【正文】 ter 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。s Republic of China, and shall enter into force as of December 1, 2020. 中華人民共和國主席 江澤民 Jiang Zemin, President of the People39。s Republic of China has been revised at the Twentieth Meeting of the Standing Committee of the Ninth National 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(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，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。 1 Pharmaceutical Administration Law of The People39。s Republic of China 中華共和國主席令第 45號(hào) Order of the President of the People39。 The Pharmaceutical Administration Law of the 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 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。 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 在中華人民共和國境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守本法。39。 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(hù)野生藥材資源，鼓勵(lì)培育中藥材。 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。 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)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(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. 國務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)配合國務(wù)院經(jīng)濟(jì)綜合主管部門，執(zhí)行國家制定的藥品行業(yè)發(fā)展規(guī)劃和 產(chǎn)業(yè)政策。 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(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辦理登記注冊(cè)。 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 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 formulated by the State to avoid the instance of a repeat establishment. 第八條 開辦藥品生產(chǎn)企業(yè)，必須具備以下條件： Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met: （一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人； (1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers. （二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境； (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced. （三）具有能對(duì)所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備； (3) It shall have a unit or petent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment. 5 （四）具有保證藥品質(zhì)量的規(guī)章制度。藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。 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(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。 Article 10 Except in the preparation of traditional Chinese medicines into readytouse 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 un