【導讀】第二十次會議于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。用藥的合法權益，特制定本法。者個人，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)揮其在預防、醫(yī)療和保健中的作用。國家保護野生藥材資源，鼓勵培育中藥材。第五條國務院藥品監(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部門在各自的職責范圍內負責與藥品有關的監(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準。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》和藥品標準為國家藥品標準。 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. 國務院藥品監(jiān)督管理部門組織藥典委員會，負責國家藥品標準的制定和修訂。 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. 國務院藥品監(jiān)督管理部門的藥品檢驗機構負責標定國家藥品標準品、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 國務院藥品監(jiān)督管理部門組織藥學、醫(yī)學和其他技術人員，對新藥進行審評，對已經批準生產的藥品進行再評價。 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 藥品生產企業(yè)、藥品經營企業(yè)、醫(yī)療機構必須從具有藥品生產、經營資格的企業(yè)購進藥品；但是，購進沒有實施批準文號管理的中藥材除外。 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，實行特殊管理。管理辦法由國務院制定。 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 國家實行中藥品種 保護制度。具體辦法由國務院制定。 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 國家對藥品實行處方藥與非處方藥分類管理制度。具體辦法由國務院制定。 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 禁止進口療效不確、不良反應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 藥品進口，須經國務院藥品監(jiān)督管理部門組織審查，經審查確認符合質量標準、安全有效的，方可批準進口，并發(fā)給進口藥品注冊證書。 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人自用進口的少量藥品，按照國家有關規(guī)定辦理進口手續(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口的口岸進口，并由進口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。海關憑藥品監(jiān)督管理部門出具的《進口藥品通關單》放行。無《進口藥品通關單》的，海關不得放行。 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)督管理部門應當通知藥品檢驗機構按照國務院藥品監(jiān)督管理部門的規(guī)定對進口藥品進行抽查檢驗，并依照本法第四十一條第 二款的規(guī)定收取檢驗費。 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. 允許藥品進口的口岸由國務院藥品監(jiān)督管理部門會同海關總署提出，報國務院批準。 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 國務院藥品監(jiān)督管理部門對下列藥品在銷售前或者進口時，指定藥品檢驗機構進行檢驗；檢驗不合格的，不得銷售或者進口： 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費項目和收費標準由國務院財政部門會同國務院價格主管部門核定并公告。檢驗費收繳辦法由國務院財政部門會同國務院藥品監(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