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醫院傳統中藥制劑需備案管理
來(lai)源：醫藥網(wang)發布時(shi)間：2018-03-08點(dian)擊：9218次
2月12日，國(guo)家食品藥品監督(du)管(guan)理(li)(li)總局(ju)發布《對醫療(liao)機(ji)構應(ying)用(yong)(yong)傳統工(gong)藝(yi)配(pei)制(zhi)(zhi)(zhi)中藥制(zhi)(zhi)(zhi)劑(ji)實施備(bei)案(an)(an)(an)管(guan)理(li)(li)的(de)公告》，明確將由中藥飲(yin)片經水提取(qu)制(zhi)(zhi)(zhi)成的(de)顆粒劑(ji)以及由中藥飲(yin)片經粉碎后制(zhi)(zhi)(zhi)成的(de)膠(jiao)囊劑(ji)等，醫療(liao)機(ji)構應(ying)用(yong)(yong)傳統工(gong)藝(yi)配(pei)制(zhi)(zhi)(zhi)中藥制(zhi)(zhi)(zhi)劑(ji)實行備(bei)案(an)(an)(an)管(guan)理(li)(li)；傳統中藥制(zhi)(zhi)(zhi)劑(ji)限(xian)于取(qu)得該制(zhi)(zhi)(zhi)劑(ji)品種備(bei)案(an)(an)(an)號的(de)醫療(liao)機(ji)構使(shi)用(yong)(yong)，一(yi)般(ban)不(bu)得調(diao)劑(ji)使(shi)用(yong)(yong)，需(xu)要調(diao)劑(ji)使(shi)用(yong)(yong)的(de)，按照國(guo)家相(xiang)關(guan)規定執行；不(bu)得在市場(chang)上(shang)銷(xiao)(xiao)售或變(bian)相(xiang)銷(xiao)(xiao)售，不(bu)得發布醫療(liao)機(ji)構制(zhi)(zhi)(zhi)劑(ji)廣(guang)告。
《公告》所(suo)規定的(de)傳(chuan)統(tong)(tong)中藥(yao)(yao)(yao)制劑(ji)(ji)(ji)(ji)(ji)包(bao)括，由中藥(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)經粉碎或僅經水或油提取(qu)(qu)制成(cheng)的(de)固體（丸劑(ji)(ji)(ji)(ji)(ji)、散劑(ji)(ji)(ji)(ji)(ji)、丹劑(ji)(ji)(ji)(ji)(ji)、錠劑(ji)(ji)(ji)(ji)(ji)等(deng)(deng)(deng)）、半(ban)固體（膏滋(zi)、膏藥(yao)(yao)(yao)等(deng)(deng)(deng)）和液體（湯劑(ji)(ji)(ji)(ji)(ji)等(deng)(deng)(deng)）傳(chuan)統(tong)(tong)劑(ji)(ji)(ji)(ji)(ji)型(xing)；由中藥(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)經水提取(qu)(qu)制成(cheng)的(de)顆粒劑(ji)(ji)(ji)(ji)(ji)以(yi)及(ji)由中藥(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)經粉碎后制成(cheng)的(de)膠囊劑(ji)(ji)(ji)(ji)(ji)；由中藥(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)用傳(chuan)統(tong)(tong)方(fang)法提取(qu)(qu)制成(cheng)的(de)酒(jiu)劑(ji)(ji)(ji)(ji)(ji)、酊劑(ji)(ji)(ji)(ji)(ji)等(deng)(deng)(deng)。醫(yi)療(liao)機構所(suo)備案的(de)傳(chuan)統(tong)(tong)中藥(yao)(yao)(yao)制劑(ji)(ji)(ji)(ji)(ji)應(ying)與(yu)其《醫(yi)療(liao)機構執業(ye)許可(ke)證(zheng)》所(suo)載(zai)明的(de)診療(liao)范圍一致，與(yu)市場上已(yi)有(you)供應(ying)品(pin)種相同(tong)處(chu)方(fang)的(de)不(bu)同(tong)劑(ji)(ji)(ji)(ji)(ji)型(xing)品(pin)種、中藥(yao)(yao)(yao)配方(fang)顆粒等(deng)(deng)(deng)不(bu)得(de)備案。
國家食(shi)(shi)藥(yao)監管(guan)(guan)(guan)總局明確，各省(sheng)級食(shi)(shi)藥(yao)監管(guan)(guan)(guan)部(bu)門負責建立傳(chuan)統(tong)(tong)中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)備(bei)案(an)(an)信息平(ping)臺，醫療機構應(ying)通過所在(zai)地(di)省(sheng)級食(shi)(shi)藥(yao)監管(guan)(guan)(guan)部(bu)門備(bei)案(an)(an)信息平(ping)臺填(tian)報完(wan)整備(bei)案(an)(an)資料(liao)，平(ping)臺自(zi)動公開(kai)制(zhi)(zhi)劑(ji)名稱(cheng)、醫療機構名稱(cheng)、備(bei)案(an)(an)號等(deng)傳(chuan)統(tong)(tong)中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)備(bei)案(an)(an)的基本信息，傳(chuan)統(tong)(tong)中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)備(bei)案(an)(an)中(zhong)(zhong)(zhong)的內控(kong)制(zhi)(zhi)劑(ji)標(biao)準、處方、輔料(liao)、工藝參(can)數等(deng)資料(liao)不(bu)予公開(kai)。醫療機構配(pei)制(zhi)(zhi)傳(chuan)統(tong)(tong)中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)應(ying)取得(de)《醫療機構制(zhi)(zhi)劑(ji)許可證(zheng)》，不(bu)具(ju)資質(zhi)者可委托(tuo)(tuo)符(fu)合條件的單位配(pei)制(zhi)(zhi)，但須同時向委托(tuo)(tuo)方所在(zai)地(di)省(sheng)級食(shi)(shi)藥(yao)監管(guan)(guan)(guan)部(bu)門備(bei)案(an)(an)。
《公(gong)告》指出，傳統(tong)中(zhong)藥制(zhi)(zhi)(zhi)劑處(chu)方不(bu)得變更，其他備(bei)案(an)信息不(bu)得隨意變更，涉(she)及中(zhong)藥材標(biao)準(zhun)、中(zhong)藥飲片標(biao)準(zhun)或(huo)炮(pao)制(zhi)(zhi)(zhi)規范等影響制(zhi)(zhi)(zhi)劑質量(liang)的(de)(de)信息發生(sheng)變更的(de)(de)，備(bei)案(an)醫療機構應(ying)(ying)按相應(ying)(ying)程(cheng)序和要求(qiu)向原備(bei)案(an)部門進行備(bei)案(an)變更。醫療機構應(ying)(ying)進一(yi)步積累臨床使用中(zhong)的(de)(de)有(you)(you)效性數據，嚴格履行不(bu)良反應(ying)(ying)報告責(ze)任(ren)，建立不(bu)良反應(ying)(ying)監測及風險(xian)控制(zhi)(zhi)(zhi)體系(xi)。已取得批(pi)準(zhun)文(wen)號(hao)的(de)(de)傳統(tong)中(zhong)藥制(zhi)(zhi)(zhi)劑，在該(gai)批(pi)準(zhun)文(wen)號(hao)有(you)(you)效期屆滿后不(bu)予再注冊，符合備(bei)案(an)要求(qiu)的(de)(de)可按規定(ding)進行備(bei)案(an)。（首席記(ji)者劉志(zhi)勇）
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