Measures for the Supervision over and Administration of Pharmaceutical Production | | 药品生产监督管理办法 |
| (Promulgated by the Order No. 14 of the China Food and Drug Administration on August 5, 2004; and amended in accordance with the Decision to Amend Certain Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017) | | （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） |
| Chapter I General Provisions | | 第一章 总 则 |
| 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 2 The supervision over and administration of pharmaceutical production shall refer to the activities of food and drug administrative departments who make examination, licensing, supervision and inspection on pharmaceutical production conditions and process and other administrative activities. | | 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 3 The China Food and Drug Administration shall take charge of the work of supervision over and administration of pharmaceutical production nationwide. The food and drug administrative departments 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。 |
| Chapter II Application for and Examination and Approval of the Launching of Pharmaceutical Production Enterprises | | 第二章 开办药品生产企业的申请与审批 |
| 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: | | 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： |
| 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; | | （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； |
| 2. Having workshops, facilities and sanitation environment fitting in with pharmaceutical production; | | （二）具有与其药品生产相适应的厂房、设施和卫生环境； |
| 3. Having institutions, personnel that are able to make quality control and inspection on the pharmaceuticals produced, and necessary apparatus and equipment; and | | （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. Having regulations that can ensure the pharmaceutical quality. | | （四）具有保证药品质量的规章制度。 |
| 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. | | 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。 |
| Article 5 An applicant for launching a pharmaceutical production enterprise shall file an application to the food and drug administrative department of the province, autonomous region, or municipality directly under the Central Government at his/its locality, and submit the following documents: | | 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： |
| 1. Basic information of the applicant and the relevant certificate documents; | | （一）申请人的基本情况及其相关证明文件。 |
| 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; | | （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。 |
| 3. Business license of the enterprise, production address and registered address, type of the enterprise, legal representative or the person in charge of the enterprise; | | （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。 |
| 4. Plan of the organizations of the planned enterprise (indicating the functions of each sector and their correlations, responsible person of each sector); | | （四）拟办企业的组织机构图（注明各部门的职责及相互关系、部门负责人）。 |
| 5. Resumes, educational backgrounds and title certificates of the legal representative, responsible person of the planned enterprise and the responsible person of each sector of the enterprise; registration form for the technicians of pharmacology and relevant professionals, engineers and technicians, technical workers whose qualifications have been certified according to law with the indication of the sectors and posts they are in; the proportion statement of the senior, medium and preliminary technicians; | | （五）拟办企业的法定代表人、企业负责人、部门负责人简历，学历和职称证书；依法经过资格认定的药学及相关专业技术人员、工程技术人员、技术工人登记表，并标明所在部门及岗位；高级、中级、初级技术人员的比例情况表。 |
| 6. The map for the environment around the planned enterprise, general plane figure, storage plane figure, plane figure of quality inspection place; | | （六）拟办企业的周边环境图、总平面布置图、仓储平面布置图、质量检验场所平面布置图。 |
| 7. Plan for the arrangement of production technics of the enterprise (including dressing room, water closet, passage for stream of people and material circulation, and air brake, etc., and indicating the flowing direction of the people and materials and the grade of air cleanliness factor), plan of the blow, return and ventilation of air cleansing system, and the plan for arrangement of technics and equipment; | | （七）拟办企业生产工艺布局平面图（包括更衣室、盥洗间、人流和物流通道、气闸等，并标明人、物流向和空气洁净度等级），空气净化系统的送风、回风、排风平面布置图，工艺设备平面布置图。 |
| 8. The scope, type of medicament, varieties, quality standard and basis of the pharmaceuticals to be produced; | | （八）拟生产的范围、剂型、品种、质量标准及依据。 |
| 9. The technic flow chart of the type of medicament and varieties of pharmaceuticals to be produced, with the major quality reference points and items indicated; | | （九）拟生产剂型及品种的工艺流程图，并注明主要质量控制点与项目。 |
| 10. General situation on the validation of air cleansing system, water treatment system and the major equipment; conditions of checkout of the production and inspection apparatus, instruments, and weighing apparatus; | | （十）空气净化系统、制水系统、主要设备验证概况；生产、检验仪器、仪表、衡器校验情况。 |
| 11. Lists of major production equipment and inspection apparatus; and | | （十一）主要生产设备及检验仪器目录。 |
| 12. Contents of documents on the production management and quality control of the planned enterprise. | | （十二）拟办企业生产管理、质量管理文件目录。 |
| The applicant shall be responsible for the truthfulness of all the contents of the application documents. | | 申请人应当对其申请材料全部内容的真实性负责。 |
| Article 6 In case a pharmaceutical production enterprise divides part of the production workshops and forms an independent pharmaceutical production enterprise, it shall handle the Pharmaceutical Production License in accordance with the provisions of Articles 4 and 5 of the present Measures. | | 第六条 药品生产企业将部分生产车间分立，形成独立药品生产企业的，按照本办法第四条、第五条的规定办理《药品生产许可证》。 |
| Article 7 The food and drug administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government shall, after receiving the application, make handling according to the following circumstances respectively: | | 第七条 省、自治区、直辖市食品药品监督管理部门收到申请后，应当根据下列情况分别作出处理： |
| 1. In case the matters applied for do not fall within the scope of functions and powers of the corresponding department according to law, the department shall make decision on not accepting it, and notify the applicant to apply to the relevant administrative department; | | （一）申请事项依法不属于本部门职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请； |
| 2. In case the application documents have mistakes that can be corrected on the spot, the applicant shall be allowed to correct on the spot; | | （二）申请材料存在可以当场更正的错误的，应当允许申请人当场更正； |
| 3. In case the application documents are incomplete or do not correspond with the requirements for the examination on the format, the department shall issue the Notice on Supplementing and Correcting the Documents to the applicant on the spot or within 5 workdays, and notify the applicant of all the contents to be supplemented and corrected. If it fails to notify within the time limit, the date of acceptance shall be the date when the department has received the application documents; and | | （三）申请材料不齐全或者不符合形式审查要求的，应当当场或者在5个工作日内发给申请人《补正材料通知书》，一次性告知申请人需要补正的全部内容，逾期不告知的，自收到申请材料之日起即为受理； |
| 4. If the application documents are complete and correspond with the examination requirements, or the applicant has submitted all the supplementary documents as required, the application shall be accepted. | | （四）申请材料齐全、符合形式审查要求，或者申请人按照要求提交全部补正材料的，予以受理。 |
| In case any food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government accepts or does not accept the application for the establishment of the pharmaceutical production enterprise, it shall issue a Notice of Acceptance or Notice of Not Acceptance, which is sealed by the special seal of the corresponding department and indicated with the date thereof. | | 省、自治区、直辖市食品药品监督管理部门受理或者不予受理药品生产企业开办申请的，应当出具加盖本部门受理专用印章并注明日期的《受理通知书》或者《不予受理通知书》。 |
| Article 8 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make decision within 30 workdays after the application is accepted. | | 第八条 省、自治区、直辖市食品药品监督管理部门应当自收到申请之日起30个工作日内，作出决定。 |
| If the application meets the requirements after examination, the department shall grant approval, and verify and issue the Pharmaceutical Production License within 10 workdays from the date when the decision on written approval has been made. If the application does not meet the requirements, the department shall make a written decision on not approval, and explain the reasons, meanwhile notify the applicant of his right to apply for administrative reconsideration or file an administrative litigation according to law. | | 经审查符合规定的，予以批准，并自书面批准决定作出之日起10个工作日内核发《药品生产许可证》；不符合规定的，作出不予批准的书面决定，并说明理由，同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利。 |
| Article 9 In case of establishing a new pharmaceutical production enterprise, or a pharmaceutical production enterprise builds a new pharmaceutical production workshop or newly adds production form of prepared pharmaceuticals, the enterprise shall apply for certification of the Pharmaceutical Production Quality Control Criterions to the corresponding food and drug administrative department in accordance with the provisions of the China Food and Drug Administration within 30 days from the date of obtaining pharmaceutical production certificate documents or from the date when it is approved to make production officially. | | 第九条 新开办药品生产企业、药品生产企业新建药品生产车间或者新增生产剂型的，应当自取得药品生产证明文件或者经批准正式生产之日起30日内，按照国家食品药品监督管理总局的规定向相应的食品药品监督管理部门申请《药品生产质量管理规范》认证。 |
| Article 10 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice on the website or at the office place of the administrative department on the conditions, procedures and time limit for applying for the Pharmaceutical Production License, the whole documents to be submitted and the model text of the application letter, etc.. | | 第十条 省、自治区、直辖市食品药品监督管理部门应当在行政机关的网站和办公场所公示申请《药品生产许可证》所需要的条件、程序、期限、需要提交的全部材料的目录和申请书示范文本等。 |
| The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall open the relevant information on the issuance of Pharmaceutical Production License. The general public shall have the right to consult. | | 省、自治区、直辖市食品药品监督管理部门颁发《药品生产许可证》的有关信息，应当予以公开，公众有权查阅。 |
| Article 11 The food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice on the process and result of examination and approval when making examination on the application of the pharmaceutical production enterprise. The applicant and the interested parties may submit written opinions to make statements and defense on the matters directly relating to their major interests. | | 第十一条 省、自治区、直辖市食品药品监督管理部门对药品生产企业开办申请进行审查时，应当公示审批过程和审批结果。申请人和利害关系人可以对直接关系其重大利益的事项提交书面意见进行陈述和申辩。 |
| Article 12 In case the application for the establishment of any pharmaceutical production enterprise directly involves major interest relations between the applicant and others, the food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall notify the applicant and the interested parties that they may enjoy the right to apply for hearing according to laws and regulations and other provisions of China Food and Drug Administration. When making examination on the application for establishment of pharmaceutical production enterprises, the food and drug administrative department of the provinces, autonomous regions, and municipalities directly under the Central Government shall make a public notice to the society on the major licensing matters concerning the public interests, and hold hearings. | | 第十二条 药品生产企业开办申请直接涉及申请人与他人之间重大利益关系的，省、自治区、直辖市食品药品监督管理部门应当告知申请人、利害关系人可以依照法律、法规以及国家食品药品监督管理总局的其他规定享有申请听证的权利；在对药品生产企业开办申请进行审查时，省、自治区、直辖市食品药品监督管理部门认为涉及公共利益的重大许可事项，应当向社会公告，并举行听证。 |
| Chapter III Administration on Pharmaceutical Production License | | 第三章 药品生产许可证管理 |
| Article 13 The Pharmaceutical Production License shall have the original copy and the duplicate, the duplicate shall have the same legal effect as the original one, and the period of validity shall be five years. | | 第十三条 《药品生产许可证》分正本和副本，正本、副本具有同等法律效力，有效期为5年。 |
| The Pharmaceutical Production License shall be printed uniformly by the China Food and Drug Administration. | | 《药品生产许可证》由国家食品药品监督管理总局统一印制。 |
| Article 14 The Pharmaceutical Production License shall bear the serial number of the License, name of the enterprise, legal representative, enterprise type, registration address, production address, production scope, license issuing organ, date for license issuance, period of validity, and other items, etc.. Among them the licensing matters that are subject to the approval of the food and drug administrative department shall be: responsible person of the enterprise, scope of production, and production address. | | 第十四条 《药品生产许可证》应当载明许可证编号、企业名称、法定代表人、企业负责人、企业类型、注册地址、生产地址、生产范围、发证机关、发证日期、有效期限等项目。其中由食品药品监督管理部门核准的许可事项为：企业负责人、生产范围、生产地址。 |
| Such items as the name of the enterprise, legal representative, registration address, and enterprise type shall be consistent with the relevant contents as specified in the business license issued by the administrative department for industry and commerce. | | 企业名称、法定代表人、注册地址、企业类型等项目应当与工商行政管理部门核发的营业执照中载明的相关内容一致。 |
| The name of an enterprise shall comply with the principle of classified administration of pharmaceutical production enterprises. The production address shall be filled in according to the actual pharmaceutical production address. The serial number of the License and the production scope shall be filled in according to the methods and classes as prescribed by the China Food and Drug Administration. | | 企业名称应当符合药品生产企业分类管理的原则；生产地址按照药品实际生产地址填写；许可证编号和生产范围按照国家食品药品监督管理总局规定的方法和类别填写。 |
| Article 15 The alteration of Pharmaceutical Production License shall include the alteration of the licensing matters and alteration of registration matters. | | 第十五条 《药品生产许可证》变更分为许可事项变更和登记事项变更。 |
| The alteration of licensing matters shall refer to the alteration of the responsible person of the enterprise, production scope and production address. | | 许可事项变更是指企业负责人、生产范围、生产地址的变更。 |
| The alteration of the registration matters shall refer to the alteration of the matters as listed in paragraph 2 of Article 14 of the present Measures. | | 登记事项变更是指本办法第十四条第二款所列事项的变更。 |
| Article 16 In case a pharmaceutical production enterprise alters the licensing matters in the Pharmaceutical Production License, it shall file an alteration application to the original license issuing organ 30 days before the occurrence of alteration of the original licensing matters. No enterprise may alter the licensing matters at will without authorization. | | 第十六条 药品生产企业变更《药品生产许可证》许可事项的，应当在原许可事项发生变更30日前，向原发证机关提出《药品生产许可证》变更申请。未经批准，不得擅自变更许可事项。 |
| The original license issuing organ shall make a decision on whether to approve the alteration or not within 15 workdays from the date when the application for alteration of an enterprise is received. If it does not grant the alteration, it shall explain the reason in writing, and notify the applicant of his/its rights to apply for administrative reconsideration or to lodge administrative litigation according to law. | | 原发证机关应当自收到企业变更申请之日起15个工作日内作出是否准予变更的决定。不予变更的，应当书面说明理由，并告知申请人享有依法申请行政复议或者提起行政诉讼的权利。 |
| In case of alteration of production scope or production address, a pharmaceutical production enterprise shall submit the relevant documents concerning the contents of alteration as prescribed in Article 5 of the present Measures, and report to the food and drug administrative department of the province, autonomous region, and municipality directly under the Central Government at its locality for examination and determination. | | 变更生产范围或者生产地址的，药品生产企业应当按照本办法第五条的规定提交涉及变更内容的有关材料，并报经所在地省、自治区、直辖市食品药品监督管理部门审查决定。 |
| After a pharmaceutical production enterprise has gone through formalities for alteration of licensing matters in the Pharmaceutical Production License, it shall handle formalities for the alteration of the enterprise registration to the administrative department for industry and commerce in time. | | 药品生产企业依法办理《药品生产许可证》许可事项的变更手续后，应当及时向工商行政管理部门办理企业注册登记的变更手续。 |
| Article 17 In case a pharmaceutical production enterprise alters the registration matters in the Pharmaceutical Production License, it shall apply for alteration registration on Pharmaceutical Production License to the original license issuing organ within 30 days after the alteration is approved by the administrative department for industry and commerce. | | 第十七条 药品生产企业变更《药品生产许可证》登记事项的，应当在工商行政管理部门核准变更后30日内，向原发证机关申请《药品生产许可证》变更登记。原发证机关应当自收到企业变更申请之日起15个工作日内办理变更手续。 |
| Article 18 After the alteration of the Pharmaceutical Production License, the original license issuing organ shall record the contents and time of alteration on the duplicate of the Pharmaceutical Production License, and reissue the original copy of the Pharmaceutical Production License in light of the contents altered, and take back the former original copy of the Pharmaceutical Production License. The period of validity of the Pharmaceutical Production License shall remain unchanged. | | 第十八条 《药品生产许可证》变更后，原发证机关应当在《药品生产许可证》副本上记录变更的内容和时间，并按照变更后的内容重新核发《药品生产许可证》正本，收回原《药品生产许可证》正本，变更后的《药品生产许可证》有效期不变。 |
Article 19 In case the period of validity of the Pharmaceutical Production License expires and there is necessity to continue to produce pharmaceuticals, the pharmaceutical production enterprise shall apply for changing of the Pharmaceutical Production License to the original license issuing organ 6 months before the expiry of the period of validity.
．．．．．． | | 第十九条 《药品生产许可证》有效期届满，需要继续生产药品的，药品生产企业应当在有效期届满前6个月，向原发证机关申请换发《药品生产许可证》。
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