| Announcement of the National Medical Products Administration on Issuing the Provisions on the Administration of Overseas Inspection of Drugs and Medical Devices | | 国家药监局关于发布药品医疗器械境外检查管理规定的公告 |
| (No. 101 [2018]) | | （2018年第101号） |
| In order to regulate the overseas inspection of drugs and medical devices and ensure the quality of imported drugs and medical devices, the National Medical Products Administration has developed the Provisions on the Administration of Overseas Inspection of Drugs and Medical Devices, which is hereby issued and shall come into force on the date of issuance. | | 为规范药品医疗器械境外检查工作，保证进口药品医疗器械质量，国家药品监督管理局制定了《药品医疗器械境外检查管理规定》，现予发布，自发布之日起施行。 |
| | 特此公告。 |
| National Medical Products Administration | | 国家药监局 |
| December 26, 2018 | | 2018年12月26日 |
| Provisions on the Administration of Overseas Inspection of Drugs and Medical Devices | | 药品医疗器械境外检查管理规定 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 These Provisions are developed in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulation on the Supervision and Administration of Medical Devices and other relevant laws and regulations to regulate the overseas inspection of drugs and medical devices. | | 第一条 为规范药品医疗器械境外检查工作，根据《中华人民共和国药品管理法》《医疗器械监督管理条例》等有关法律法规要求，制定本规定。 |
| Article 2 These Provisions shall apply to the inspection of the overseas development, manufacturing and other related processes of drugs and medical devices that have been or are to be sold within the territory of the People's Republic of China. | | 第二条 本规定适用于已在中华人民共和国境内上市或者拟在境内上市药品、医疗器械的境外研制及生产相关过程的检查。 |
| Article 3 The overseas inspection of drugs and medical devices means the inspection conducted by the National Medical Products Administration (hereinafter referred to as the “NMPA”) to confirm the authenticity, reliability and compliance of the processes related to the overseas development and production of drugs and medical devices. | | 第三条 药品、医疗器械境外检查是指国家药品监督管理局（以下简称国家局）为确认药品、医疗器械境外研制、生产相关过程的真实性、可靠性和合规性实施的检查。 |
| Article 4 The NMPA shall be responsible for the overseas inspection and administration of drugs and medical devices, and the Center for Food and Drug Inspection of NM (hereinafter referred to as the “Inspection Center”) responsible for organizing and implementing the overseas inspection of drugs and medical devices. The departments related to the inspection, review and evaluation of drugs and medical devices shall be cooperative in overseas inspections. | | 第四条 国家局负责药品、医疗器械境外检查管理工作，国家药品监督管理局食品药品审核查验中心（以下称核查中心）负责具体组织实施药品、医疗器械境外检查工作。药品、医疗器械的检验、审评、评价等相关部门协助开展境外检查工作。 |
| Article 5 The NMPA shall, in accordance with the requirements for government information disclosure, publicize the basic information about the inspections and the handling results. | | 第五条 国家局按照政府信息公开的要求公开检查的基本情况和处理结果。 |
| Article 6 The inspector and the entity under inspection shall strictly abide by the relevant requirements for cleanness and incorruptness. | | 第六条 检查员和被检查单位应当严格遵守廉政相关要求。 |
| Article 7 The inspector shall strictly abide by laws and regulations and inspection disciplines, and guard state secrets and the secrets of the entity under inspection. | | 第七条 检查员应当严格遵守法律法规、检查纪律，保守国家秘密和被检查单位的秘密。 |
| Chapter II Inspection Tasks | | 第二章 检查任务 |
| Article 8 The NMPA shall, according to the suggestions proposed by relevant departments on the varieties to be inspected and related development and manufacturing sites, determine the inspection tasks through risk assessment and random inspection. If it is really necessary to change the inspection tasks according to the needs of supervision, the inspection tasks may be adjusted in accordance with the relevant provisions of the NMPA on foreign affairs administration of overseas inspection. | | 第八条 国家局根据各相关部门提出的拟检查品种及相关研制、生产场地的建议，通过风险评估和随机抽查方式，确定检查任务。根据监管需要确需对检查任务进行变更的，可按照国家局境外检查外事管理有关规定对检查任务进行调整。 |
| When necessary, the extended inspection may be conducted of the manufacturing sites of raw materials, auxiliary materials and packaging materials, suppliers or other contractual institutions. | | 必要时，可对原料、辅料、包装材料等生产场地、供应商或者其他合同机构等开展延伸检查。 |
| Article 9 For the determination of inspection tasks, the risk factors in the registration, review and approval, supervision and inspection, examination, complaint reporting, adverse reactions and adverse event monitoring of drugs and medical devices shall be taken into consideration with a focus on the following circumstances: | | 第九条 检查任务的确定，应当考虑药品、医疗器械的注册审评审批、监督检查、检验、投诉举报、不良反应和不良事件监测等风险因素。重点考虑以下情形： |
| (1) Potential risks are discovered during review and approval; | | （一）审评审批中发现潜在风险的； |
| (2) The inspection or lot release is not in conformity with the provisions, indicating the existence of risks in the quality management system; | | （二）检验或者批签发不符合规定，提示质量管理体系存在风险的； |
| (3) Adverse drug reaction or adverse events monitoring indicates there may be quality safety risks; | | （三）不良反应或者不良事件监测提示可能存在产品安全风险的； |
| (4) Complaint, reporting or other clues indicate the existence of violations of laws and regulations; | | （四）投诉举报或者其他线索提示存在违法违规行为的； |
| (5) The holder of drug marketing licenses or an applicant for the registration or recordation of medical devices (hereinafter referred to as the “holder”) has adverse records; | | （五）药品上市许可持有人、医疗器械注册人或者备案人（以下简称持有人）有不良记录的； |
| (6) The on-site inspection results of overseas regulatory authorities indicate that there are major problems in the drug marketing license holders system; | | （六）境外监管机构现场检查结果提示持有人质量管理体系存在较大问题的； |
| (7) A second inspection is carried out after the rectification; and | | （七）整改后需要再次开展检查的； |
| (8) Other circumstances where overseas inspection is conducted. | | （八）其他需要开展境外检查的情形。 |
| Article 10 According to the NMPA's overseas inspection tasks, the Inspection Center shall send a Notice of Overseas Inspection (Annex 1) to the holder or his/her agent. The holder shall submit to the Inspection Center a power of attorney (Relevant requirements are shown in Annex 2) and a Basic Information Form for Products Subject to Overseas Inspection (Annex 3) within 20 working days of receipt of the Notice of Overseas Inspection, and submit the site master file and other materials needed for inspection according to the site master file list (Annex 4) within 40 working days. | | 第十条 根据国家局境外检查任务，核查中心应当将《境外检查告知书》（附件1）发送持有人或者其代理人。持有人应当在《境外检查告知书》送达之日起20个工作日内，向核查中心提交授权书（有关要求见附件2）和《境外检查产品基本情况表》（附件3），40个工作日内按照场地主文件清单（附件4）提交场地主文件和其他检查所需材料。 |
| The Inspection Center may, when required for inspection, obtain the technical data related to inspection varieties, which shall be subject to necessary confidentiality measures. After the inspection, the obtained technical data shall be filed into the “inspection” file. | | 核查中心根据检查需要可以调取与检查品种相关的技术资料，调取的技术资料应当采取必要的保密措施，检查结束后归入检查档案。 |
| The holder shall designate an agent in China (For medical devices, an agent of the applicant for the registration or recordation of medical devices shall be designated), and issue a letter of attorney as required. The agent shall be responsible for the liaison between drug regulatory authorities and the holder, the monitoring of adverse drug reactions or medical device adverse events, and product tracing and recall. The agent shall fulfill the responsibilities and obligations of domestically marketing drugs and medical devices as prescribed by laws and regulations, and assist drug regulatory authorities in the inspection of overseas product development and production sites and the investigation into and punishment of violations of laws and regulations. | | 持有人须指定一家中国境内代理人（其中医疗器械应当为医疗器械注册人或者备案人的代理人），并按照有关要求出具授权书。代理人负责药品监管部门与持有人之间的联络、承担药品不良反应或者医疗器械不良事件监测、负责产品追溯召回等工作。代理人应当履行法律法规规定的境内上市药品医疗器械有关责任和义务，协助药品监管部门开展对产品境外研制、生产场地的检查和违法违规行为的查处。 |
| If the holder changes the agent, it shall, after completing the change procedures prescribed by laws and regulations, entrust a new agent to submit to the Inspection Center in a timely manner a new letter of attorney, which shall specify that the termination date of the authorization of the agent shall be the commencement date of the authorization of the new agent. | | 持有人变更代理人的，应当在完成法律法规规定的变更程序后，委托新任代理人向核查中心及时提交新的授权书，授权书应当明确即将卸任的代理人授权终止日期为新任代理人的授权开始日期。 |
| Article 11 After receiving the Basic Information Form for Products Subject to Overseas Inspection, the Inspection Center shall, according to the overall arrangement of the inspection work, preliminarily determine the inspection time and inform the holder by issuing an Advance Notice of Overseas Inspection (Annex 5). | | |
| The holder shall not delay the inspection without justifiable reasons. If it is really necessary to postpone the inspection due to special circumstances, a written application shall be submitted to the Inspection Center and an explanation shall be provided within 10 working days of receipt of the Advance Notice of Overseas Inspection. The Inspection Center will, in light of the actual conditions of the inspection work, conduct a comprehensive evaluation before determining the final inspection time provided that there is no refusal to obstruct the inspection. | | 持有人无正当理由不得推迟检查，确有特殊情况需要推迟检查的，应当在《境外检查预通知》送达后10个工作日内向核查中心提出书面申请并说明理由，经核查中心结合检查工作实际综合评估，不存在拒绝阻碍检查情形的，再确定最终检查时间。 |
Article 12 An inspection team shall, in principle, consist of more than 3 inspectors, and the team leader shall assume overall responsibility. Inspectors shall be those who have obtained the qualifications of inspectors according to law. As required for the inspection work, experts in relevant fields can be invited to participate in the inspection work.
．．．．．． | | 第十二条 检查组原则上应当由3名以上检查人员组成，检查组实行组长负责制。检查人员应当是依法取得检查员资格的人员。根据检查工作需要，可以请相关领域专家参加检查工作。
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