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| Announcement of the National Medical Products Administration of Issuing the Measures for Administration of Certification of the Good Laboratory Practice for Nonclinical Laboratory Studies | | 国家药监局关于发布《药物非临床研究质量管理规范认证管理办法》的公告 |
| (Announcement No. 15 [2023] of the National Medical Products Administration) | | （国家药品监督管理局公告2023年第15号） |
| For the purpose of further regulating the certification and supervision of the good laboratory practice for nonclinical laboratory studies, the National Medical Products Administration has revised the Measures for Administration of Certification of the Good Laboratory Practice for Nonclinical Laboratory Studies, which are hereby issued and shall come into force on July 1, 2023. | | 为进一步规范药物非临床研究质量管理规范认证和监督管理工作，国家药品监督管理局组织修订了《药物非临床研究质量管理规范认证管理办法》，现予发布。自2023年7月1日起施行。 |
| | 特此公告。 |
| Annex: Measures for Administration of Certification of the Good Laboratory Practice for Nonclinical Laboratory Studies | | 附件：药物非临床研究质量管理规范认证管理办法 |
| National Medical Products Administration | | 国家药监局 |
| January 19, 2023 | | 2023年1月19日 |
| Annex | | 附件 |
| Measures for Administration of Certification of the Good Laboratory Practice for Nonclinical Laboratory Studies | | 药物非临床研究质量管理规范认证管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 These Measures are formulated in accordance with the Medicinal Product Administration Law of the People's Republic of China, the Regulation for the Implementation of the Medicinal Product Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, and other laws, regulations, and rules, for the purposes of strengthening the supervision and administration of nonclinical laboratory studies and regulating the administration of certification of the good laboratory practice (“GLP”) for nonclinical laboratory studies. | | 第一条 为加强药物非临床研究的监督管理，规范药物非临床研究质量管理规范（GLP）认证管理工作，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》和《药品注册管理办法》等法律、法规、规章，制定本办法。 |
| Article 2 “GLP certification” means the process by which the National Medical Products Administration organizes, according to the application, the inspection and evaluation of the GLP for institutions that perform nonclinical laboratory studies. | | 第二条 GLP认证是指国家药品监督管理局依申请组织对药物非临床安全性评价研究机构实施GLP的情况进行检查、评定的过程。 |
| Article 3 The National Medical Products Administration shall be in charge of administering the nationwide GLP certification, establishing the system for the administration of the GLP certification, and organizing the supervision and administration of relevant institutions. The Center for Food and Drug Inspection of the National Medical Products Administration (hereinafter referred to as the “Inspection Center”) shall be in charge of the examination of materials relating to the GLP certification, on-site inspection, comprehensive evaluation, and conducting the supervision and inspection of relevant institutions. The Center for Administrative Services and Complaints & Reports of the National Medical Products Administration (hereinafter referred to as the “Acceptance and Reporting Center”) shall be in charge of the acceptance of applications for the GLP certification and other tasks. | | 第三条 国家药品监督管理局主管全国GLP认证管理工作，负责建立GLP认证管理工作制度并实施行政审批，组织对相关机构进行监督管理。国家药品监督管理局食品药品审核查验中心（以下简称核查中心）负责开展GLP认证相关资料审查、现场检查、综合评定以及实施对相关机构的监督检查等工作。国家药品监督管理局行政事项受理服务和投诉举报中心（以下简称受理和举报中心）承担GLP认证的受理等工作。 |
| Provincial-level medicinal product regulatory departments shall be in charge of the day-to-day supervision and administration of institutions that perform nonclinical laboratory studies within their respective jurisdictions, organizing the supervision and inspection, and investigating and dealing with illegal acts. | | 省级药品监督管理部门负责本行政区域内药物非临床安全性评价研究机构的日常监督管理工作，组织开展监督检查，查处违法行为。 |
| Chapter II Application and Acceptance | | 第二章 申请与受理 |
| Article 4 An institution that intends to conduct nonclinical laboratory studies within the territory of the People's Republic of China in support of the application for drug registration shall apply for the GLP certification. | | 第四条 在中华人民共和国境内拟开展用于药品注册申请的药物非临床安全性评价研究的机构，应当申请GLP认证。 |
| Article 5 An institution applying for the GLP certification (hereinafter referred to as the “application institution”) shall be a legal person. | | 第五条 申请GLP认证的机构（以下简称申请机构）应当是法人。 |
| An application institution may apply for the GLP certification of single or multiple trials according to its research conditions. | | 申请机构可以根据本机构的研究条件，申请单个或者多个试验项目的GLP认证。 |
| The application institution shall perform nonclinical laboratory studies according to the requirements of the GLP and the relevant technical guidelines issued by the National Medical Products Administration. Before applying for the GLP certification, each trial shall complete at least one research task. | | 申请机构应当按照GLP的要求和国家药品监督管理局公布的相关技术指导原则开展药物非临床安全性评价研究。申请GLP认证前，每个试验项目应当完成至少一项研究工作。 |
| Article 6 An application institution shall submit the Application Form for Certification of the Good Laboratory Practice for Nonclinical Laboratory Studies (see Annex) and other application materials to the Acceptance and Reporting Center in accordance with the provisions. The official seal of the application institution shall be affixed to the photocopies of the qualification documents of the application institution in the application materials. The specific requirements for the application materials shall be formulated by the Inspection Center. | | 第六条 申请机构应当按照规定向受理和举报中心报送《药物非临床研究质量管理规范认证申请表》（见附件）和其他申请资料。申请资料中申请机构主体资格证明文件复印件应当加盖申请机构公章。申请资料的具体要求由核查中心制定。 |
| Article 7 The Acceptance and Reporting Center shall make a decision on whether to accept the application within five days of receipt of the application materials, and inform in writing the application institution and the provincial-level medicinal product regulatory department where the application institution is located. | | 第七条 受理和举报中心在收到申请资料之日起5日内作出是否受理的决定，并书面告知申请机构和申请机构所在地省级药品监督管理部门。 |
| The Acceptance and Reporting Center shall, within three days from the date of acceptance, transfer the application materials to the Inspection Center. | | 受理和举报中心应当自受理之日起3日内，将申请资料转交核查中心。 |
| Chapter III Review of Materials and On-site Inspection | | 第三章 资料审查与现场检查 |
| Article 8 After receiving the application materials, the Inspection Center shall complete the review of the materials within ten days. If supplementary materials are required, the Inspection Center shall give the application institution one-time and written notification of the materials required to be added. The application institution shall submit all supplementary materials as required within 20 days. | | 第八条 核查中心收到申请资料后，应当在10日内完成资料审查。需要补充资料的，核查中心应当一次性书面通知申请机构要求补充的内容。申请机构应当在20日内按照要求提交全部补充资料。 |
| If the Inspection Center deems that there are substantive defects in the application materials that cannot be corrected, it shall no longer require the application institution to supplement the materials and instead make a review conclusion of granting no approval based on the existing application materials and explain the reasons, and report to the National Medical Products Administration for approval. | | 核查中心认为申请资料存在实质性缺陷无法补正的，不再要求申请机构补充资料，基于已有申请资料作出不予批准的审核结论并说明理由，报国家药品监督管理局审批。 |
| Article 9 If the materials meet the review requirements, the Inspection Center shall formulate an inspection plan within 20 days and organize the implementation of on-site inspection. | | 第九条 资料审查符合要求的，核查中心在20日内制订检查方案，并组织实施现场检查。 |
| The Inspection Center shall, five days in advance, notify the application institution and the provincial-level medicinal product regulatory department where the application institution is located of the on-site inspection. | | 核查中心应当提前5日将现场检查安排通知申请机构和申请机构所在地省级药品监督管理部门。 |
| An on-site inspection lasts 3 to 5 days as a general rule, it may be adjusted appropriately as needed in the inspection work. | | 现场检查时间一般为3至5日，根据检查工作的需要可适当调整。 |
| Article 10 The team leader shall take full responsibility for an on-site inspection, and an inspection team shall be composed of at least two persons with GLP inspector qualifications. Inspectors shall be familiar with and understand relevant professional knowledge, and when necessary, may engage relevant experts to participate in the on-site inspection. | | 第十条 现场检查实行组长负责制，检查组应当由2名以上具备GLP检查员资格的人员组成。检查员应当熟悉和了解相关专业知识，必要时可以聘请有关专家参加现场检查。 |
| Inspectors and inspection experts shall sign a declaration of no conflict of interest and a confidentiality agreement. If there is an interest relationship with the institution under inspection or there are other circumstances that may affect the fairness of the on-site inspection results, they shall take the initiative to declare such information and disqualify themselves. The trade secrets, undisclosed information, or confidential business information of the institution under inspection shall be kept confidential. | | 检查员和检查专家应当签署无利益冲突声明和保密协议。与被检查机构存在利益关系或者有其他可能影响现场检查结果公正性的情况时，应当主动申明并回避。对被检查机构的商业秘密、未披露信息或者保密商务信息应当保密。 |
| Article 11 The provincial-level medicinal product regulatory department where the application institution is located shall send observers to participate in an on-site inspection, and be in charge of coordinating and liaising the work related to the on-site inspection. | | 第十一条 申请机构所在地省级药品监督管理部门应当派观察员参加现场检查，并负责协调和联络与GLP现场检查有关的工作。 |
| Article 12 An application institution shall actively cooperate with the inspection team. As required by the inspection team, it shall specify the person in charge of the inspection site, open relevant venues or areas, cooperate on the inspection of relevant facilities and equipment, provide relevant materials required for the inspection, and truthfully answer the inspection team's questions. | | 第十二条 申请机构应当积极配合检查组工作，按照检查组要求，明确检查现场负责人，开放相关场所或者区域，配合对相关设施设备的检查，提供检查所需的相关资料，如实回答检查组的询问。 |
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