【正文】 1 Pharmaceutical Administration Law of The People39。s Republic of China 中華共和國(guó)主席令第 45號(hào) Order of the President of the People39。s Republic of China 《中華人民共和國(guó)藥品管理法》已由中華人民共和國(guó)第九屆全國(guó)人民代表大會(huì)常務(wù)委員會(huì)第二十次會(huì)議于 2020年 2月 28日修訂通過(guò)，現(xiàn)將修訂后的《中華人民共和國(guó)藥品管理法》公布，自 2020年 12月 1日起施行。 The Pharmaceutical Administration Law of the People39。s Republic of China has been revised at the Twentieth Meeting of the Standing Committee of the Ninth National People39。s Congress on February 28, 2020, and now promulgated the revised edition of the Pharmaceutical Administration Law of the People39。s Republic of China, and shall enter into force as of December 1, 2020. 中華人民共和國(guó)主席 江澤民 Jiang Zemin, President of the People39。s Republic of China 2020年 2月 28日 February 28, 2020 中華人民共和國(guó)藥品管理法 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(yíng)企業(yè)管理 Chapter III Administration of Pharmaceutical Trading Enterprises 第四章 醫(yī)療機(jī)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(jià)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(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。 Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people. 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。 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。39。s Republic of China. 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。 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(guó)家保護(hù)野生藥材資源，鼓勵(lì)培育中藥材。 The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops. 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(kāi)發(fā)新藥的合法權(quán)益。 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(guó)務(wù)院藥品監(jiān)督管理部門(mén)主管全國(guó)藥品監(jiān)督管 理工作。國(guó)務(wù)院有關(guān)部門(mén)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。 Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions. 省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)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(mén)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。 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions. 國(guó)務(wù)院藥品監(jiān)督管理部門(mén)應(yīng)當(dāng)配合國(guó)務(wù)院經(jīng)濟(jì)綜合主管部門(mén)，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。 The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State. 第六條 藥品監(jiān)督管理部門(mén)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。 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(kāi)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(mén)批準(zhǔn)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(mén)辦理登記注冊(cè)。無(wú)《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。 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(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。 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(mén)批準(zhǔn)開(kāi)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(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)。 The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulate