【導(dǎo)讀】第二十次會(huì)議于2020年2月28日修訂通過，現(xiàn)將修訂后的《中華人民共和國藥品管理法》公布，自2020年12月1日起施行。用藥的合法權(quán)益，特制定本法。者個(gè)人，必須遵守本法。第三條國家發(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。國家保護(hù)野生藥材資源，鼓勵(lì)培育中藥材。第五條國務(wù)院藥品監(jiān)督管理部門主管全國藥品監(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。

　　

【正文】 roduce medicine only after obtaining the registered document of approval. 第三十二條 藥品必須符合國家藥品標(biāo)準(zhǔn)。中藥飲片依照本法第十條第二款的規(guī)定執(zhí)行。 Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in readytouse forms. 國務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國藥典》和藥品標(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)。 14 The Pharmacopoeia of the People39。39。s Republic of China and the pharmaceutical standards promulgated by the pharmaceutical supervisory and administrative department under the State Council shall be the State pharmaceutical standards. 國務(wù)院藥品監(jiān)督管理部門組織藥典委員會(huì)，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂。 The Pharmacopoeia Committee anized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards. 國務(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)定國家藥品標(biāo)準(zhǔn)品、對照品。 The pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals. 第三十三條 國務(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，對新藥進(jìn)行審評，對已經(jīng)批準(zhǔn)生產(chǎn)的藥品進(jìn)行再評價(jià)。 Article 33 The pharmaceutical supervisory and administrative department under the State Council may anize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production. 第三十四條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。 Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical anizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval. 第三十五條 國家 對麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。管理辦法由國務(wù)院制定。 Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control. 第三十六條 國家實(shí)行中藥品種 保護(hù)制度。具體辦法由國務(wù)院制定。 Article 36 The State Council shall formulate detailed measures to carry out a 15 protection system for the categorization of traditional Chinese medicines. 第三十七條 國家對藥品實(shí)行處方藥與非處方藥分類管理制度。具體辦法由國務(wù)院制定。 Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and nonprescription pharmaceuticals. 第三十八條 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。 Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people39。39。s health shall be prohibited. 第三十九條 藥品進(jìn)口，須經(jīng)國務(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)口藥品注冊證書。 Article 39 The import of medicines must go through examinations anized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import. 醫(yī)療單位臨床急需或者個(gè)人自用進(jìn)口的少量藥品，按照國家有關(guān)規(guī)定辦理進(jìn)口手續(xù)。 Medicines to be imported in small quantities for urgent clinical needs by medical anizations or for personal use shall go through import formalities according to relevant regulations of the State. 第四十條 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《進(jìn)口藥品通關(guān)單》的，海關(guān)不得放行。 Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs. 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)按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定對進(jìn)口藥品進(jìn)行抽查檢驗(yàn)，并依照本法第四十一條第 二款的規(guī)定收取檢驗(yàn)費(fèi)。 16 The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law. 允許藥品進(jìn)口的口岸由國務(wù)院藥品監(jiān)督管理部門會(huì)同海關(guān)總署提出，報(bào)國務(wù)院批準(zhǔn)。 The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval. 第四十一條 國務(wù)院藥品監(jiān)督管理部門對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： Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported. （一）國務(wù)院藥品監(jiān)督管理部門規(guī)定的生物制品； (1) Bioproducts prescribed by the pharmaceutical supervisory and administrative department of the State Council. （二）首次在中 國銷售的藥品； (2) Pharmaceuticals to be sold for the first time in China. （三）國務(wù)院規(guī)定的其他藥品。 (3) Other pharmaceuticals prescribed by the State Council. 前款所列藥品的檢驗(yàn)費(fèi)項(xiàng)目和收費(fèi)標(biāo)準(zhǔn)由國務(wù)院財(cái)政部門會(huì)同國務(wù)院價(jià)格主管部門核定并公告。檢驗(yàn)費(fèi)收繳辦法由國務(wù)院財(cái)政部門會(huì)同國務(wù)院藥品監(jiān)督管理部門制定。 The inspection fee and charge standards for the abovementioned pharmaceuticals shall be jointly checked, ratified and promulgated by t