1、 Pharmaceutical Administration Law of the Peoples Republic of China (2015 Amendment)Effective 中华人 民共和国药 品管理法(2015 修正) 现 行有效 Issuing authority: Standing Committee of the National Peoples Congress Document Number: Order No. 27 of the President of the Peoples Republic of China Date issued: 04-24-2015 L
2、evel of Authority: Laws Area of law: Health and Sanitation Pharmaceutical Administration Law of the Peoples Republic of China 中华人民共和国药品管理法 (Adopted at the Seventh Session of the Standing Committee of the Sixth National Peoples Congress on September 20, 1984, revised at the Twentieth Session of the N
3、inth National Peoples Congress on February 28, 2001 and amended for the first time in accordance with the Decision on Amending Seven Laws Including the Marine Environment Protection Law of the Peoples Republic of China at the Sixth Session of the Standing Committee of the Twentieth National Peoples
4、Congress on December 28, 2013; and amended for the second time in accordance with the Decision on Amending the Pharmaceutical Administration Law of the Peoples Republic of China at the 14th Session of the Standing Committee of the Twelfth National Peoples Congress of the Peoples Republic of China on
5、 April 24, 2015) （1984 年 9 月 20 日第六届全 国人民代 表大会常务委员会第七次会议通过 2001 年 2 月 28 日第九届全国人民代 表大会常 务委员会第二十次会议修订根据 2013 年 12 月 28 日第十二届全国人民 代表大会 常务委员会第六次会议关于修改中 华人民共和国海洋环境保护法等七部 法律的决定第一次修正根据 2015 年 4 月 24 日第十二届全国人民代表 大会常务 委员会第十四次会议关于修改中华 人民共和国药品管理法的决定第二 次修正） Contents 目录 Chapter I General Provisions 第一章 总则 Chapt
6、er II Administration of Pharmaceutical Producing Enterprises 第二章 药品生产企业管理 Chapter III Administration of Pharmaceutical Trading Enterprises 第三章 药品经营企业管理 Chapter IV Administration of Pharmaceuticals at Medical Organizations 第四章 医疗机构的药剂管理 Chapter V Pharmaceutical Administration 第五章 药品管理 Chapter VI Admi
7、nistration of the Packaging of Pharmaceuticals 第六章 药品包装的管理 Chapter VII Administration of the Prices and Advertising of Pharmaceuticals 第七章 药品价格和广告的管理 Chapter VIII Supervision over Pharmaceuticals 第八章 药品监督 Chapter IX Legal Responsibility 第九章 法律责任 Chapter X Supplementary Provisions 第十章 附则 Chapter I Ge
8、neral Provisions 第一章 总则 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. 第一条 为加强药品监督管理，保 证药品质量，保障人体用药安全，维护 人民身体健康和用药的合法权益，特制 定本法。 Ar
9、ticle 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 Peoples Republic of China. 第二条 在中华人民共和国境内从 事药品的研制、生产、经营、使用和监 督管理的单位或者个人，必须遵守本 法。 Article 3 The State shall develop bo
10、th modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care. 第三条 国家发展现代药和传统 药，充分发挥其在预防、医疗和保健中 的作用。 The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal cro
11、ps. 国家保护野生药材资源，鼓励培育中药 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 organizations in the research and development of new medicine. 第四条 国家鼓励研究和创制新 药，保护公民、法人和其他组织研究、 开发新药的合法权益。 Ar
12、ticle 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 ph
13、armaceuticals related to the scope of their functions. 第五条 国务院药品监督管理部门 主管全国药品监督管理工作。国务院有 关部门在各自的职责范围内负责与药品 有关的监督管理工作。 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for t
14、he 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
15、their functions. 省、自治区、直辖市人民政府药品监督 管理部门负责本行政区域内的药品监督 管理工作。省、自治区、直辖市人民政 府有关部门在各自的职责范围内负责与 药品有关的监督管理工作。 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 国
16、务院药品监督管理部门应当配合国务 院经济综合主管部门，执行国家制定的 药品行业发展规划和产业政策。 pharmaceutical development plans and industrial policies formulated by the State. Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the
17、work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations. 第六条 药品监督管理部门设置或 者确定的药品检验机构，承担依法实施 药品审批和药品质量监督检查所需的药 品检验工作。 Chapter II Administration of Pharmaceutical Producing Enterprises 第二章 药品生产企业管理 Article 7 The establishment of a pharmace
18、utical 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. without which n
19、o pharmaceuticals shall be produced. 第七条 开办药品生产企业，须经 企业所在地省、自治区、直辖市人民政 府药品监督管理部门批准并发给药品 生产许可证。无药品生产许可证 的，不得生产药品。 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. 药品生
20、产许可证应当标明有效期和 生产范围，到期重新审查发证。 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 formula
21、ted by the State to avoid the instance of a repeat establishment. 药品监督管理部门批准开办药品生产企 业，除依据本法第八条规定的条件外， 还应当符合国家制定的药品行业发展规 划和产业政策，防止重复建设。 Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met: 第八条 开办药品生产企业，必须 具备以下条件： (1) It shall be staffed with legally ce
22、rtified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers. （一）具有依法经过资格认定的药学技 术人员、工程技术人员及相应的技术工 人； (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced. （二）具有与其药品生产相适应的厂 房、设施和卫生环境； (3)
23、 It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment. （三）具有能对所生产药品进行质量管 理和质量检验的机构、人员以及必要的 仪器设备； (4) It shall have rules and regulations to ensure the quality of medicines. （四）具有保证药品质量的规章制度。 Article 9
24、Pharmaceutical producing enterprises must organize production in accordance with the Standards for Quality Control of Pharmaceutical Production formulated by the pharmaceutical supervisory and 第九条 药品生产企业必须按照国 务院药品监督管理部门依据本法制定的 药品生产质量管理规范组织生产。administrative departments under the State Council on the
25、basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the Standards for Quality Control of Pharmaceutical Production and shall issue certificates to those qualified ones. 药品监督管理部门按照规定对药
26、品生产 企业是否符合药品生产质量管理规 范的要求进行认证；对认证合格的， 发给认证证书。 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. 药品生产质量管理规范的具体实施
27、办法、实施步骤由国务院药品监督管理 部门规定。 Article 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments
28、of pharmaceuticals under the State Council, and the record of production must be complete 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 auth
29、orities. 第十条 除中药饮片的炮制外，药 品必须按照国家药品标准和国务院药品 监督管理部门批准的生产工艺进行生 产，生产记录必须完整准确。药品生产 企业改变影响药品质量的生产工艺的， 必须报原批准部门审核批准。 The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must
30、conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of
31、pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council. 中药饮片必须按照国家药品标准炮制； 国家药品标准没有规定的，必须按照 省、自治区、直辖市人民政府药品监督 管理部门制定的炮制规范炮制。省、自 治区、
32、直辖市人民政府药品监督管理部 门制定的炮制规范应当报国务院药品监 督管理部门备案。 Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use. 第十一条 生产药品所需的原料、 辅料，必须符合药用要求。 Article 12 The pharmaceutical producing enterprises must conduct quality inspections on
33、 the pharmaceuticals they produce; 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
34、 under the central government shall not leave the factory. 第十二条 药品生产企业必须对其 生产的药品进行质量检验；不符合国家 药品标准或者不按照省、自治区、直辖 市人民政府药品监督管理部门制定的中 药饮片炮制规范炮制的，不得出厂。 Article 13 With the approval of the drug regulatory department of the peoples government of a province, autonomous region, or municipality directly under
35、the Central Government, a pharmaceutical producing enterprise may produce pharmaceuticals as authorized by others. 第十三条 经省、自治区、直辖市 人民政府药品监督管理部门批准，药品 生产企业可以接受委托生产药品。 Chapter III Administration of Pharmaceutical Trading Enterprises 第三章 药品经营企业管理 Article 14 The establishment of pharmaceutical wholesale
36、enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License. The establishment of pharmaceutical retail e
37、nterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals. 第十四条 开办药品批发
38、企业，须 经企业所在地省、自治区、直辖市人民 政府药品监督管理部门批准并发给药 品经营许可证；开办药品零售企业， 须经企业所在地县级以上地方药品监督 管理部门批准并发给药品经营许可 证。无药品经营许可证的，不得 经营药品。 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. 药品经营许可证应当标明有效期和 经营
39、范围，到期重新审查发证。 The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of t
40、his Law. 药品监督管理部门批准开办药品经营企 业，除依据本法第十五条规定的条件 外，还应当遵循合理布局和方便群众购 药的原则。 Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met 第十五条 开办药品经营企业必须 具备以下条件： 1. It shall be staffed with legally certified pharmaceutical technical personnel. （一）具有依法经过资格认定的药学技 术人员； 2.
41、It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades. （二）具有与所经营药品相适应的营业 场所、设备、仓储设施、卫生环境； 3. It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades. （三）具有与所经营药品相适应的
42、质量 管理机构或者人员； 4. It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades. （四）具有保证所经营药品质量的规章 制度。 Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the Standards for Quality Control of Pharmaceutical Trading stip
43、ulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this 第十六条 药品经营企业必须按照 国务院药品监督管理部门依据本法制定 的药品经营质量管理规范经营药 品。药品监督管理部门按照规定对药品Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterpris
44、es meet the requirements of the Standards for Quality Control of Pharmaceutical Trading in accordance with relevant regulations, and issue certifications to qualified enterprises. 经营企业是否符合药品经营质量管理 规范的要求进行认证；对认证合格 的，发给认证证书。 Detailed implementation measures and procedures for the Standards for Quality
45、 Control of Pharmaceutical Trading shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council. 药品经营质量管理规范的具体实施 办法、实施步骤由国务院药品监督管理 部门规定。 Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchas
46、e of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased. 第十七条 药品经营企业购进药 品，必须建立并执行进货检查验收制 度，验明药品合格证明和其他标识；不 符合规定要求的，不得购进。 Article 18 Pharmaceutical trading enterprises
47、 shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical products generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing a
48、nd selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council. 第十八条 药品经营企业购销药 品，必须有真实完整的购销记录。购销 记录必须注明药品的通用名称、剂型、 规格、批号、有效期、生产厂商、购 （销）货单位、购（销）货数量、购销 价格、购（销）货日期及国务院药品监 督管理部门规定的其他内容。 Article 19 It is impe
49、rative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors
