【正文】 ion, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council. 完成臨床試驗并通過審批的新藥，由國務院藥品監(jiān)督管理部門批準，發(fā)給新藥證書。特殊情況下，經(jīng)國務院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門批準，醫(yī)療機構(gòu)配制的制劑可以在指定的醫(yī)療機構(gòu)之間調(diào)劑使用。 Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council. 第四章 醫(yī)療機構(gòu)的藥劑管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第二十二條 醫(yī)療機構(gòu)必須配備依法經(jīng)過資格認定的藥學技術(shù)人員。s generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council. 第十九條 藥品經(jīng)營企業(yè)銷售藥品必須準確無誤，并正確說明用法、用量和注意事項； 調(diào)配處方必須經(jīng)過核對，對處方所列藥品不得擅自更改或者代用。 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades. 第十六條 藥品經(jīng)營企業(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營質(zhì)量管理規(guī)范》經(jīng)營藥品。 Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use. 第十二條 藥品生產(chǎn)企業(yè)必須對其生產(chǎn)的藥品進行質(zhì)量檢驗；不符合國家藥品標準或者不按照省、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。 (4) It shall have rules and regulations to ensure the quality of medicines. 第九條 藥品生產(chǎn)企業(yè)必須按照國務院藥品監(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)。省、自治區(qū)、直轄市人民政府有關(guān)部門在各自的職責范圍內(nèi)負責與藥品有關(guān)的監(jiān)督管理工作。 Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People39。s Republic of China 《中華人民共和國藥品管理法》已由中華人民共和國第九屆全國人民代表大會常務委員會第二十次會議于 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。s Congress on February 28, 2020, and now promulgated the revised edition of the Pharmaceutical Administration Law of the People39。 Article 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care. 國家保護野生藥材資源，鼓勵培育中藥材。 Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations. 第二章 藥品生產(chǎn)企業(yè)管理 Chapter II Administration of Pharmaceutical Producing Enterprises 第七條 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 4 部門批準并發(fā) 給《藥品生產(chǎn)許可證》，憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊。 The detailed implementation measures and implementation process of the Standards for Quality Control of Pharmaceutical Production shall be formulated by the pharmaceutical supervisory and administrative department under the State Council. 第十條 除中藥飲片的炮制外，藥品必須按照國家藥品標準和國務院藥品監(jiān)督管理部門批準的生產(chǎn)工藝進行生產(chǎn)，生產(chǎn)記錄必須完整準確。 Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council. 第三章 藥品經(jīng)營企業(yè)管理 Chapter III Administration of Pharmaceutical Trading Enterprises 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 7 理部門批準并發(fā)給《藥品經(jīng)營許可證》；開辦藥品零售企業(yè)，須經(jīng)企業(yè)所在 地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)給《藥品經(jīng)營許可證》，憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊。 Detailed implementation measures and procedures for the Standards for Quality Control of Pharmaceutical Trading shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council. 第十七條 藥品經(jīng)營企業(yè)購進藥品，必須建 立并執(zhí)行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規(guī)定要求的，不得購進。 When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated. 第二十條 藥品經(jīng)營企業(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。無《醫(yī)療機構(gòu)制劑許可證》的，不得配制制劑。 Article 26 When purchasing pharmaceuticals, medical anizations must formulate and implement a system of quality inspection and check the certificates and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations shall not be purchased and used. 第二十七條 醫(yī)療機構(gòu)的藥劑人員調(diào)配處方，必須經(jīng)過核對，對處方所列藥品不得擅自更改或者代用。 The quality control standard for pharmaceutical nonclinical research and the quality control standard for pharmaceutical clinical test shall be formulated by the department appointed by the State Council. 第三十一條 生產(chǎn)新藥或者已有國家標準的藥品的，須經(jīng)國務院藥品監(jiān)督管理部 門批準，并發(fā)給藥品批準文號；但是，生產(chǎn)沒有實施批準文號管理的中藥材和中藥飲片除外。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。 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。海關(guān)憑藥品監(jiān)督管理部門出具的《進口藥品通關(guān)單》放