KYB CHINA(2025年9月12日国务院第68次常务会议通过 2025年9月28日中华人民共和国国务院令第818号公布 自2026年5月1日起施行)
(Adopted at the 68th Executive Meeting of the State Council on September 12, 2025, promulgated by Order No. 818 of the State Council of the People's Republic of China on September 28, 2025, and effective as of May 1, 2026)
总 则
General Provisions
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。
These Regulations are formulated to regulate clinical research and clinical translation application of new biomedical technologies, promote medical science and technology progress and innovation, ensure medical quality and safety, and safeguard human dignity and health.
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。
The clinical research, clinical translation application, and their supervision and management of new biomedical technologies conducted within the territory of the People's Republic of China shall comply with these Regulations.
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。
For the purposes of these Regulations, 'new biomedical technologies' refer to medical professional means and measures that, for the purpose of making judgments on health status, preventing or treating diseases, or promoting health, apply biological principles, act on human cells or molecular levels, and have not yet been applied clinically within China.
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 conduct of clinical research and clinical translation application of new biomedical technologies shall adhere to a people-centered health approach, insist on innovation-driven development, and balance development and safety.
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。
The State shall take measures to promote the innovative development of new biomedical technologies and encourage and support clinical research and clinical translation application of new biomedical technologies.
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。
Clinical research and clinical translation application of new biomedical technologies shall have a scientific basis, comply with laws, administrative regulations, and relevant state provisions, strengthen whole-process safety management, and shall not harm human health, violate ethical principles, or harm public interests and national security.
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。
Clinical research of new biomedical technologies shall respect the will of subjects, safeguard their dignity, and protect their lawful rights and interests.
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 department of the State Council shall be responsible for the supervision and management of clinical research and clinical translation application of new biomedical technologies nationwide.
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。
The health departments of local people's governments at or above the county level shall be responsible for the supervision and management of clinical research and clinical translation application of new biomedical technologies within their respective administrative regions.
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。
Other relevant departments of the people's governments at or above the county level shall, within their respective duties, be responsible for the supervision and management related to clinical research and clinical translation application of new biomedical technologies.
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。
Units and individuals that have made outstanding contributions to clinical research and clinical translation application of new biomedical technologies shall be commended and rewarded in accordance with relevant state provisions.
临床研究备案
Filing of Clinical Research
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：
For the purposes of these Regulations, 'clinical research of new biomedical technologies' refers to activities that test new biomedical technologies in the following ways to determine their safety and efficacy, and to clarify their scope of application, operational procedures, technical points, etc.:
(一)直接对人体进行操作的；
(1) Directly operating on 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；
(2) Operating on isolated cells, tissues, organs, etc., and then implanting or infusing them into the human body;
(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；
(3) Operating on human germ cells, zygotes, or embryos, and then implanting them into the human body for development;
(四)国务院卫生健康部门规定的其他方式。
(4) Other methods prescribed by the health department of the State Council.
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。
Before conducting clinical research of new biomedical technologies, non-clinical research such as laboratory research and animal experiments shall be conducted in accordance with the law; clinical research may only be conducted after non-clinical research has proven the technology to be safe and effective.
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。
No organization or individual may conduct clinical research on new biomedical technologies that are explicitly prohibited by laws, administrative regulations, and relevant state provisions, or that have major ethical issues.
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。
The institution that initiates clinical research of new biomedical technologies (hereinafter referred to as the clinical research sponsor) shall be a legal person established in accordance with the law within China.
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。
The clinical research sponsor shall ensure that the new biomedical technology to be clinically researched has been proven safe and effective through non-clinical research.
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：
The institution that implements clinical research of new biomedical technologies (hereinafter referred to as the clinical research institution) shall meet the following conditions:
(一)是三级甲等医疗机构；
(1) It is a tertiary Grade A medical institution;
(二)有符合要求的临床研究学术委员会和伦理委员会；
(2) It has a qualified clinical research academic committee and ethics committee;
(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；
(3) It has the qualifications, premises, facilities, equipment, management institutions, professional technical personnel, and research capabilities appropriate for the proposed clinical research of new biomedical technologies;
(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；
(4) It has management systems to ensure the quality and safety of clinical research, compliance with ethical principles, and protection of the lawful rights and interests of subjects;
(五)有稳定、充足的研究经费来源。
(5) It has stable and sufficient research funding sources.
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。
The clinical research sponsor and the clinical research institution shall sign a written agreement specifying the rights and obligations of both parties and jointly formulate the clinical research protocol.
临床研究机构也可以自行发起生物医学新技术临床研究。
A clinical research institution may also initiate clinical research of new biomedical technologies on its own.
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。
The clinical research institution shall designate a project leader for the clinical research of new biomedical technologies. The project leader shall hold a medical practitioner qualification and a senior professional title, have good professional ethics, scientific research reputation, and clinical technical ability, possess the professional knowledge, experience, and ability required to undertake the clinical research of new biomedical technologies, and take the clinical research institution as the main practice institution.
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。
Other personnel participating in the clinical research of new biomedical technologies shall have the corresponding qualifications, professional knowledge, experience, and ability.
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。
The clinical research academic committee and ethics committee of the clinical research institution shall conduct academic review and ethical review of the proposed clinical research of new biomedical technologies in accordance with regulations; clinical research may only be conducted after passing the academic review and ethical review.
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。
The clinical research institution shall file with the health department of the State Council within 5 working days from the date the clinical research of new biomedical technologies passes the academic review and ethical review.
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。
If a clinical research sponsor initiates the same clinical research of new biomedical technologies at two or more clinical research institutions, the main clinical research institution selected by the clinical research sponsor shall file in accordance with the preceding paragraph.
进行生物医学新技术临床研究备案，应当提交下列资料：
To file clinical research of new biomedical technologies, the following materials shall be submitted:
(一)临床研究发起机构、临床研究机构的基本情况；
(1) Basic information of the clinical research sponsor and clinical research institution;
(二)研究人员的基本情况；
(2) Basic information of the researchers;
(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)；
(3) Basis for clinical research work (including scientific literature summary, non-clinical research reports, etc.);
(四)临床研究方案；
(4) Clinical research protocol;
(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；
(5) Potential risks of the clinical research and their prevention, control measures, and emergency response plans;
(六)学术审查意见、伦理审查意见；
(6) Academic review opinion and ethical review opinion;
(七)知情同意书(样式)；
(7) Informed consent form (template);
(八)研究经费来源证明和使用方案；
(8) Proof of research funding sources and usage plan;
(九)国务院卫生健康部门规定的其他资料。
(9) Other materials prescribed by the health department of the State Council.
临床研究机构应当确保提交的资料真实、准确、完整。
The clinical research institution shall ensure that the submitted materials are true, accurate, and complete.
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 publish information on filed clinical research of new biomedical technologies, including the clinical research sponsor and clinical research institution.
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。
The health department of the State Council shall, in accordance with regulations, organize professional institutions to evaluate the filed clinical research of new biomedical technologies. If the evaluation finds that the clinical research has technical risks or ethical risks, the health department of the State Council may require the clinical research institution to suspend the clinical research or modify the clinical research protocol; if the clinical research has major technical risks or major ethical risks, the health department of the State Council shall require the clinical research institution to terminate the clinical research.
临床研究实施
Implementation of Clinical Research
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。
The clinical research institution shall implement the clinical research of new biomedical technologies in accordance with the filed clinical research protocol. If the clinical research protocol needs to be modified, it shall be reviewed and approved by the clinical research academic committee and ethics committee, and the modification shall be filed with the health department of the State Council within 5 working days from the date of passing the academic review and ethical review, except for non-substantive modifications that do not involve the research purpose, research methods, primary endpoints, statistical methods, subjects, etc.
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。
The clinical research institution shall obtain written informed consent from the subject before implementing clinical research of new biomedical technologies. If the subject is a person without civil capacity or with limited civil capacity, written informed consent shall be obtained from the subject's guardian in accordance with the law.
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。
The clinical research institution shall inform the subject or their guardian in an easily understandable manner of the purpose and protocol of the clinical research, disclose potential risks, and inform the subject of their rights. The clinical research institution shall not obtain consent from the subject or their guardian by deception, coercion, or inducement.
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。
If a modification to the clinical research protocol may affect the rights and interests of the subject, the clinical research institution shall re-obtain written informed consent from the subject or their guardian.
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。
The clinical research sponsor and clinical research institution shall not charge subjects any fees related to the clinical research of new biomedical technologies.
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。
The clinical research institution shall take measures to prevent, control, and manage risks during the implementation of clinical research of new biomedical technologies.
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。
During the clinical research of new biomedical technologies, operations on the human body shall be performed by health professionals with appropriate qualifications; the drugs and medical devices used shall comply with the provisions of the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, and other laws and administrative regulations.
临床研究机构应当及时、准确、完整记录生物医学新技术临床研究实施情况，留存相关原始材料。记录和原始材料应当自临床研究结束起保存30年；临床研究涉及子代的，记录和原始材料应当永久保存。
The clinical research institution shall timely, accurately, and completely record the implementation of clinical research of new biomedical technologies and retain relevant original materials. Records and original materials shall be preserved for 30 years from the end of the clinical research; if the clinical research involves offspring, records and original materials shall be preserved permanently.
临床研究发起机构、临床研究机构不得伪造、篡改、隐匿生物医学新技术临床研究记录和原始材料。
The clinical research sponsor and clinical research institution shall not forge, tamper with, or conceal records and original materials of clinical research of new biomedical technologies.
临床研究机构需要其他机构为其实施生物医学新技术临床研究提供技术支持，提供人体细胞、组织、器官等生物样本，或者协助招募受试者的，应当告知临床研究的目的、方案、备案情况和生物样本的用途。
If a clinical research institution requires other institutions to provide technical support for implementing clinical research of new biomedical technologies, provide biological samples such as human cells, tissues, or organs, or assist in recruiting subjects, it shall inform them of the purpose, protocol, filing status of the clinical research, and the intended use of the biological samples.
临床研究机构应当定期向国务院卫生健康部门报告生物医学新技术临床研究实施情况。
The clinical research institution shall regularly report to the health department of the State Council on the implementation of clinical research of new biomedical technologies.
有下列情形之一的，临床研究机构应当终止生物医学新技术临床研究，于5个工作日内向国务院卫生健康部门报告，并告知临床研究发起机构：
In any of the following circumstances, the clinical research institution shall terminate the clinical research of new biomedical technologies, report to the health department of the State Council within 5 working days, and inform the clinical research sponsor:
(一)发现生物医学新技术的安全性、有效性存在重大问题；
(1) Major issues are found regarding the safety or efficacy of the new biomedical technology;
(二)临床研究产生或者可能产生重大社会不良影响；
(2) The clinical research has caused or may cause significant adverse social impact;
(三)临床研究过程中出现不可控制的风险；
(3) Uncontrollable risks arise during the clinical research;
(四)国务院卫生健康部门规定的其他情形。
(4) Other circumstances prescribed by the health department of the State Council.
生物医学新技术临床研究过程中发生严重不良反应的，临床研究机构应当暂停临床研究，由临床研究伦理委员会就是否可以继续实施临床研究进行评估。临床研究机构应当根据评估意见终止临床研究或者继续实施临床研究，于5个工作日内向国务院卫生健康部门报告，并告知临床研究发起机构。
If a serious adverse reaction occurs during the clinical research of new biomedical technologies, the clinical research institution shall suspend the clinical research, and the clinical research ethics committee shall evaluate whether the clinical research can continue. The clinical research institution shall terminate or continue the clinical research based on the evaluation opinion, report to the health department of the State Council within 5 working days, and inform the clinical research sponsor.
生物医学新技术临床研究结束后，临床研究机构应当向国务院卫生健康部门报告临床研究实施情况、研究结果和临床转化应用建议。临床研究机构应当对受试者进行随访监测，评价生物医学新技术的长期安全性、有效性。
After the completion of clinical research of new biomedical technologies, the clinical research institution shall report to the health department of the State Council on the implementation, research results, and recommendations for clinical translation application. The clinical research institution shall conduct follow-up monitoring of subjects to evaluate the long-term safety and efficacy of the new biomedical technology.
生物医学新技术临床研究造成受试者健康损害的，临床研究机构应当及时予以治疗，治疗费用由临床研究发起机构承担；但是，因临床研究机构过错造成受试者健康损害的，治疗费用由临床研究机构承担。
If clinical research of new biomedical technologies causes harm to the health of a subject, the clinical research institution shall provide timely treatment, and the treatment costs shall be borne by the clinical research sponsor; however, if the harm is caused by the fault of the clinical research institution, the treatment costs shall be borne by the clinical research institution.
鼓励临床研究发起机构、临床研究机构通过购买商业保险为受试者提供相应的保障。
Clinical research sponsors and clinical research institutions are encouraged to purchase commercial insurance to provide corresponding protection for subjects.
临床研究发起机构、临床研究机构以及其他与生物医学新技术临床研究有关的机构应当依法保护受试者的个人隐私、个人信息。
The clinical research sponsor, clinical research institution, and other institutions related to the clinical research of new biomedical technologies shall protect the personal privacy and personal information of subjects in accordance with the law.
临床转化应用
Clinical Translation Application
生物医学新技术临床研究结束后拟转化应用于临床的，应当经国务院卫生健康部门审查批准。
If a new biomedical technology is to be translated into clinical application after the completion of clinical research, it shall be reviewed and approved by the health department of the State Council.
生物医学新技术拟转化应用于临床的，临床研究发起机构应当向国务院卫生健康部门提出申请，并提交下列资料：
If a new biomedical technology is to be translated into clinical application, the clinical research sponsor shall submit an application to the health department of the State Council and provide the following materials:
(一)生物医学新技术临床研究报告和记录；
(1) Clinical research report and records of the new biomedical technology;
(二)生物医学新技术的适用范围、可能出现的不良反应和禁忌；
(2) Scope of application, possible adverse reactions, and contraindications of the new biomedical technology;
(三)应用生物医学新技术的医疗机构、卫生专业技术人员需要具备的条件；
(3) Conditions that medical institutions and health professionals applying the new biomedical technology need to meet;
(四)临床应用操作规范；
(4) Clinical application operation specifications;
(五)临床应用中可能产生的风险及其预防控制措施；
(5) Potential risks during clinical application and their prevention and control measures;
(六)国务院卫生健康部门规定的其他资料。
(6) Other materials prescribed by the health department of the State Council.
临床研究发起机构应当确保提交的资料真实、准确、完整。
The clinical research sponsor shall ensure that the submitted materials are true, accurate, and complete.
国务院卫生健康部门应当自受理生物医学新技术临床转化应用申请之日起5个工作日内将申请资料转交专业机构进行技术评估、伦理评估，并自收到评估意见之日起15个工作日内作出决定。对临床研究证明安全、有效，且符合伦理原则的，予以批准；对不符合上述要求的，不予批准，并书面说明理由。
The health department of the State Council shall, within 5 working days from the date of accepting an application for clinical translation application of new biomedical technologies, forward the application materials to a professional institution for technical evaluation and ethical evaluation, and shall make a decision within 15 working days from the date of receiving the evaluation opinion. If the clinical research proves the technology to be safe and effective and it complies with ethical principles, approval shall be granted; if it does not meet the above requirements, approval shall be denied, with a written explanation of the reasons.
生物医学新技术临床转化应用申请审查工作规范以及技术评估、伦理评估工作规则，由国务院卫生健康部门制定。
The work specifications for reviewing applications for clinical translation application of new biomedical technologies and the rules for technical evaluation and ethical evaluation shall be formulated by the health department of the State Council.
对治疗严重危及生命且尚无有效治疗手段的疾病以及公共卫生方面急需的生物医学新技术的临床转化应用申请，国务院卫生健康部门应当予以优先审查审批。
Applications for clinical translation application of new biomedical technologies that treat diseases that are seriously life-threatening and for which there is no effective treatment, as well as those urgently needed for public health, shall be given priority review and approval by the health department of the State Council.
国务院卫生健康部门批准生物医学新技术临床转化应用的，应当公布技术名称、应用该技术的医疗机构和卫生专业技术人员应当具备的条件以及临床应用操作规范。
If the health department of the State Council approves the clinical translation application of a new biomedical technology, it shall publish the technology name, the conditions that medical institutions and health professionals applying the technology must meet, and the clinical application operation specifications.
对经批准临床转化应用的生物医学新技术，医疗机构开展临床应用的，应当具备国务院卫生健康部门规定的条件。医疗机构及其医务人员应当遵守该技术的临床应用操作规范，保障医疗质量安全，预防控制风险。医疗机构开展临床应用可以按照规定收取费用。
For new biomedical technologies approved for clinical translation application, medical institutions that carry out clinical application shall meet the conditions prescribed by the health department of the State Council. Medical institutions and their medical personnel shall comply with the clinical application operation specifications of the technology, ensure medical quality and safety, and prevent and control risks. Medical institutions may charge fees for clinical application in accordance with regulations.
医疗机构应当按照国务院卫生健康部门的规定向所在地省、自治区、直辖市人民政府卫生健康部门报告经批准临床转化应用的生物医学新技术临床应用情况。临床应用过程中发生严重不良反应或者医疗事故的，医疗机构应当按照规定进行处理。
Medical institutions shall, in accordance with the provisions of the health department of the State Council, report to the health department of the provincial, autonomous region, or municipality directly under the Central Government where they are located on the clinical application of new biomedical technologies approved for clinical translation application. If a serious adverse reaction or medical accident occurs during clinical application, the medical institution shall handle it in accordance with regulations.
为应对特别重大突发公共卫生事件或者其他严重威胁公众健康的紧急事件，国务院卫生健康部门经组织论证确有必要的，可以同意在一定范围和期限内紧急应用正在开展临床研究的生物医学新技术。
To respond to particularly major public health emergencies or other emergency events that seriously threaten public health, the health department of the State Council may, after organizing demonstration and deeming it necessary, agree to the emergency application of new biomedical technologies that are undergoing clinical research within a certain scope and period.
经批准临床转化应用的生物医学新技术有下列情形之一的，国务院卫生健康部门应当对其安全性、有效性进行再评估，再评估期间暂停临床应用该技术：
If a new biomedical technology approved for clinical translation application falls under any of the following circumstances, the health department of the State Council shall conduct a re-evaluation of its safety and efficacy, and suspend the clinical application of the technology during the re-evaluation period:
(一)根据科学研究的发展，对该技术的安全性、有效性有认识上的改变；
(1) There is a change in understanding of the safety or efficacy of the technology based on scientific research developments;
(二)临床应用过程中发生严重不良反应或者出现不可控制的风险；
(2) A serious adverse reaction occurs during clinical application or uncontrollable risks arise;
(三)国务院卫生健康部门规定的其他情形。
(3) Other circumstances prescribed by the health department of the State Council.
经评估不能保证安全、有效的，国务院卫生健康部门应当决定禁止临床应用该技术。
If the evaluation cannot ensure safety and efficacy, the health department of the State Council shall decide to prohibit the clinical application of the technology.
监 督 管 理
Supervision and Management
县级以上人民政府卫生健康部门应当对生物医学新技术临床研究和临床转化应用进行监督检查；发现违反本条例规定行为的，应当依法处理。
The health departments of the people's governments at or above the county level shall conduct supervision and inspection of clinical research and clinical translation application of new biomedical technologies; if violations of these Regulations are found, they shall be dealt with in accordance with the law.
县级以上人民政府卫生健康部门进行监督检查时，可以采取下列措施：
When conducting supervision and inspection, the health departments of the people's governments at or above the county level may take the following measures:
(一)进入生物医学新技术临床研究或者临床应用场所实施现场检查；
(1) Enter the site where clinical research or clinical application of new biomedical technologies is conducted for on-site inspection;
(二)查阅、复制有关记录、病历、协议、票据、账簿等资料；
(2) Review and copy relevant records, medical records, agreements, invoices, account books, and other materials;
(三)查封、扣押涉嫌用于违法开展生物医学新技术临床研究或者临床应用的设备、药品、医疗器械等物品；
(3) Seal up or seize equipment, drugs, medical devices, and other items suspected of being used for illegal clinical research or clinical application of new biomedical technologies;
(四)查封涉嫌违法开展生物医学新技术临床研究或者临床应用的场所、设施。
(4) Seal up sites and facilities suspected of being used for illegal clinical research or clinical application of new biomedical technologies.
被检查单位对监督检查应当予以配合，不得拒绝、隐瞒。
The inspected unit shall cooperate with the supervision and inspection and shall not refuse or conceal.
科研机构、教育机构等临床研究发起机构的主管部门应当加强对临床研究发起机构的管理，配合卫生健康部门开展涉及生物医学新技术的监督检查，发现违反本条例规定行为的，应当及时通报同级卫生健康部门。
The competent departments of clinical research sponsors such as scientific research institutions and educational institutions shall strengthen the management of clinical research sponsors, cooperate with health departments in conducting supervision and inspection involving new biomedical technologies, and if violations of these Regulations are found, shall promptly notify the health department at the same level.
国务院卫生健康部门建立生物医学新技术临床研究和临床转化应用在线服务系统，为临床研究发起机构、临床研究机构等进行备案、申请行政许可、报告信息等提供便利。县级以上人民政府卫生健康部门应当通过在线服务系统及时公布备案、行政许可、监督检查、违法行为查处等监督管理信息。
The health department of the State Council shall establish an online service system for clinical research and clinical translation application of new biomedical technologies to facilitate filing, application for administrative permits, and information reporting by clinical research sponsors and clinical research institutions. The health departments of the people's governments at or above the county level shall promptly publish supervision and management information such as filing, administrative permits, supervision and inspection, and investigation and punishment of illegal acts through the online service system.
国务院卫生健康部门指导专业机构加强能力建设，提高评估的专业化水平。
The health department of the State Council shall guide professional institutions to strengthen capacity building and improve the professional level of evaluation.
县级以上人民政府卫生健康部门应当公布本部门的电子邮件地址、电话，接受投诉、举报，并及时处理。对查证属实的举报，按照国家有关规定给予举报人奖励。
The health departments of the people's governments at or above the county level shall publish their email addresses and telephone numbers, accept complaints and reports, and handle them promptly. For verified reports, the whistleblower shall be rewarded in accordance with relevant state provisions.
县级以上人民政府卫生健康部门应当对举报人的信息予以保密，保护举报人的合法权益。
The health departments of the people's governments at or above the county level shall keep the information of whistleblowers confidential and protect their lawful rights and interests.
法 律 责 任
Legal Liability
违反本条例第九条第二款规定，开展禁止开展的生物医学新技术临床研究，或者将上述禁止开展临床研究的生物医学新技术应用于临床的，由县级以上人民政府卫生健康部门责令停止违法行为，没收违法所得和有关资料、物品，没有违法所得或者违法所得不足100万元的，处100万元以上1000万元以下罚款，违法所得100万元以上的，处违法所得10倍以上20倍以下罚款，5年内禁止其开展生物医学新技术临床研究，并可以由原执业登记部门吊销医疗机构执业许可证或者由原备案部门责令停止执业活动；对负有责任的领导人员和直接责任人员，依法给予处分，处10万元以上20万元以下罚款，10年直至终身禁止其从事生物医学新技术临床研究，并由原执业注册部门吊销有关医务人员的执业证书。
Whoever, in violation of the second paragraph of Article 9, conducts clinical research on prohibited new biomedical technologies, or applies such prohibited new biomedical technologies to clinical use, shall be ordered by the health department of the people's government at or above the county level to cease the illegal act, confiscate the illegal gains and relevant materials and articles; if there are no illegal gains or the illegal gains are less than 1 million yuan, a fine of not less than 1 million yuan but not more than 10 million yuan shall be imposed; if the illegal gains are 1 million yuan or more, a fine of not less than 10 times but not more than 20 times the illegal gains shall be imposed; the entity shall be prohibited from conducting clinical research of new biomedical technologies for 5 years, and the original practice registration department may revoke the medical institution's practice license or the original filing department may order the cessation of practice activities; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 10 years to life, and the original practice registration department shall revoke the practice certificates of the relevant medical personnel.
有下列情形之一的，由县级以上人民政府卫生健康部门责令停止违法行为，没收违法所得和有关资料、物品，没有违法所得或者违法所得不足100万元的，处50万元以上500万元以下罚款，违法所得100万元以上的，处违法所得5倍以上10倍以下罚款，3年内禁止其开展生物医学新技术临床研究，并可以由原执业登记部门吊销医疗机构执业许可证或者由原备案部门责令停止执业活动；对负有责任的领导人员和直接责任人员，依法给予处分，处2万元以上10万元以下罚款，5年内禁止其从事生物医学新技术临床研究，并由原执业注册部门吊销有关医务人员的执业证书：
In any of the following circumstances, the health department of the people's government at or above the county level shall order the cessation of the illegal act, confiscate the illegal gains and relevant materials and articles; if there are no illegal gains or the illegal gains are less than 1 million yuan, a fine of not less than 500,000 yuan but not more than 5 million yuan shall be imposed; if the illegal gains are 1 million yuan or more, a fine of not less than 5 times but not more than 10 times the illegal gains shall be imposed; the entity shall be prohibited from conducting clinical research of new biomedical technologies for 3 years, and the original practice registration department may revoke the medical institution's practice license or the original filing department may order the cessation of practice activities; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 20,000 yuan but not more than 100,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 5 years, and the original practice registration department shall revoke the practice certificates of the relevant medical personnel:
(一)对未经非临床研究证明安全、有效的生物医学新技术开展临床研究；
(1) Conducting clinical research on new biomedical technologies that have not been proven safe and effective through non-clinical research;
(二)未通过学术审查、伦理审查，开展生物医学新技术临床研究；
(2) Conducting clinical research of new biomedical technologies without passing academic review and ethical review;
(三)将未经批准临床转化应用的生物医学新技术应用于临床。
(3) Applying new biomedical technologies that have not been approved for clinical translation application to clinical use.
不符合本条例第十条第一款、第十一条规定开展生物医学新技术临床研究的，由县级以上人民政府卫生健康部门责令停止临床研究，没收违法所得和有关资料、物品，处20万元以上100万元以下罚款，2年内禁止其开展生物医学新技术临床研究；对负有责任的领导人员和直接责任人员，依法给予处分，处1万元以上5万元以下罚款，3年内禁止其从事生物医学新技术临床研究。
Whoever conducts clinical research of new biomedical technologies without meeting the requirements of Article 10, paragraph 1, and Article 11 of these Regulations shall be ordered by the health department of the people's government at or above the county level to cease the clinical research, confiscate the illegal gains and relevant materials and articles, and impose a fine of not less than 200,000 yuan but not more than 1 million yuan; the entity shall be prohibited from conducting clinical research of new biomedical technologies for 2 years; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 3 years.
开展生物医学新技术临床研究未依照本条例规定备案的，由县级以上人民政府卫生健康部门责令限期备案；逾期未备案的，依照前款规定予以处罚。
Whoever conducts clinical research of new biomedical technologies without filing in accordance with these Regulations shall be ordered by the health department of the people's government at or above the county level to file within a specified period; if the filing is not made within the specified period, punishment shall be imposed in accordance with the preceding paragraph.
有下列情形之一的，由县级以上人民政府卫生健康部门责令停止生物医学新技术临床研究，处10万元以上50万元以下罚款；对负有责任的领导人员和直接责任人员，依法给予处分，处1万元以上3万元以下罚款，2年内禁止其从事生物医学新技术临床研究，并对有关医务人员责令暂停6个月以上1年以下执业活动直至由原执业注册部门吊销执业证书：
In any of the following circumstances, the health department of the people's government at or above the county level shall order the cessation of the clinical research of new biomedical technologies, and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 2 years, and the relevant medical personnel shall be ordered to suspend practice for not less than 6 months but not more than 1 year, or their practice certificates shall be revoked by the original practice registration department:
(一)临床研究机构未按照国务院卫生健康部门的要求暂停生物医学新技术临床研究、变更临床研究方案，或者未按照国务院卫生健康部门的要求终止临床研究；
(1) The clinical research institution fails to suspend the clinical research of new biomedical technologies, modify the clinical research protocol, or terminate the clinical research as required by the health department of the State Council;
(二)临床研究机构未依照本条例第十九条规定取得受试者或者其监护人书面知情同意实施生物医学新技术临床研究；
(2) The clinical research institution implements clinical research of new biomedical technologies without obtaining written informed consent from the subject or their guardian in accordance with Article 19 of these Regulations;
(三)临床研究发起机构、临床研究机构伪造、篡改、隐匿生物医学新技术临床研究记录、原始材料；
(3) The clinical research sponsor or clinical research institution forges, tampers with, or conceals records or original materials of clinical research of new biomedical technologies;
(四)临床研究机构未依照本条例第二十五条规定终止生物医学新技术临床研究。
(4) The clinical research institution fails to terminate the clinical research of new biomedical technologies in accordance with Article 25 of these Regulations.
有下列情形之一的，由县级以上人民政府卫生健康部门责令限期改正，处5万元以上20万元以下罚款，并可以责令暂停生物医学新技术临床研究；情节严重的，责令停止临床研究，处20万元以上50万元以下罚款，对负有责任的领导人员和直接责任人员，依法给予处分，处1万元以上3万元以下罚款，2年内禁止其从事生物医学新技术临床研究：
In any of the following circumstances, the health department of the people's government at or above the county level shall order correction within a specified period, impose a fine of not less than 50,000 yuan but not more than 200,000 yuan, and may order the suspension of the clinical research of new biomedical technologies; if the circumstances are serious, the clinical research shall be ordered to cease, and a fine of not less than 200,000 yuan but not more than 500,000 yuan shall be imposed; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 2 years:
(一)临床研究机构未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，但是属于临床研究方案非实质性变更的除外；
(1) The clinical research institution fails to implement the clinical research of new biomedical technologies in accordance with the filed clinical research protocol, except for non-substantive modifications to the clinical research protocol;
(二)临床研究机构未依照本条例第二十一条第一款规定采取风险预防控制、处置措施；
(2) The clinical research institution fails to take risk prevention, control, and management measures in accordance with Article 21, paragraph 1 of these Regulations;
(三)临床研究机构违反本条例第二十一条第二款规定，安排不具备相应资格的人员实施作用于人体的操作；
(3) The clinical research institution, in violation of Article 21, paragraph 2 of these Regulations, arranges personnel without appropriate qualifications to perform operations on the human body;
(四)临床研究机构未依照本条例第二十七条第一款规定对受试者进行治疗，或者有其他损害受试者合法权益的行为。
(4) The clinical research institution fails to provide treatment to the subject in accordance with Article 27, paragraph 1 of these Regulations, or otherwise infringes upon the lawful rights and interests of the subject.
有下列情形之一的，由县级以上人民政府卫生健康部门责令限期改正，并可以责令暂停生物医学新技术临床研究；情节严重的，责令停止临床研究，对负有责任的领导人员和直接责任人员，依法给予处分：
In any of the following circumstances, the health department of the people's government at or above the county level shall order correction within a specified period and may order the suspension of the clinical research of new biomedical technologies; if the circumstances are serious, the clinical research shall be ordered to cease, and the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law:
(一)临床研究机构未依照本条例第二十二条第一款规定记录临床研究实施情况、留存原始材料；
(1) The clinical research institution fails to record the implementation of clinical research or retain original materials in accordance with Article 22, paragraph 1 of these Regulations;
(二)临床研究机构未依照本条例第二十三条规定告知有关事项；
(2) The clinical research institution fails to inform relevant matters in accordance with Article 23 of these Regulations;
(三)临床研究机构未依照本条例第二十四条规定报告临床研究实施情况。
(3) The clinical research institution fails to report the implementation of clinical research in accordance with Article 24 of these Regulations.
临床研究机构未依照本条例第二十五条、第二十六条规定报告，或者医疗机构未依照本条例第三十五条规定报告的，由县级以上人民政府卫生健康部门责令限期改正；逾期未改正的，处2万元以上5万元以下罚款。
If the clinical research institution fails to report in accordance with Articles 25 and 26 of these Regulations, or if the medical institution fails to report in accordance with Article 35 of these Regulations, the health department of the people's government at or above the county level shall order correction within a specified period; if correction is not made within the specified period, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed.
临床研究发起机构、临床研究机构向受试者收取与生物医学新技术临床研究有关的费用的，由县级以上人民政府市场监督管理部门责令退还，处违法收取的费用5倍以下罚款；情节严重的，责令停业整顿。
If the clinical research sponsor or clinical research institution charges subjects fees related to the clinical research of new biomedical technologies, the market supervision and management department of the people's government at or above the county level shall order the return of the fees and impose a fine of not more than 5 times the illegally charged fees; if the circumstances are serious, the entity shall be ordered to suspend business for rectification.
不具备国务院卫生健康部门规定条件的医疗机构开展经批准临床转化应用的生物医学新技术临床应用的，由县级以上人民政府卫生健康部门责令停止临床应用，没收违法所得，并处10万元以上50万元以下罚款；情节严重的，并处50万元以上100万元以下罚款。
If a medical institution that does not meet the conditions prescribed by the health department of the State Council carries out clinical application of new biomedical technologies approved for clinical translation application, the health department of the people's government at or above the county level shall order the cessation of the clinical application, confiscate the illegal gains, and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan; if the circumstances are serious, a fine of not less than 500,000 yuan but not more than 1 million yuan shall also be imposed.
临床研究发起机构申请生物医学新技术临床转化应用许可时提供虚假资料或者采用其他欺骗手段的，不予受理或者不予行政许可，已经取得行政许可的，由国务院卫生健康部门撤销行政许可，没收违法所得，处违法所得5倍以上10倍以下罚款，3年内禁止其开展生物医学新技术临床研究；对负有责任的领导人员和直接责任人员，依法给予处分，处2万元以上10万元以下罚款，5年内禁止其从事生物医学新技术临床研究。
If a clinical research sponsor provides false materials or uses other deceptive means when applying for a permit for clinical translation application of new biomedical technologies, the application shall not be accepted or the administrative permit shall not be granted; if the administrative permit has already been granted, the health department of the State Council shall revoke the administrative permit, confiscate the illegal gains, impose a fine of not less than 5 times but not more than 10 times the illegal gains, and prohibit the entity from conducting clinical research of new biomedical technologies for 3 years; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 20,000 yuan but not more than 100,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 5 years.
临床研究机构在生物医学新技术临床研究备案中提供虚假资料或者采用其他欺骗手段的，由国务院卫生健康部门责令停止临床研究，没收违法所得和有关资料、物品，处违法所得2倍以上5倍以下罚款，2年内禁止其开展生物医学新技术临床研究；对负有责任的领导人员和直接责任人员，依法给予处分，处1万元以上5万元以下罚款，3年内禁止其从事生物医学新技术临床研究。
If a clinical research institution provides false materials or uses other deceptive means in the filing of clinical research of new biomedical technologies, the health department of the State Council shall order the cessation of the clinical research, confiscate the illegal gains and relevant materials and articles, impose a fine of not less than 2 times but not more than 5 times the illegal gains, and prohibit the entity from conducting clinical research of new biomedical technologies for 2 years; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; they shall be prohibited from engaging in clinical research of new biomedical technologies for 3 years.
专业机构在评估中出具虚假评估意见的，由县级以上人民政府卫生健康部门处10万元以上50万元以下罚款，3年内禁止其参与生物医学新技术相关评估工作；对负有责任的领导人员和直接责任人员，依法给予处分，处1万元以上5万元以下罚款，5年内禁止其参与生物医学新技术相关评估工作。
If a professional institution issues a false evaluation opinion in an evaluation, the health department of the people's government at or above the county level shall impose a fine of not less than 100,000 yuan but not more than 500,000 yuan, and prohibit the institution from participating in evaluation work related to new biomedical technologies for 3 years; the responsible leaders and directly responsible personnel shall be given sanctions in accordance with the law, and a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; they shall be prohibited from participating in evaluation work related to new biomedical technologies for 5 years.
卫生健康等部门工作人员违反本条例规定，滥用职权、玩忽职守、徇私舞弊的，依法给予处分。
If staff members of the health department or other departments violate these Regulations by abusing their power, neglecting their duties, or engaging in malpractice for personal gain, they shall be given sanctions in accordance with the law.
违反本条例规定，造成人身、财产损害的，依法承担民事责任；构成犯罪的，依法追究刑事责任。
Whoever violates these Regulations and causes personal or property damage shall bear civil liability in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
附 则
Supplementary Provisions
为研制药品、医疗器械开展临床试验的，依照《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、行政法规规定执行。
Clinical trials conducted for the development of drugs and medical devices shall be implemented in accordance with the provisions of the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, and other laws and administrative regulations.
国务院卫生健康部门会同国务院药品监督管理部门根据科学技术的发展，制定、调整生物医学新技术与药品、医疗器械的界定指导原则。
The health department of the State Council, in conjunction with the drug regulatory department of the State Council, shall, based on scientific and technological developments, formulate and adjust guiding principles for the definition of new biomedical technologies and drugs and medical devices.
军队医疗机构开展生物医学新技术临床研究和临床转化应用，由中央军委机关有关部门参照本条例规定进行监督管理。
The clinical research and clinical translation application of new biomedical technologies conducted by military medical institutions shall be supervised and managed by the relevant departments of the Central Military Commission with reference to these Regulations.
本条例施行前已经开展的生物医学新技术临床研究，临床研究机构可以按照临床研究方案继续实施，并应当自本条例施行之日起1个月内依照本条例规定进行备案。
For clinical research of new biomedical technologies that has already been initiated before the effective date of these Regulations, the clinical research institution may continue to implement it according to the clinical research protocol, and shall file in accordance with these Regulations within 1 month from the effective date of these Regulations.
本条例自2026年5月1日起施行。
These Regulations shall come into effect on May 1, 2026.