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| Order of the State Council of the People's Republic of China | | 中华人民共和国国务院令 |
| (No. 818) | | （第818号） |
| The Regulation on the Administration of Clinical Research on and Clinical Translational Application of New Biomedical Technologies, as adopted at the 68th executive meeting of the State Council on September 12, 2025, is hereby issued with effect from May 1, 2026. | | 《生物医学新技术临床研究和临床转化应用管理条例》已经2025年9月12日国务院第68次常务会议通过，现予公布，自2026年5月1日起施行。 |
| Li Qiang, Premier of the State Council | | 总理 李强 |
| September 28, 2025 | | 2025年9月28日 |
| Regulation on the Administration of Clinical Research on and Clinical Translational Application of New Biomedical Technologies | | 生物医学新技术临床研究和临床转化应用管理条例 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is enacted for purposes of regulating clinical research on and clinical translational application of new biomedical technologies, advancing progress and innovation in medical science and technology, ensuring the quality and safety of medical treatment, and safeguarding human dignity and health. | | 第一条 为了规范生物医学新技术临床研究和临床转化应用，促进医学科学技术进步和创新，保障医疗质量安全，维护人的尊严和健康，制定本条例。 |
| Article 2 This Regulation applies to clinical research, clinical translational application, and supervision and administration of new biomedical technologies conducted within the territory of the People's Republic of China. | | 第二条 在中华人民共和国境内从事生物医学新技术临床研究、临床转化应用及其监督管理，应当遵守本条例。 |
| Article 3 For the purpose of this Regulation, the term "new biomedical technologies" means medical techniques and measures that are based on biological principles, function at the cellular or molecular level in humans, have not been clinically applied in China, and serve to assess health status, prevent or treat diseases, or promote health. | | 第三条 本条例所称生物医学新技术，是指以对健康状态作出判断或者预防治疗疾病、促进健康为目的，运用生物学原理，作用于人体细胞、分子水平，在我国境内尚未应用于临床的医学专业手段和措施。 |
| Article 4 The conduct of clinical research on and clinical translational application of new biomedical technologies shall prioritize people's health, be guided by innovation, and maintain a proper balance between development and security. | | 第四条 开展生物医学新技术临床研究和临床转化应用应当坚持以人民健康为中心，坚持创新引领发展，坚持发展和安全并重。 |
| The state adopts measures to promote the innovative development of new biomedical technologies, and encourages and supports clinical research on and clinical translational application thereof. | | 国家采取措施促进生物医学新技术创新发展，鼓励和支持生物医学新技术临床研究和临床转化应用。 |
| Clinical research on and clinical translational application of new biomedical technologies shall be scientifically substantiated, comply with laws, administrative regulations, and relevant provisions issued by the state, and be subject to whole-process safety management controls, and shall not endanger human health, violate ethical principles, or harm public interests or national security. | | 开展生物医学新技术临床研究和临床转化应用应当具有科学依据，遵守法律、行政法规和国家有关规定，加强全过程安全管理，不得危害人体健康，不得违反伦理原则，不得损害公共利益和国家安全。 |
| Article 5 Clinical research on new biomedical technologies shall respect subjects' voluntary will, safeguard subjects' dignity, and protect subjects' lawful rights and interests. | | 第五条 开展生物医学新技术临床研究应当尊重受试者意愿，维护受试者尊严，保护受试者合法权益。 |
| Article 6 The health administration department of the State Council shall be responsible for the supervision and administration of clinical research on and clinical translational application of new biomedical technologies nationwide. | | 第六条 国务院卫生健康部门负责全国生物医学新技术临床研究和临床转化应用监督管理工作。 |
| The health departments of local people's governments at or above the county level shall be responsible for the supervision and administration of clinical research on and clinical translational application of new biomedical technologies within their respective administrative regions. | | 县级以上地方人民政府卫生健康部门负责本行政区域的生物医学新技术临床研究和临床转化应用监督管理工作。 |
| Other relevant departments of people's governments at or above the county level shall, within their respective duties, be responsible for the supervision and administration related to clinical research on and clinical translational application of new biomedical technologies. | | 县级以上人民政府其他有关部门在各自职责范围内负责与生物医学新技术临床研究和临床转化应用有关的监督管理工作。 |
| Article 7 Entities and individuals that make outstanding contributions to clinical research on and clinical translational application of new biomedical technologies shall be commended or awarded in accordance with the relevant provisions issued by the state. | | 第七条 对在生物医学新技术临床研究和临床转化应用中做出突出贡献的单位和个人，按照国家有关规定给予表彰、奖励。 |
| Chapter II Clinical Research Recordation | | 第二章 临床研究备案 |
| Article 8 For the purposes of this Regulation, "clinical research on new biomedical technologies" means activities that involve conducting trials of new biomedical technologies through any of the following approaches to evaluate their safety and effectiveness and to define their scope of application, operating procedures, and technical specifications. | | 第八条 本条例所称生物医学新技术临床研究，是指以下列方式进行生物医学新技术试验，以判断其安全性、有效性，明确其适用范围、操作流程、技术要点等的活动： |
| (1) Performing direct operations on the human body. | | （一）直接对人体进行操作的； |
| (2) Performing operations on isolated cells, tissues, or organs, followed by their implantation or transfusion into the human body. | | （二）对离体的细胞、组织、器官等进行操作，后植入或者输入人体的； |
| (3) Performing operations on human germ cells, zygotes, or embryos, followed by implantation into the human body for development. | | （三）对人的生殖细胞、合子、胚胎进行操作，后植入人体使其发育的； |
| (4) Other approaches prescribed by the health department of the State Council. | | （四）国务院卫生健康部门规定的其他方式。 |
| Article 9 Before conducting clinical research on new biomedical technologies, non-clinical research such as laboratory research and animal experiments shall be carried out in accordance with the law. Clinical research may be conducted only after the safety and effectiveness of such technologies have been demonstrated through such non-clinical research. | | 第九条 开展生物医学新技术临床研究前，应当依法开展实验室研究、动物实验等非临床研究；经非临床研究证明该技术安全、有效的，方可开展临床研究。 |
| An organization or individual may not conduct clinical research on new biomedical technologies that are expressly prohibited by laws, administrative regulations, or relevant provisions issued by the state, or that involve significant ethical issues. | | 对法律、行政法规和国家有关规定明令禁止的生物医学新技术，以及存在重大伦理问题的生物医学新技术，任何组织和个人不得开展临床研究。 |
| Article 10 An institution sponsoring clinical research on new biomedical technologies (“clinical research sponsor”) shall be a legal person lawfully established within the territory of China. | | 第十条 发起生物医学新技术临床研究的机构（以下简称临床研究发起机构）应当是在我国境内依法成立的法人。 |
| A clinical research sponsor shall ensure that the new biomedical technology proposed for clinical research has been demonstrated through non-clinical research to be safe and effective. | | 临床研究发起机构应当确保拟开展临床研究的生物医学新技术已经非临床研究证明安全、有效。 |
| Article 11 An institution conducting clinical research on new biomedical technologies (“clinical research institution”) shall meet the following conditions: | | 第十一条 实施生物医学新技术临床研究的机构（以下简称临床研究机构）应当具备下列条件： |
| (1) It shall be a Class A tertiary medical institution; | | （一）是三级甲等医疗机构； |
| (2) It shall have an academic committee and an ethics committee for clinical research that meet the required standards; | | （二）有符合要求的临床研究学术委员会和伦理委员会； |
| (3) It shall possess qualifications, premises, facilities, equipment, management bodies, professional personnel, and research capabilities commensurate with the intended clinical research on new biomedical technologies; | | （三）有与拟开展的生物医学新技术临床研究相适应的资质、场所、设施、设备、管理机构、专业技术人员和研究能力； |
| (4) It shall have management systems ensuring research quality and safety, compliance with ethical principles, and protection of the lawful rights and interests of research subjects; and | | （四）有保障临床研究质量安全、符合伦理原则以及保护受试者合法权益的管理制度； |
| (5) It shall have stable and sufficient funding sources for research. | | （五）有稳定、充足的研究经费来源。 |
| Article 12 The clinical research sponsor and the clinical research institution shall enter into a written agreement specifying their respective rights and obligations and jointly formulate a clinical research protocol. | | 第十二条 临床研究发起机构和临床研究机构应当签订书面协议，约定双方权利义务，并共同制定临床研究方案。 |
| A clinical research institution may also independently initiate clinical research on new biomedical technologies. | | 临床研究机构也可以自行发起生物医学新技术临床研究。 |
| Article 13 A clinical research institution shall appoint a principal investigator for clinical research on new biomedical technologies. The principal investigator shall hold a practicing physician qualification and a senior professional title, demonstrate sound professional ethics, research credibility, and clinical expertise, possess the professional knowledge, experience, and capability required for conducting such clinical research, and maintain the clinical research institution as his or her primary practice institution. | | 第十三条 临床研究机构应当确定生物医学新技术临床研究项目负责人。项目负责人应当具备执业医师资格和高级职称，具有良好的职业道德、科学研究信誉和临床技术水平，具备承担生物医学新技术临床研究所需的专业知识、经验和能力，并以临床研究机构为主要执业机构。 |
| Other personnel participating in clinical research on new biomedical technologies shall possess appropriate qualifications, professional knowledge, experience, and capability. | | 其他参与生物医学新技术临床研究的人员应当具备相应的资格、专业知识、经验和能力。 |
| Article 14 Both the academic committee and the ethics committee of a clinical research institution shall conduct academic and ethical reviews of the proposed clinical research as required by applicable provisions. Clinical research may be conducted only after both the academic and ethical reviews have been approved. | | 第十四条 临床研究机构的临床研究学术委员会、伦理委员会应当按照规定对拟开展的生物医学新技术临床研究进行学术审查、伦理审查；通过学术审查、伦理审查的，方可开展临床研究。 |
| Article 15 Within five working days from the date on which the clinical research on new biomedical technologies passes the academic and ethical reviews, the clinical research institution shall file for recordation with the health department of the State Council. | | 第十五条 临床研究机构应当自生物医学新技术临床研究通过学术审查、伦理审查之日起5个工作日内向国务院卫生健康部门备案。 |
| Where a clinical research sponsor initiates the same clinical research project in two or more clinical research institutions, the primary clinical research institution designated by the sponsor shall file for recordation according to the preceding paragraph. | | 临床研究发起机构在两个以上临床研究机构发起同一项生物医学新技术临床研究的，由临床研究发起机构选择的主要临床研究机构依照前款规定备案。 |
| Article 16 For the recordation of clinical research on new biomedical technologies, the following materials shall be submitted: | | 第十六条 进行生物医学新技术临床研究备案，应当提交下列资料： |
| (1) Basic information about the clinical research sponsor and clinical research institution; | | （一）临床研究发起机构、临床研究机构的基本情况； |
| (2) Basic information about the researchers; | | （二）研究人员的基本情况； |
| (3) The groundwork for the clinical research (including, among other things, summaries of scientific literature, and non-clinical research reports); | | （三）临床研究工作基础（包括科学文献总结、非临床研究报告等）； |
| (4) The clinical research protocol; | | （四）临床研究方案； |
| (5) Potential risks arising from the clinical research, as well as preventive and control measures and emergency response plans; | | （五）临床研究可能产生的风险及其预防控制措施和应急处置预案； |
| (6) Academic review opinions and ethical review opinions; | | （六）学术审查意见、伦理审查意见； |
| (7) The informed consent form (template); | | （七）知情同意书（样式）； |
| (8) Proof of the sources of research funding and plans for the use thereof; | | （八）研究经费来源证明和使用方案； |
| (9) Other materials as prescribed by the health department of the State Council. | | （九）国务院卫生健康部门规定的其他资料。 |
| The clinical research institution shall ensure that the materials submitted are true, accurate, and complete. | | 临床研究机构应当确保提交的资料真实、准确、完整。 |
| Article 17 The health department of the State Council shall make public information on clinical research on new biomedical technologies that has been filed for recordation, including the clinical research sponsor, the clinical research institution, and other relevant particulars. | | 第十七条 国务院卫生健康部门应当公布已备案的生物医学新技术临床研究及其临床研究发起机构、临床研究机构等信息。 |
| The health department of the State Council shall, in accordance with applicable provisions, organize professional institutions to evaluate clinical research on new biomedical technologies that has been filed for recordation. Where, upon evaluation, technical or ethical risks are identified, the health department of the State Council may require the clinical research institution to suspend the clinical research or modify the clinical research protocol; where major technical or ethical risks are identified, it shall require the clinical research institution to terminate the clinical research. | | 国务院卫生健康部门按照规定组织专业机构对已备案的生物医学新技术临床研究进行评估。经评估，临床研究存在技术风险或者伦理风险的，国务院卫生健康部门可以要求临床研究机构暂停临床研究、变更临床研究方案；临床研究存在重大技术风险或者重大伦理风险的，国务院卫生健康部门应当要求临床研究机构终止临床研究。 |
| Chapter III Implementation of Clinical Research | | 第三章 临床研究实施 |
| Article 18 A clinical research institution shall conduct clinical research on new biomedical technologies in accordance with the clinical research protocol that has been filed for recordation. Where it is reasonably necessary to modify the clinical research protocol, the modification shall be reviewed and approved by both the academic committee and the ethics committee, and shall be filed for recordation with the health department of the State Council within five working days from the date on which it passes the academic and ethical reviews, except for non-substantive modifications that do not involve the research objectives, research methods, primary endpoints, statistical methods, or research subjects. | | 第十八条 临床研究机构应当按照经备案的临床研究方案实施生物医学新技术临床研究。确需变更临床研究方案的，应当经临床研究学术委员会、伦理委员会审查通过，并自通过学术审查、伦理审查之日起5个工作日内向国务院卫生健康部门变更备案，但是不涉及研究目的、研究方法、主要研究终点、统计方法、受试者等的非实质性变更除外。 |
| Article 19 A clinical research institution shall obtain the written informed consent of the research subjects before conducting clinical research on new biomedical technologies. Where a research subject is a person with no capacity for civil conduct or limited capacity for civil conduct, written informed consent shall be lawfully obtained from his or her guardian. | | 第十九条 临床研究机构实施生物医学新技术临床研究，应当取得受试者的书面知情同意。受试者为无民事行为能力人或者限制民事行为能力人的，应当依法取得其监护人的书面知情同意。 |
| A clinical research institution shall inform the research subjects or their guardians, in a manner easily understandable to them, of the purpose and protocol of the clinical research, disclose the potential risks involved, and inform them of the rights and interests to which they are entitled. A clinical research institution shall not obtain consent from the research subjects or their guardians by means of deception, coercion, or undue inducement. | | 临床研究机构应当以受试者或者其监护人容易理解的方式告知其临床研究的目的、方案，披露可能产生的风险，并告知受试者享有的权益。临床研究机构不得以欺骗、胁迫或者利诱方式取得受试者或者其监护人的同意。 |
| Where a modification to the clinical research protocol may affect the rights and interests of the research subjects, the clinical research institution shall re-obtain the written informed consent from the research subjects or their guardians. | | 变更临床研究方案对受试者权益可能产生影响的，临床研究机构应当重新取得受试者或者其监护人的书面知情同意。 |
| Article 20 The clinical research sponsor and the clinical research institution shall not charge the research subject any fees related to clinical research on new biomedical technologies. | | 第二十条 临床研究发起机构、临床研究机构不得向受试者收取与生物医学新技术临床研究有关的费用。 |
| Article 21 A clinical research institution shall take measures to prevent, control, and address risks arising in the implementation of clinical research on new biomedical technologies. | | 第二十一条 临床研究机构应当采取措施，预防控制和处置生物医学新技术临床研究实施中的风险。 |
| ．．．．．． | | 生物医学新技术临床研究过程中，作用于人体的操作应当由具备相应资格的卫生专业技术人员实施；使用的药品、医疗器械应当符合《中华人民共和国药品管理法》、《医疗器械监督管理条例》等法律、行政法规规定。 |
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