【正文】 use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be plete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities. 中藥飲片必須按照國家藥品標準炮制；國家藥品標準沒有規(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。 Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located. The establishment shall be registered at the industry and merce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced. 《藥品生產(chǎn)許可證》應(yīng)當(dāng)標明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。 Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other anizations in the research and development of new medicine. 3 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。s Republic of China 2020年 2月 28日 February 28, 2020 中華人民共和國藥品管理法 Pharmaceutical Administration Law of the People39。 1 Pharmaceutical Administration Law of The People39。s Republic of China 目錄 Contents 第一章 總則 Chapter I General Provisions 第二章 藥品生產(chǎn)企業(yè)管理 Chapter II Administration of Pharmaceutical Producing Enterprises 第三章 藥品經(jīng)營企業(yè)管理 Chapter III Administration of Pharmaceutical Trading Enterprises 第四章 醫(yī)療機構(gòu)的藥劑管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第五章 藥品管理 Chapter V Pharmaceutical Administration 第六章 藥品包裝的管理 Chapter VI Administration of the Packaging of Pharmaceuticals 2 第七 章 藥品價格和廣告的管理 Chapter VII Administration of the Prices and Advertising of Pharmaceuticals 第八章 藥品監(jiān)督 Chapter VIII Supervision over Pharmaceuticals 第九章 法律責(zé)任 Chapter IX Legal Responsibility 第十章 附則 Chapter X Supplementary Provisions 第一章 總則 Chapter I General Provisions 第一條 為加強藥品監(jiān)督管理，保證藥品質(zhì)量，保障人體用藥安全，維護人民身體健康和用藥的合法權(quán)益，特制定本法。國務(wù)院有關(guān)部門在各自的職責(zé)范圍內(nèi)負責(zé)與藥品有關(guān)的監(jiān)督管理工作。 The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 藥品監(jiān)督管理部門批準開辦藥品生產(chǎn)企業(yè)，除依據(jù)本法第八條規(guī)定的條件外，還應(yīng)當(dāng)符合國家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。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)報國務(wù)院藥品監(jiān)督管理部門備案。 A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal. 藥品監(jiān)督管理部門批準開辦藥品經(jīng)營企業(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藥的原則。藥品管理法（ 3） Article 18 Pharmaceutical trading enterprises shall keep accurate and plete 9 records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product39。 Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs. 10 城鄉(xiāng)集市貿(mào)易市場不得出售中藥材以外的藥品，但持有《藥品經(jīng)營許可證》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)易市場設(shè) 點出售中藥材以外的藥品。 11 Article 24 Medical anizations that make medicinal preparations must have facilities, a managerial system, inspection instruments, and a sanitary environment to ensure quality. 第二十五條 醫(yī)療機構(gòu)配制的制劑，應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(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)督管理部門批準后方可配制。 Article 28 Rules for storage of pharmaceuticals shall be formulated and implemented by medical anizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals. 第五章 藥品管理 Chapter V Pharmaceutical Administration 第二十九條 研制新藥，必須按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定如實報送研制方法、質(zhì)量指標、藥理及毒理試驗結(jié)果等有關(guān)資料和樣品，經(jīng)國務(wù)院藥品監(jiān)督管理部門批準后，方可進行臨床試驗。 Pharmaceutical producing enterprises can produce 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。 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)療機構(gòu)必須從具有藥品生產(chǎn)、經(jīng)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 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people39。 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(wù)院藥品監(jiān)督管理部門會同海關(guān)總署提出，報國務(wù)院批準。 (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(wù)院財政部門會同國務(wù)院價格主管部門核定并公告。s health shall be prohibited. 第三十九條 藥品進口，須經(jīng)國務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認符合質(zhì)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。管理辦法由國務(wù)院制定。 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》和藥品標準為國家藥品標準。 Article 29 When producing a new medicine, it is necessary to submit information about the methods of product