(sheng)產基地(di)，將藥(yao)品質量(liang)管理體系延伸(shen)到中藥(yao)材(cai)產地(di)。
鼓勵(li)中(zhong)藥(yao)(yao)(yao)生(sheng)(sheng)(sheng)產企業優先使用符合(he)本規范要(yao)求(qiu)(qiu)的中(zhong)藥(yao)(yao)(yao)材(cai)。藥(yao)(yao)(yao)品批(pi)準證明文件等(deng)有明確要(yao)求(qiu)(qiu)的，中(zhong)藥(yao)(yao)(yao)生(sheng)(sheng)(sheng)產企業應(ying)當(dang)按照(zhao)規定使用符合(he)本規范要(yao)求(qiu)(qiu)的中(zhong)藥(yao)(yao)(yao)材(cai)。相關中(zhong)藥(yao)(yao)(yao)生(sheng)(sheng)(sheng)產企業應(ying)當(dang)依法(fa)開(kai)展供應(ying)商審(shen)核(he)，按照(zhao)本規范要(yao)求(qiu)(qiu)進行(xing)審(shen)核(he)檢(jian)查，保證符合(he)要(yao)求(qiu)(qiu)。
三(san)、使(shi)用符合本(ben)規范要(yao)(yao)求(qiu)的(de)中藥材，相關中藥生產(chan)企業可以(yi)(yi)參照藥品標(biao)簽管(guan)理的(de)相關規定(ding)，在藥品標(biao)簽中適(shi)當位置(zhi)標(biao)示“藥材符合GAP要(yao)(yao)求(qiu)”，可以(yi)(yi)依法進(jin)行宣傳(chuan)。對中藥復方(fang)制劑，所有處方(fang)成份均符合本(ben)規范要(yao)(yao)求(qiu)，方(fang)可標(biao)示。
省級藥(yao)品監(jian)督管理部門應當(dang)(dang)加強監(jian)督檢查，對應當(dang)(dang)使用或者標示使用符(fu)合本規范(fan)中(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)(cai)的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)生產(chan)企(qi)(qi)業，必要時對相應的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)(cai)生產(chan)企(qi)(qi)業開(kai)展延伸檢查，重(zhong)點檢查是否符(fu)合本規范(fan)。發現不符(fu)合的(de)，應當(dang)(dang)依法嚴厲查處，責令中(zhong)(zhong)(zhong)(zhong)藥(yao)生產(chan)企(qi)(qi)業限期(qi)改(gai)正、取消標示等，并公(gong)開(kai)相應的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)(cai)生產(chan)企(qi)(qi)業及其(qi)中(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)(cai)品種，通報中(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)(cai)產(chan)地人民(min)政(zheng)府。
四、各省(sheng)(sheng)(sheng)相關管理部門(men)在省(sheng)(sheng)(sheng)委省(sheng)(sheng)(sheng)政(zheng)府領導下，配合和(he)協助中藥(yao)(yao)(yao)材(cai)(cai)產(chan)地人(ren)民(min)政(zheng)府做(zuo)好中藥(yao)(yao)(yao)材(cai)(cai)規(gui)(gui)范(fan)化(hua)發(fa)(fa)(fa)展(zhan)工(gong)作，如完善中藥(yao)(yao)(yao)材(cai)(cai)產(chan)業高質量發(fa)(fa)(fa)展(zhan)工(gong)作機(ji)制；制定中藥(yao)(yao)(yao)材(cai)(cai)產(chan)業發(fa)(fa)(fa)展(zhan)規(gui)(gui)劃；細化(hua)推(tui)進(jin)中藥(yao)(yao)(yao)材(cai)(cai)規(gui)(gui)范(fan)化(hua)發(fa)(fa)(fa)展(zhan)的激勵(li)政(zheng)策；建立(li)中藥(yao)(yao)(yao)材(cai)(cai)生(sheng)產(chan)企業及(ji)其生(sheng)產(chan)基(ji)地臺(tai)賬和(he)信(xin)用檔案，實施動態監管；建立(li)中藥(yao)(yao)(yao)材(cai)(cai)規(gui)(gui)范(fan)化(hua)生(sheng)產(chan)追溯信(xin)息(xi)化(hua)平臺(tai)等。鼓(gu)勵(li)中藥(yao)(yao)(yao)材(cai)(cai)規(gui)(gui)范(fan)化(hua)、集約化(hua)生(sheng)產(chan)基(ji)礎較(jiao)好的省(sheng)(sheng)(sheng)份，結合本(ben)轄區中藥(yao)(yao)(yao)材(cai)(cai)發(fa)(fa)(fa)展(zhan)實際，研究制定實施細則(ze)，積極(ji)探索推(tui)進(jin)，為本(ben)規(gui)(gui)范(fan)的深入(ru)推(tui)廣積累經驗。
五、各省相(xiang)關管理(li)部(bu)門依職責對(dui)本規范的實施和推(tui)進進行檢查和技(ji)術指(zhi)導(dao)(dao)(dao)。農(nong)業農(nong)村(cun)部(bu)門牽頭做好(hao)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)種(zhong)(zhong)子種(zhong)(zhong)苗及種(zhong)(zhong)源提供、田間(jian)管理(li)、農(nong)藥(yao)(yao)(yao)和肥料使用(yong)、病蟲害(hai)防治等(deng)指(zhi)導(dao)(dao)(dao)。林業和草原(yuan)部(bu)門牽頭做好(hao)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)生(sheng)(sheng)態種(zhong)(zhong)植(zhi)、野生(sheng)(sheng)撫(fu)育(yu)、仿野生(sheng)(sheng)栽培，以(yi)及屬于(yu)瀕危管理(li)范疇的中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)種(zhong)(zhong)植(zhi)、養(yang)殖等(deng)指(zhi)導(dao)(dao)(dao)。中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)管理(li)部(bu)門協同做好(hao)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)種(zhong)(zhong)子種(zhong)(zhong)苗、規范種(zhong)(zhong)植(zhi)、采收加(jia)工以(yi)及生(sheng)(sheng)態種(zhong)(zhong)植(zhi)等(deng)指(zhi)導(dao)(dao)(dao)。藥(yao)(yao)(yao)品(pin)監(jian)督管理(li)部(bu)門對(dui)相(xiang)應的中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)生(sheng)(sheng)產(chan)企(qi)業開展延伸檢查，做好(hao)藥(yao)(yao)(yao)用(yong)要求、產(chan)地加(jia)工、質量檢驗等(deng)指(zhi)導(dao)(dao)(dao)。
六、各省相(xiang)關管理部(bu)門(men)應加強協作，形成(cheng)合力，共(gong)同推進中(zhong)藥(yao)材規(gui)(gui)范化(hua)、標準(zhun)化(hua)、集約(yue)化(hua)發(fa)展，按職責(ze)強化(hua)宣(xuan)傳培訓，推動本規(gui)(gui)范落地實施。加強實施中(zhong)日常(chang)監(jian)管，如(ru)發(fa)現(xian)存在(zai)重大問題或者有重大政(zheng)策(ce)完(wan)善建(jian)議的，請及時報告國家相(xiang)應的管理部(bu)門(men)。
特(te)此公告。
附(fu)件：中藥材生產質量管理規范(fan)
國家藥監局 農業(ye)農村(cun)部 國家林草局(ju) 國家中醫(yi)藥局(ju)
2022年3月1日
