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今天兩個(gè)重磅炸彈，一個(gè)藥品管理法，一個(gè)注冊(cè)管理辦法，都是修正稿征求意見(jiàn)。我當(dāng)然比較關(guān)心藥品管理法。一個(gè)是法，一個(gè)是辦法，你說(shuō)哪個(gè)重要？
雖然只是修正稿，而不是修訂稿，但是，確有幾處重大的修改。
1、藥品上市許可持有有制度寫入《藥品管理法》 ，此制度將由試點(diǎn)改為全面推開！
2、取消GMP、GSP認(rèn)證這兩項(xiàng)行政許可！但請(qǐng)注意，絕不是取消GMP和GSP。所有的藥品生產(chǎn)企業(yè)，必須嚴(yán)格按照《藥品生產(chǎn)質(zhì)量管理規(guī)范》（GMP）要求組織生產(chǎn)。
3、明確要求建立職業(yè)化的藥品檢查員隊(duì)伍（而不是GMP\GSP檢查員隊(duì)伍）。以后的監(jiān)管將由定期監(jiān)管將常態(tài)化監(jiān)管轉(zhuǎn)變！
附全文
總局辦公廳公開征求《〈中華人民共和國(guó)藥品管理法〉修正案
（草案征求意見(jiàn)稿）》意見(jiàn)
10月1日，中央辦公廳、國(guó)務(wù)院辦公廳印發(fā)《關(guān)于深化審評(píng)審批制度改革鼓勵(lì)藥品醫(yī)療器械創(chuàng)新的意見(jiàn)》（以下簡(jiǎn)稱《創(chuàng)新意見(jiàn)》），提出36項(xiàng)重要改革措施。為保障有關(guān)改革措施落實(shí)于法有據(jù)，食品藥品監(jiān)管總局就目前急需修改《中華人民共和國(guó)藥品管理法》的內(nèi)容進(jìn)行認(rèn)真研究，形成《中華人民共和國(guó)藥品管理法修正案（草案征求意見(jiàn)稿）》，現(xiàn)向社會(huì)公開征求意見(jiàn)。為確?！秳?chuàng)新意見(jiàn)》相關(guān)改革措施盡快實(shí)施，此次《中華人民共和國(guó)藥品管理法》只是局部修改，請(qǐng)社會(huì)各界緊緊圍繞《創(chuàng)新意見(jiàn)》提出的改革措施，提出意見(jiàn)和建議，請(qǐng)將意見(jiàn)和建議通過(guò)電子郵件的形式于2017年10月30日前反饋食品藥品監(jiān)管總局法制司，并請(qǐng)注明“藥品管理法修正案”。根據(jù)十二屆全國(guó)人大常委會(huì)立法工作安排，食品藥品監(jiān)管總局正在加快推進(jìn)《中華人民共和國(guó)藥品管理法》的全面修訂，將適時(shí)另行征求意見(jiàn)。聯(lián)系郵箱：xuxy@cfda.gov.cn
附件：1.《中華人民共和國(guó)藥品管理法》修正案（草案征求意見(jiàn)稿）有關(guān)情況的說(shuō)明
2.《中華人民共和國(guó)藥品管理法》修正案（草案征求意見(jiàn)稿）
3.《中華人民共和國(guó)藥品管理法》修正案草案花臉稿
食品藥品監(jiān)管總局辦公廳
2017年10月23日
附件1
《中華人民共和國(guó)藥品管理法》修正案（草案征求意見(jiàn)稿）有關(guān)情況的說(shuō)明
10月1日，中央辦辦公廳、國(guó)務(wù)院辦公廳印發(fā)《關(guān)于深化審評(píng)審批制度改革鼓勵(lì)藥品醫(yī)療器械創(chuàng)新的意見(jiàn)》（以下簡(jiǎn)稱《創(chuàng)新意見(jiàn)》），提出36項(xiàng)重要改革措施。為保障有關(guān)改革措施落實(shí)于法有據(jù)，食品藥品監(jiān)管總局就目前急需修改《藥品管理法》的內(nèi)容進(jìn)行認(rèn)真研究，形成《中華人民共和國(guó)藥品管理法修正案》（草案征求意見(jiàn)稿），現(xiàn)就有關(guān)情況說(shuō)明如下：
一、修改的總體思路
法律的修改有兩種形式：一是法律修正，即對(duì)法律部分條款進(jìn)行修改；二是法律修訂，即對(duì)法律進(jìn)行全面修改?！端幤饭芾矸ā沸抻啽涣袨槭萌珖?guó)人大常委會(huì)五年立法規(guī)劃。2013年12月，總局正式啟動(dòng)《藥品管理法》修訂工作。目前，已經(jīng)形成《藥品管理法》修訂草案第四稿，將按程序盡快向社會(huì)公開征求意見(jiàn)。
2016年，總局開始著手《創(chuàng)新意見(jiàn)》起草，并就《創(chuàng)新意見(jiàn)》中涉及法律修改或者需要取得相應(yīng)授權(quán)的改革措施同步開展研究。
本次《藥品管理法》的修改，采取修正案方式，緊緊圍繞《創(chuàng)新意見(jiàn)》，根據(jù)實(shí)踐基礎(chǔ)，結(jié)合實(shí)際需要，對(duì)《創(chuàng)新意見(jiàn)》提出的改革措施進(jìn)行梳理，堅(jiān)持“能不改則不改、能少改則少改”的總體思路，確?！秳?chuàng)新意見(jiàn)》各項(xiàng)改革措施盡快順利實(shí)施。
為落實(shí)國(guó)務(wù)院“放管服”要求，食品藥品監(jiān)管總局已按程序報(bào)請(qǐng)取消藥物臨床試驗(yàn)機(jī)構(gòu)資格認(rèn)定、藥品生產(chǎn)質(zhì)量管理規(guī)范認(rèn)證和藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范認(rèn)證3項(xiàng)行政審批事項(xiàng)。為避免《藥品管理法》在短時(shí)期內(nèi)兩次修改，本次修改時(shí)將上述內(nèi)容一并進(jìn)行。
二、修改的主要內(nèi)容
修正案草案征求意見(jiàn)稿對(duì)現(xiàn)行《藥品管理法》增加6條，修改9條，刪去2條。主要修改內(nèi)容包括：
（一）全面實(shí)施藥品上市許可持有人制度。草案征求意見(jiàn)稿總結(jié)了藥品上市許可持有人制度試點(diǎn)經(jīng)驗(yàn)，全面落實(shí)藥品上市許可持有人制度。一是在總則中增加一條，明確國(guó)家實(shí)行藥品上市許可持有人制度，藥品上市許可持有人對(duì)藥品安全、有效和質(zhì)量可控承擔(dān)法律責(zé)任（第五條）。二是在第五章“藥品管理”中增加藥品上市許可持有人的相關(guān)內(nèi)容，明確取得藥品批準(zhǔn)文號(hào)的申請(qǐng)人為藥品上市許可持有人（第三十一條），藥品上市許可持有人可以自行生產(chǎn)經(jīng)營(yíng)藥品也可以委托他人生產(chǎn)經(jīng)營(yíng)。藥品上市許可持有人對(duì)藥品臨床前研究、臨床試驗(yàn)、生產(chǎn)經(jīng)營(yíng)、不良反應(yīng)報(bào)告等承擔(dān)全部法律責(zé)任，境外藥品上市許可持有人還應(yīng)當(dāng)指定代理人共同承擔(dān)法律責(zé)任（第三十二條）；藥品上市許可持有人為藥品再評(píng)價(jià)的責(zé)任主體（第三十四條）。三是在相關(guān)法律義務(wù)和法律責(zé)任條款中相應(yīng)增加藥品上市許可持有人（第三十四條、第五十二條、第五十四條、第七十條、第七十一條、第七十九條），或者將藥品生產(chǎn)企業(yè)改成藥品上市許可持有人（第五十五條、第五十六條、第五十八條、第八十九條、第九十條、第九十二條），與現(xiàn)行《藥品管理法》條款相銜接。
（二）落實(shí)行政審批制度改革要求。將臨床試驗(yàn)機(jī)構(gòu)由認(rèn)證改為備案，藥物臨床試驗(yàn)審批由明示許可改為默示許可，生物等效性試驗(yàn)實(shí)行備案管理（第二十九條）。取消藥品生產(chǎn)質(zhì)量管理規(guī)范認(rèn)證、藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范認(rèn)證制度（第十條、第十六條）。將原料藥和輔料修改為與藥品一并審批（第三十一條）。
（三）增加建立職業(yè)化藥品檢查員制度。在第八章“藥品監(jiān)督”中增加一條，規(guī)定國(guó)家建立藥品職業(yè)化檢查員制度，檢查員應(yīng)當(dāng)具備藥品法律法規(guī)和專業(yè)知識(shí)，考核合格后方可從事檢查工作；國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)藥品職業(yè)化檢查員實(shí)施分級(jí)管理，建立考核、薪酬、晉升等激勵(lì)約束機(jī)制（第六十四條）。
（四）落實(shí)處罰到人要求。在根據(jù)義務(wù)條款修改相應(yīng)完善藥物非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)、合同研究組織、藥品上市許可持有人法律責(zé)任（第七十九條、第九十四條）的同時(shí)，增加處罰到人的具體條款。對(duì)存在資料和數(shù)據(jù)造假和被吊銷許可證的單位及其直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員，十年內(nèi)行業(yè)禁入；因藥品安全犯罪被判處有期徒刑以上刑罰的人員，終身不得從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、進(jìn)出口活動(dòng)（第九十四條）。藥品上市許可持有人、研制單位、生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)故意實(shí)施違法行為或存在重大過(guò)失，或者違法行為情節(jié)嚴(yán)重、性質(zhì)惡劣或造成嚴(yán)重后果以及其他嚴(yán)重不良社會(huì)影響的，對(duì)單位直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員處以其上一年度從本單位取得的收入百分之三十以上一倍以下罰款（第九十六條）。
為確?！秳?chuàng)新意見(jiàn)》相關(guān)改革措施盡快實(shí)施，此次《藥品管理法》只是局部修改，對(duì)法律篇章結(jié)構(gòu)調(diào)整、藥品定義和分類、藥品全鏈條和全生命周期管理、監(jiān)管措施細(xì)化等暫未涉及；專利鏈接、專利期補(bǔ)償?shù)忍剿骱驮圏c(diǎn)工作暫不列入，將按程序報(bào)請(qǐng)全國(guó)人大常委會(huì)授權(quán)。下一步，食品藥品監(jiān)管總局將加快《藥品管理法》全面修訂工作進(jìn)程，上述內(nèi)容將在修訂草案中予以充分體現(xiàn)，力爭(zhēng)年底前將修訂草案報(bào)送國(guó)務(wù)院法制辦。
附件2
《中華人民共和國(guó)藥品管理法》修正案
（草案征求意見(jiàn)稿）
為深化審評(píng)審批制度改革，鼓勵(lì)藥品創(chuàng)新，保障公眾用藥權(quán)益，對(duì)《中華人民共和國(guó)藥品管理法》作如下修改：
一、增加一條，作為第五條：“國(guó)家實(shí)行藥品上市許可持有人制度，藥品上市許可持有人對(duì)藥品安全、有效和質(zhì)量可控承擔(dān)法律責(zé)任?！?
二、將第九條改為第十條，并將第一款修改為“藥品生產(chǎn)應(yīng)當(dāng)符合國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》，建立健全質(zhì)量管理體系，保證生產(chǎn)過(guò)程持續(xù)合規(guī)?！?
三、將第十條改為第十一條，并刪去第一款中的“藥品生產(chǎn)企業(yè)”。
四、刪去第十三條。
五、將第十六條第一款修改為“藥品經(jīng)營(yíng)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品?！?
六、將第二十九條修改為“研制新藥，必須經(jīng)倫理委員會(huì)審查同意后，按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)自受理新藥臨床試驗(yàn)申請(qǐng)之日起六十個(gè)工作日內(nèi)決定是否同意開展臨床試驗(yàn)；逾期未通知的，申請(qǐng)人可以開展臨床試驗(yàn)。
“開展新藥臨床試驗(yàn)，應(yīng)當(dāng)在具備相應(yīng)條件的臨床試驗(yàn)機(jī)構(gòu)進(jìn)行。藥物臨床試驗(yàn)機(jī)構(gòu)實(shí)行備案管理，具體辦法由國(guó)務(wù)院藥品監(jiān)督管理部門、國(guó)務(wù)院衛(wèi)生行政部門共同制定。
“研制與已上市原研藥品或者參比藥品安全、質(zhì)量和療效一致的藥品，應(yīng)當(dāng)按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定開展藥學(xué)、藥理、毒理等研究；需要開展生物等效性試驗(yàn)的，應(yīng)當(dāng)報(bào)國(guó)務(wù)院藥品監(jiān)督管理部門備案。”
七、將三十一條修改為：“生產(chǎn)藥品，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。實(shí)施批準(zhǔn)文號(hào)管理的中藥材、中藥飲片品種目錄由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門制定。
“取得藥品批準(zhǔn)文號(hào)的申請(qǐng)人，為藥品上市許可持有人。藥品上市許可持有人自行生產(chǎn)藥品的，應(yīng)當(dāng)取得藥品生產(chǎn)許可。藥品上市許可持有人自行經(jīng)營(yíng)藥品的，應(yīng)當(dāng)具備本法規(guī)定的藥品經(jīng)營(yíng)的條件；委托具備相應(yīng)資質(zhì)的藥品生產(chǎn)經(jīng)營(yíng)企業(yè)生產(chǎn)經(jīng)營(yíng)其藥品的，應(yīng)當(dāng)與受托企業(yè)簽訂委托協(xié)議，明確雙方權(quán)利、義務(wù)和責(zé)任，保證受托企業(yè)的生產(chǎn)經(jīng)營(yíng)行為符合本法規(guī)定的要求。
“生產(chǎn)藥品所需的原料藥、輔料，由國(guó)務(wù)院藥品監(jiān)督管理部門審批藥品時(shí)一并審批?！?
八、增加一條，作為第三十二條：“藥品上市許可持有人應(yīng)當(dāng)建立藥品質(zhì)量保證體系，具備質(zhì)量管理、風(fēng)險(xiǎn)防控、持續(xù)研究、責(zé)任賠償?shù)饶芰Γ瑢?duì)藥品臨床前研究、臨床試驗(yàn)、生產(chǎn)經(jīng)營(yíng)、不良反應(yīng)報(bào)告等承擔(dān)全部法律責(zé)任。
“境外藥品上市許可持有人，還應(yīng)當(dāng)指定境內(nèi)具備相應(yīng)質(zhì)量管理、風(fēng)險(xiǎn)防控、責(zé)任賠償能力的企業(yè)法人，履行本法規(guī)定的境內(nèi)上市藥品管理義務(wù)，共同承擔(dān)法律責(zé)任。
“變更藥品上市許可持有人應(yīng)當(dāng)符合本法規(guī)定的條件，并經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)?！?
九、將第三十三條改為第三十四條，修改為“國(guó)務(wù)院藥品監(jiān)督管理部門組織藥學(xué)、醫(yī)學(xué)和其他技術(shù)人員，對(duì)新藥進(jìn)行審評(píng)。
“有下列情形之一的，藥品上市許可持有人應(yīng)當(dāng)主動(dòng)開展藥品再評(píng)價(jià)：
“（一）根據(jù)科學(xué)研究的發(fā)展，對(duì)藥品的安全性、有效性有認(rèn)識(shí)上的改變；
“（二）發(fā)現(xiàn)新的潛在風(fēng)險(xiǎn)或者風(fēng)險(xiǎn)改變的；
“（三）通過(guò)藥品不良反應(yīng)及其他與用藥有關(guān)的有害反應(yīng)監(jiān)測(cè)、風(fēng)險(xiǎn)評(píng)估等發(fā)現(xiàn)藥品可能風(fēng)險(xiǎn)大于獲益的。
“藥品上市許可持有人未按規(guī)定履行藥品再評(píng)價(jià)義務(wù)的，國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)責(zé)令藥品上市許可持有人開展再評(píng)價(jià)。必要時(shí)，國(guó)務(wù)院藥品監(jiān)督管理部門可以直接組織開展藥品再評(píng)價(jià)?！?
十、將第四十八條改為第四十九條，并將第二款第五項(xiàng)修改為“使用依照本法需要一并審批而未審批的原料藥生產(chǎn)的；”
十一、增加一條，作為第六十四條“國(guó)家建立藥品職業(yè)化檢查員制度。檢查員應(yīng)當(dāng)具備藥品法律法規(guī)和專業(yè)知識(shí)，考核合格后方可從事檢查工作。
“國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)藥品職業(yè)化檢查員實(shí)施分級(jí)管理，建立考核、薪酬、晉升等激勵(lì)約束機(jī)制。”
十二、刪去第六十七條。
十三、將第七十八條改為第七十九條，修改為“藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、藥物非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)和合同研究組織未按照規(guī)定實(shí)施《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》、藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范的，給予警告，責(zé)令限期改正；逾期不改正的，責(zé)令停產(chǎn)、停業(yè)整頓，并處五千元以上兩萬(wàn)元以下的罰款；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》和《藥品經(jīng)營(yíng)許可證》,藥物非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)、合同研究組織五年內(nèi)不得開展藥物非臨床安全性評(píng)價(jià)研究、藥物臨床試驗(yàn)相關(guān)工作。構(gòu)成犯罪的，依法追究刑事責(zé)任。
“藥物臨床試驗(yàn)機(jī)構(gòu)未按照本法第二十九條規(guī)定備案、開展生物等效性試驗(yàn)未按照本法第二十九條規(guī)定備案的，責(zé)令改正，給予警告，并可以處十萬(wàn)元以下罰款?！?
十四、增加一條，作為第九十四條：“藥品上市許可持有人違反本法第三十二條規(guī)定的，處十萬(wàn)元以上的罰款；情節(jié)嚴(yán)重的，責(zé)令停產(chǎn)、停業(yè)整頓，直至撤銷藥品批準(zhǔn)文號(hào)；構(gòu)成犯罪的，依法追究刑事責(zé)任?！?
十五、增加一條，作為第九十五條：“藥物非臨床安全性評(píng)價(jià)機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)、合同研究組織、藥品上市許可持有人、藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)或者醫(yī)療機(jī)構(gòu)存在資料或者數(shù)據(jù)造假違法行為，或者因違法被吊銷許可證件的，其單位直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員十年內(nèi)不得從事藥品研制、生產(chǎn)、經(jīng)營(yíng)、進(jìn)出口和使用活動(dòng)。
“因藥品安全犯罪被判處有期徒刑以上刑罰的人員，終身不得從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、進(jìn)出口和使用活動(dòng)?！?
十六、增加一條，作為第九十六條：“藥物非臨床安全性評(píng)價(jià)機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)、合同研究組織、藥品上市許可持有人、藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)違反本法規(guī)定，除依照本章前述規(guī)定對(duì)單位予以處罰外，有下列情形之一的，對(duì)單位直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員處以其上一年度從本單位取得的收入百分之三十以上一倍以下罰款：
“（一）故意實(shí)施違法行為或者存在重大過(guò)失；
“（二）違法行為情節(jié)嚴(yán)重、性質(zhì)惡劣；
“（三）違法行為造成嚴(yán)重后果或者其他嚴(yán)重不良社會(huì)影響?！?
十七、將第九十三條改為第九十七條，并刪去第一項(xiàng)，將第三項(xiàng)修改為“對(duì)不具備臨床試驗(yàn)條件或者法定條件而批準(zhǔn)進(jìn)行臨床試驗(yàn)、發(fā)給藥品批準(zhǔn)文號(hào)的?！?
十八、在第三十四條、第五十二條第二款、第七十條第一款、第七十一條中增加“藥品上市許可持有人”；在第五十四條第二款、第七十九條中增加“上市許可持有人”；將第五十五條、第五十六條、第五十八條、第八十九條、第九十條、第九十二條中的“生產(chǎn)企業(yè)”修改為“上市許可持有人”。
本修正案自公布之日起施行。
《中華人民共和國(guó)藥品管理法》根據(jù)本決定作相應(yīng)修改，重新公布。
附件3
中華人民共和國(guó)藥品管理法
修正案草案花臉稿
（2017年10月19日）
目錄
第一章 總則
第二章 藥品生產(chǎn)企業(yè)管理
第三章 藥品經(jīng)營(yíng)企業(yè)管理
第四章 醫(yī)療機(jī)構(gòu)的藥劑管理
第五章 藥品管理
第六章 藥品包裝的管理
第七章 藥品價(jià)格和廣告的管理
第八章 藥品監(jiān)督
第九章 法律責(zé)任
第十章 附則
第一章 總則
第一條為加強(qiáng)藥品監(jiān)督管理，保證藥品質(zhì)量，保障人體用藥安全，維護(hù)人民身體健康和用藥的合法權(quán)益，特制定本法。
第二條在中華人民共和國(guó)境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守本法。
第三條國(guó)家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預(yù)防、醫(yī)療和保健中的作用。
國(guó)家保護(hù)野生藥材資源，鼓勵(lì)培育中藥材。
第四條國(guó)家鼓勵(lì)研究和創(chuàng)制新藥，保護(hù)公民、法人和其他組織研究、開發(fā)新藥的合法權(quán)益。
第五條國(guó)家實(shí)行藥品上市許可持有人制度，藥品上市許可持有人對(duì)藥品安全、有效和質(zhì)量可控承擔(dān)法律責(zé)任。
第六條國(guó)務(wù)院藥品監(jiān)督管理部門主管全國(guó)藥品監(jiān)督管理工作。國(guó)務(wù)院有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。
省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。省、自治區(qū)、直轄市人民政府有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。
國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)配合國(guó)務(wù)院經(jīng)濟(jì)綜合主管部門，執(zhí)行國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策。
第七條藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。
第二章 藥品生產(chǎn)企業(yè)管理
第八條開辦藥品生產(chǎn)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品生產(chǎn)許可證》。無(wú)《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。
《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。
藥品監(jiān)督管理部門批準(zhǔn)開辦藥品生產(chǎn)企業(yè)，除依據(jù)本法第九條規(guī)定的條件外，還應(yīng)當(dāng)符合國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。
第九條開辦藥品生產(chǎn)企業(yè)，必須具備以下條件:
（一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；
（二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；
（三）具有能對(duì)所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；
（四）具有保證藥品質(zhì)量的規(guī)章制度。
第十條藥品生產(chǎn)企業(yè)必須按照應(yīng)當(dāng)符合國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)，藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。建立健全質(zhì)量管理體系，保證生產(chǎn)過(guò)程持續(xù)合規(guī)。
《藥品生產(chǎn)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定。
第十一條除中藥飲片的炮制外，藥品必須按照國(guó)家藥品標(biāo)準(zhǔn)和國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。
中藥飲片必須按照國(guó)家藥品標(biāo)準(zhǔn)炮制；國(guó)家藥品標(biāo)準(zhǔn)沒(méi)有規(guī)定的，必須按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范炮制。省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范應(yīng)當(dāng)報(bào)國(guó)務(wù)院藥品監(jiān)督管理部門備案。
第十二條生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。
第十三條藥品生產(chǎn)企業(yè)必須對(duì)其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗(yàn)；不符合國(guó)家藥品標(biāo)準(zhǔn)或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。
第十三條 經(jīng)省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。
第三章藥品經(jīng)營(yíng)企業(yè)管理
第十四條開辦藥品批發(fā)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)許可證》；開辦藥品零售企業(yè)，須經(jīng)企業(yè)所在地縣級(jí)以上地方藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)許可證》。無(wú)《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。
《藥品經(jīng)營(yíng)許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營(yíng)范圍，到期重新審查發(fā)證。
藥品監(jiān)督管理部門批準(zhǔn)開辦藥品經(jīng)營(yíng)企業(yè)，除依據(jù)本法第十五條規(guī)定的條件外，還應(yīng)當(dāng)遵循合理布局和方便群眾購(gòu)藥的原則。
第十五條開辦藥品經(jīng)營(yíng)企業(yè)必須具備以下條件:
（一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員；
（二）具有與所經(jīng)營(yíng)藥品相適應(yīng)的營(yíng)業(yè)場(chǎng)所、設(shè)備、倉(cāng)儲(chǔ)設(shè)施、衛(wèi)生環(huán)境；
（三）具有與所經(jīng)營(yíng)藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；
（四）具有保證所經(jīng)營(yíng)藥品質(zhì)量的規(guī)章制度。
第十六條藥品經(jīng)營(yíng)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品。藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品經(jīng)營(yíng)企業(yè)是否符合《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。
《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定。
第十七條藥品經(jīng)營(yíng)企業(yè)購(gòu)進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)。
第十八條藥品經(jīng)營(yíng)企業(yè)購(gòu)銷藥品，必須有真實(shí)完整的購(gòu)銷記錄。購(gòu)銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購(gòu)（銷）貨單位、購(gòu)（銷）貨數(shù)量、購(gòu)銷價(jià)格、購(gòu)（銷）貨日期及國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。
第十九條藥品經(jīng)營(yíng)企業(yè)銷售藥品必須準(zhǔn)確無(wú)誤，并正確說(shuō)明用法、用量和注意事項(xiàng)；調(diào)配處方必須經(jīng)過(guò)核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
藥品經(jīng)營(yíng)企業(yè)銷售中藥材，必須標(biāo)明產(chǎn)地。
第二十條藥品經(jīng)營(yíng)企業(yè)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。
藥品入庫(kù)和出庫(kù)必須執(zhí)行檢查制度。
第二十一條城鄉(xiāng)集市貿(mào)易市場(chǎng)可以出售中藥材，國(guó)務(wù)院另有規(guī)定的除外。
城鄉(xiāng)集市貿(mào)易市場(chǎng)不得出售中藥材以外的藥品，但持有《藥品經(jīng)營(yíng)許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場(chǎng)設(shè)點(diǎn)出售中藥材以外的藥品。具體辦法由國(guó)務(wù)院規(guī)定。
第四章 醫(yī)療機(jī)構(gòu)的藥劑管理
第二十二條醫(yī)療機(jī)構(gòu)必須配備依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員。非藥學(xué)技術(shù)人員不得直接從事藥劑技術(shù)工作。
第二十三條醫(yī)療機(jī)構(gòu)配制制劑，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。無(wú)《醫(yī)療機(jī)構(gòu)制劑許可證》的，不得配制制劑。
《醫(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。
第二十四條醫(yī)療機(jī)構(gòu)配制制劑，必須具有能夠保證制劑質(zhì)量的設(shè)施、管理制度、檢驗(yàn)儀器和衛(wèi)生條件。
第二十五條醫(yī)療機(jī)構(gòu)配制的制劑，應(yīng)當(dāng)是本單位臨床需要而市場(chǎng)上沒(méi)有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)后方可配制。配制的制劑必須按照規(guī)定進(jìn)行質(zhì)量檢驗(yàn)；合格的，憑醫(yī)師處方在本醫(yī)療機(jī)構(gòu)使用。特殊情況下，經(jīng)國(guó)務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門批準(zhǔn)，醫(yī)療機(jī)構(gòu)配制的制劑可以在指定的醫(yī)療機(jī)構(gòu)之間調(diào)劑使用。
醫(yī)療機(jī)構(gòu)配制的制劑，不得在市場(chǎng)銷售。
第二十六條醫(yī)療機(jī)構(gòu)購(gòu)進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)和使用。
第二十七條醫(yī)療機(jī)構(gòu)的藥劑人員調(diào)配處方，必須經(jīng)過(guò)核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
第二十八條醫(yī)療機(jī)構(gòu)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。
第五章 藥品管理
第二十九條研制新藥，必須經(jīng)倫理委員會(huì)審查同意后，按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)自受理新藥臨床試驗(yàn)申請(qǐng)之日起六十個(gè)工作日內(nèi)決定是否同意開展臨床試驗(yàn)；逾期未通知的，申請(qǐng)人可以開展臨床試驗(yàn)。
開展新藥臨床試驗(yàn)，應(yīng)當(dāng)在具備相應(yīng)條件的臨床試驗(yàn)機(jī)構(gòu)進(jìn)行。藥物臨床試驗(yàn)機(jī)構(gòu)資格的認(rèn)定辦法實(shí)行備案管理，具體辦法由國(guó)務(wù)院藥品監(jiān)督管理部門、國(guó)務(wù)院衛(wèi)生行政部門共同制定。
完成臨床試驗(yàn)并通過(guò)審批的新藥，由國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。
研制與已上市原研藥品或者參比藥品安全、質(zhì)量和療效一致的藥品，應(yīng)當(dāng)按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定開展藥學(xué)、藥理、毒理等研究；需要開展生物等效性試驗(yàn)的，應(yīng)當(dāng)報(bào)國(guó)務(wù)院藥品監(jiān)督管理部門備案。
第三十條藥物的非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)和臨床試驗(yàn)機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。
藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范由國(guó)務(wù)院確定的部門制定。
第三十一條生產(chǎn)新藥或者已有國(guó)家標(biāo)準(zhǔn)的藥品的，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。實(shí)施批準(zhǔn)文號(hào)管理的中藥材、中藥飲片品種目錄由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門制定。
藥品生產(chǎn)企業(yè)在取得藥品批準(zhǔn)文號(hào)后，方可生產(chǎn)該藥品。
取得藥品批準(zhǔn)文號(hào)的申請(qǐng)人，為藥品上市許可持有人。藥品上市許可持有人自行生產(chǎn)藥品的，應(yīng)當(dāng)取得藥品生產(chǎn)許可。藥品上市許可持有人自行經(jīng)營(yíng)藥品的，應(yīng)當(dāng)具備本法規(guī)定的藥品經(jīng)營(yíng)的條件；委托具備相應(yīng)資質(zhì)的藥品生產(chǎn)經(jīng)營(yíng)企業(yè)生產(chǎn)經(jīng)營(yíng)其藥品的，應(yīng)當(dāng)與受托企業(yè)簽訂委托協(xié)議，明確雙方權(quán)利、義務(wù)和責(zé)任，保證受托企業(yè)的生產(chǎn)經(jīng)營(yíng)行為符合本法規(guī)定的要求。
生產(chǎn)藥品所需的原料藥、輔料，由國(guó)務(wù)院藥品監(jiān)督管理部門審批藥品時(shí)一并審批。
第三十二條藥品上市許可持有人應(yīng)當(dāng)建立藥品質(zhì)量保證體系，具備質(zhì)量管理、風(fēng)險(xiǎn)防控、持續(xù)研究、責(zé)任賠償?shù)饶芰?，?duì)藥品臨床前研究、臨床試驗(yàn)、生產(chǎn)經(jīng)營(yíng)、不良反應(yīng)報(bào)告等承擔(dān)全部法律責(zé)任。
境外藥品上市許可持有人，還應(yīng)當(dāng)指定境內(nèi)具備相應(yīng)質(zhì)量管理、風(fēng)險(xiǎn)防控、責(zé)任賠償能力的企業(yè)法人，履行本法規(guī)定的境內(nèi)上市藥品管理義務(wù)，共同承擔(dān)法律責(zé)任。
變更藥品上市許可持有人應(yīng)當(dāng)符合本法規(guī)定的條件，并經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)。
第三十三條藥品必須符合國(guó)家藥品標(biāo)準(zhǔn)。中藥飲片依照本法第十一條第二款的規(guī)定執(zhí)行。
國(guó)務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國(guó)藥典》和藥品標(biāo)準(zhǔn)為國(guó)家藥品標(biāo)準(zhǔn)。
國(guó)務(wù)院藥品監(jiān)督管理部門組織藥典委員會(huì)，負(fù)責(zé)國(guó)家藥品標(biāo)準(zhǔn)的制定和修訂。
國(guó)務(wù)院藥品監(jiān)督管理部門的藥品檢驗(yàn)機(jī)構(gòu)負(fù)責(zé)標(biāo)定國(guó)家藥品標(biāo)準(zhǔn)品、對(duì)照品。
第三十四條國(guó)務(wù)院藥品監(jiān)督管理部門組織藥學(xué)、醫(yī)學(xué)和其他技術(shù)人員，對(duì)新藥進(jìn)行審評(píng)，對(duì)已經(jīng)批準(zhǔn)生產(chǎn)上市的藥品進(jìn)行再評(píng)價(jià)。
有下列情形之一的，藥品上市許可持有人應(yīng)當(dāng)主動(dòng)開展藥品再評(píng)價(jià)：
（一）根據(jù)科學(xué)研究的發(fā)展，對(duì)藥品的安全性、有效性有認(rèn)識(shí)上的改變；
（二）發(fā)現(xiàn)新的潛在風(fēng)險(xiǎn)或者風(fēng)險(xiǎn)改變的；
（三）通過(guò)藥品不良反應(yīng)及其他與用藥有關(guān)的有害反應(yīng)監(jiān)測(cè)、風(fēng)險(xiǎn)評(píng)估等發(fā)現(xiàn)藥品可能風(fēng)險(xiǎn)大于獲益的。
藥品上市許可持有人未按規(guī)定履行藥品再評(píng)價(jià)義務(wù)的，國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)責(zé)令藥品上市許可持有人開展再評(píng)價(jià)。必要時(shí)，國(guó)務(wù)院藥品監(jiān)督管理部門可以直接組織開展藥品再評(píng)價(jià)。
第三十五條藥品上市許可持有人、藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營(yíng)資格的企業(yè)購(gòu)進(jìn)藥品；但是，購(gòu)進(jìn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。
第三十六條國(guó)家對(duì)麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。管理辦法由國(guó)務(wù)院制定。
第三十七條國(guó)家實(shí)行中藥品種保護(hù)制度。具體辦法由國(guó)務(wù)院制定。
第三十八條國(guó)家對(duì)藥品實(shí)行處方藥與非處方藥分類管理制度。具體辦法由國(guó)務(wù)院制定。
第三十九條禁止進(jìn)口療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品。
第四十條藥品進(jìn)口，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊(cè)證書。醫(yī)療單位臨床急需或者個(gè)人自用進(jìn)口的少量藥品，按照國(guó)家有關(guān)規(guī)定辦理進(jìn)口手續(xù)。
第四十一條藥品必須從允許藥品進(jìn)口的口岸進(jìn)口，并由進(jìn)口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。海關(guān)憑藥品監(jiān)督管理部門出具的《進(jìn)口藥品通關(guān)單》放行。無(wú)《進(jìn)口藥品通關(guān)單》的，海關(guān)不得放行。
口岸所在地藥品監(jiān)督管理部門應(yīng)當(dāng)通知藥品檢驗(yàn)機(jī)構(gòu)按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定對(duì)進(jìn)口藥品進(jìn)行抽查檢驗(yàn)，并依照本法第四十二條第二款的規(guī)定收取檢驗(yàn)費(fèi)。
允許藥品進(jìn)口的口岸由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同海關(guān)總署提出，報(bào)國(guó)務(wù)院批準(zhǔn)。
第四十二條國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)下列藥品在銷售前或者進(jìn)口時(shí)，指定藥品檢驗(yàn)機(jī)構(gòu)進(jìn)行檢驗(yàn)；檢驗(yàn)不合格的，不得銷售或者進(jìn)口:
（一）國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的生物制品；
（二）首次在中國(guó)銷售的藥品；
（三）國(guó)務(wù)院規(guī)定的其他藥品。
前款所列藥品的檢驗(yàn)費(fèi)項(xiàng)目和收費(fèi)標(biāo)準(zhǔn)由國(guó)務(wù)院財(cái)政部門會(huì)同國(guó)務(wù)院價(jià)格主管部門核定并公告。檢驗(yàn)費(fèi)收繳辦法由國(guó)務(wù)院財(cái)政部門會(huì)同國(guó)務(wù)院藥品監(jiān)督管理部門制定。
第四十三條國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)已經(jīng)批準(zhǔn)生產(chǎn)或者進(jìn)口的藥品，應(yīng)當(dāng)組織調(diào)查；對(duì)療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品，應(yīng)當(dāng)撤銷批準(zhǔn)文號(hào)或者進(jìn)口藥品注冊(cè)證書。
已被撤銷批準(zhǔn)文號(hào)或者進(jìn)口藥品注冊(cè)證書的藥品，不得生產(chǎn)或者進(jìn)口、銷售和使用；已經(jīng)生產(chǎn)或者進(jìn)口的，由當(dāng)?shù)厮幤繁O(jiān)督管理部門監(jiān)督銷毀或者處理。
第四十四條國(guó)家實(shí)行藥品儲(chǔ)備制度。
國(guó)內(nèi)發(fā)生重大災(zāi)情、疫情及其他突發(fā)事件時(shí)，國(guó)務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。
第四十五條對(duì)國(guó)內(nèi)供應(yīng)不足的藥品，國(guó)務(wù)院有權(quán)限制或者禁止出口。
第四十六條進(jìn)口、出口麻醉藥品和國(guó)家規(guī)定范圍內(nèi)的精神藥品，必須持有國(guó)務(wù)院藥品監(jiān)督管理部門發(fā)給的《進(jìn)口準(zhǔn)許證》、《出口準(zhǔn)許證》。
第四十七條新發(fā)現(xiàn)和從國(guó)外引種的藥材，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門審核批準(zhǔn)后，方可銷售。
第四十八條地區(qū)性民間習(xí)用藥材的管理辦法，由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門制定。
第四十九條禁止生產(chǎn)（包括配制，下同）、銷售假藥。
有下列情形之一的，為假藥:
（一）藥品所含成份與國(guó)家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的；
（二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。
有下列情形之一的藥品，按假藥論處:
（一）國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的；
（二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷售的；
（三）變質(zhì)的；
（四）被污染的；
用戶評(píng)價(jià)
5.187.70.1942020-12-13 17:15:30
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