药品生产监督管理办法 (中英文)

药品生产监督管理办法Measures for the Supervision over and Administration ofPharmaceutical Production国家食品药品监督管理总局State Food and Drug Administration药品生产监督管理办法Measures for the Supervision over and Administration of Pharmaceutical Production （2004年8月5日国家食品药品监督管理局令第14号公布根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正）The Measures for the Supervision over and Administration of Pharmaceutical Production, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration, are hereby promulgated, and shall come into force as of the date of promulgation.第一章总则Chapter I General Provisions第一条为加强药品生产的监督管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法》、《药品管理法实施条例》），制定本办法。

Article 1 With a view to strengthening the supervision over and administration of pharmaceutical production, the present Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China, Regulation on the Implementation of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the Pharmaceutical Administration Law, Regulation on the Implementation of the Pharmaceutical Administration Law).第二条药品生产监督管理是指食品药品监督管理部门依法对药品生产条件和生产过程进行审查、许可、监督检查等管理活动。

Article 2 The supervision over and administration of pharmaceutical production shall refer to the activities of the food and drug supervision and administration departments who make examination, licensing, supervision and inspection on pharmaceutical production conditions and process and other administrative activities.第三条国家食品药品监督管理总局主管全国药品生产监督管理工作；省、自治区、直辖市食品药品监督管理部门负责本行政区域内的药品生产监督管理工作。

Article 3 The State Food and Drug Administration shall take charge of the work of supervision over and administration of pharmaceutical production nationwide. The food and drug supervision and administration department of the provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision over and administration of pharmaceutical production within their own administrative regions.第二章开办药品生产企业的申请与审批Chapter II Application for and Examination and Approval of the Launching of Pharmaceutical Production Enterprises第四条开办药品生产企业，除应当符合国家制定的药品行业发展规划和产业政策外，还应当符合以下条件：Article 4 When launching a pharmaceutical production enterprise, the following conditions shall also be met in addition to meeting the pharmaceutical industry development plan and industrial policies of the state:（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，企业法定代表人或者企业负责人、质量负责人无《药品管理法》第七十五条规定的情形；1. Having technicians in pharmacology, engineers and technicians and corresponding technical workers whose qualifications have been certified; and the legal representative or responsible person of the enterprise and the person in charge of quality having no circumstances as prescribed in Article 75 of the Pharmaceutical Administration Law;（二）具有与其药品生产相适应的厂房、设施和卫生环境；2. Having workshops, facilities and sanitation environment fitting in with pharmaceutical production;（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；3. Having institutions, personnel that are able to make quality control and inspection on the pharmaceuticals produced, and necessary apparatus and equipment; and（四）具有保证药品质量的规章制度。

国家有关法律、法规对生产麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等另有规定的，依照其规定。

4. Having regulations that can ensure the pharmaceutical quality.In case the relevant state laws and regulations have different provisions on the production of narcotic pharmaceuticals, psychotropic pharmaceuticals, toxic pharmaceuticals for medical treatment use, radioactive pharmaceuticals, precursor chemicals of the pharmaceutical category, etc., those provisions shall be followed.第五条开办药品生产企业的申请人，应当向拟办企业所在地省、自治区、直辖市食品药品监督管理部门提出申请，并提交以下材料：Article 5 An applicant for launching a pharmaceutical production enterprise shall file an application to the food and drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government at his/its locality, and submit the following documents:（一）申请人的基本情况及其相关证明文件。

1. Basic information of the applicant and the relevant certificate documents;（二）拟办企业的基本情况，包括拟办企业名称、生产品种、剂型、设备、工艺及生产能力；拟办企业的场地、周边环境、基础设施等条件说明以及投资规模等情况说明。

2. Basic conditions of the planned enterprise, including the name of the planned enterprise, varieties of production, type of medicament, equipment, technics and throughput; statements on the site of the enterprise, environment around the sites, and infrastructures, etc., as well as the statements on investment scale and other conditions;（三）企业营业执照，生产地址及注册地址、企业类型、法定代表人或者企业负责人。