【正文】 uality inspections on the pharmaceuticals they produce。 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 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(biāo)準(zhǔn)炮制；國家藥品標(biāo)準(zhǔn)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。藥品監(jiān)督管理部門按照規(guī)定對藥品生產(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；對認(rèn)證合格的，發(fā)給認(rèn)證證書。 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 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 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。39。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。 The Pharmaceutical Administration Law of the People39。 1 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 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(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. 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(yù)防、醫(yī)療和保健中的作用。國務(wù)院有關(guān)部門在各自的職責(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 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)督管理部門設(shè)置或者確定的藥品檢驗機(jī)構(gòu)，承擔(dān)依法實施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗工作。 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(zhǔn)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)。 Article 9 Pharmaceutical producing enterprises must anize production in accordance with the Standards for Quality Control of Pharmaceutical Production formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the Standards, and shall issue certificates to those qualified ones. 《藥品生產(chǎn)質(zhì)量管理規(guī)范》的具體實施辦法、實施步驟由國務(wù)院藥品監(jiān)督管理部門規(guī)定。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。 products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory. 第十三條 經(jīng)國務(wù)院藥品監(jiān)督管理部門或者國務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。 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(zhǔn)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。 Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Trading stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the Standards for Quality Control of Pharmaceutical Trading in accordance with relevant regulations, and issue certifications t