KYB CHINA(2019年5月28日中华人民共和国国务院令第717号公布 根据2024年3月10日《国务院关于修改和废止部分行政法规的决定》修订)
(Promulgated by Decree No. 717 of the State Council of the People's Republic of China on May 28, 2019; amended in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 10, 2024)
总 则
General Provisions
为了有效保护和合理利用我国人类遗传资源，维护公众健康、国家安全和社会公共利益，制定本条例。
These Regulations are formulated to effectively protect and rationally utilize the human genetic resources of China, and to safeguard public health, national security, and social public interests.
本条例所称人类遗传资源包括人类遗传资源材料和人类遗传资源信息。
For the purposes of these Regulations, human genetic resources include human genetic resource materials and human genetic resource information.
人类遗传资源材料是指含有人体基因组、基因等遗传物质的器官、组织、细胞等遗传材料。
Human genetic resource materials refer to genetic materials such as organs, tissues, and cells containing the human genome, genes, and other genetic substances.
人类遗传资源信息是指利用人类遗传资源材料产生的数据等信息资料。
Human genetic resource information refers to data and other information materials generated from the use of human genetic resource materials.
采集、保藏、利用、对外提供我国人类遗传资源，应当遵守本条例。
The collection, preservation, utilization, and external provision of human genetic resources of China shall comply with these Regulations.
为临床诊疗、采供血服务、查处违法犯罪、兴奋剂检测和殡葬等活动需要，采集、保藏器官、组织、细胞等人体物质及开展相关活动，依照相关法律、行政法规规定执行。
For activities such as clinical diagnosis and treatment, blood collection and supply services, investigation of illegal and criminal activities, doping testing, and funeral services, the collection and preservation of human substances such as organs, tissues, and cells, and related activities shall be carried out in accordance with relevant laws and administrative regulations.
国务院卫生健康主管部门负责全国人类遗传资源管理工作；国务院其他有关部门在各自的职责范围内，负责有关人类遗传资源管理工作。
The competent health department of the State Council shall be responsible for the management of human genetic resources nationwide; other relevant departments of the State Council shall be responsible for the management of human genetic resources within their respective scopes of duties.
省、自治区、直辖市人民政府人类遗传资源主管部门负责本行政区域人类遗传资源管理工作；省、自治区、直辖市人民政府其他有关部门在各自的职责范围内，负责本行政区域有关人类遗传资源管理工作。
The competent departments for human genetic resources of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the management of human genetic resources within their respective administrative regions; other relevant departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the management of human genetic resources within their respective administrative regions and within their respective scopes of duties.
国家加强对我国人类遗传资源的保护，开展人类遗传资源调查，对重要遗传家系和特定地区人类遗传资源实行申报登记制度。
The State strengthens the protection of human genetic resources of China, conducts surveys of human genetic resources, and implements a registration system for important genetic pedigrees and human genetic resources in specific regions.
国务院卫生健康主管部门负责组织我国人类遗传资源调查，制定重要遗传家系和特定地区人类遗传资源申报登记具体办法。
The health administrative department of the State Council is responsible for organizing surveys of human genetic resources of China and formulating specific measures for the registration of important genetic pedigrees and human genetic resources in specific regions.
国家支持合理利用人类遗传资源开展科学研究、发展生物医药产业、提高诊疗技术，提高我国生物安全保障能力，提升人民健康保障水平。
The State supports the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnostic and therapeutic technologies, enhance the national biosecurity capability, and improve the level of people's health protection.
外国组织、个人及其设立或者实际控制的机构不得在我国境内采集、保藏我国人类遗传资源，不得向境外提供我国人类遗传资源。
Foreign organizations, individuals, and institutions established or effectively controlled by them shall not collect or preserve human genetic resources of China within the territory of China, nor provide human genetic resources of China abroad.
采集、保藏、利用、对外提供我国人类遗传资源，不得危害我国公众健康、国家安全和社会公共利益。
The collection, preservation, utilization, and provision abroad of human genetic resources of China shall not harm public health, national security, or social public interests of China.
采集、保藏、利用、对外提供我国人类遗传资源，应当符合伦理原则，并按照国家有关规定进行伦理审查。
The collection, preservation, utilization, and provision abroad of human genetic resources of China shall comply with ethical principles and undergo ethical review in accordance with relevant state regulations.
采集、保藏、利用、对外提供我国人类遗传资源，应当尊重人类遗传资源提供者的隐私权，取得其事先知情同意，并保护其合法权益。
The collection, preservation, utilization, and provision abroad of human genetic resources of China shall respect the privacy rights of the providers of human genetic resources, obtain their prior informed consent, and protect their legitimate rights and interests.
采集、保藏、利用、对外提供我国人类遗传资源，应当遵守国务院卫生健康主管部门制定的技术规范。
The collection, preservation, utilization, and provision abroad of human genetic resources of China shall comply with the technical specifications formulated by the health administrative department of the State Council.
禁止买卖人类遗传资源。
The sale of human genetic resources is prohibited.
为科学研究依法提供或者使用人类遗传资源并支付或者收取合理成本费用，不视为买卖。
Providing or using human genetic resources in accordance with the law for scientific research and paying or receiving reasonable cost expenses shall not be deemed as sale.
采集和保藏
Collection and Preservation
采集我国重要遗传家系、特定地区人类遗传资源或者采集国务院卫生健康主管部门规定种类、数量的人类遗传资源的，应当符合下列条件，并经国务院卫生健康主管部门批准：
The collection of important genetic pedigrees, human genetic resources from specific regions, or human genetic resources of types and quantities specified by the health authority of the State Council shall meet the following conditions and be approved by the health authority of the State Council:
(一)具有法人资格；
(1) Having legal personality;
(二)采集目的明确、合法；
(2) The collection purpose is clear and lawful;
(三)采集方案合理；
(3) The collection plan is reasonable;
(四)通过伦理审查；
(4) Having passed ethical review;
(五)具有负责人类遗传资源管理的部门和管理制度；
(5) Having a department responsible for human genetic resources management and a management system;
(六)具有与采集活动相适应的场所、设施、设备和人员。
(6) Having premises, facilities, equipment, and personnel suitable for the collection activity.
采集我国人类遗传资源，应当事先告知人类遗传资源提供者采集目的、采集用途、对健康可能产生的影响、个人隐私保护措施及其享有的自愿参与和随时无条件退出的权利，征得人类遗传资源提供者书面同意。
When collecting human genetic resources in China, the collector shall inform the provider of the collection purpose, intended use, potential health impacts, personal privacy protection measures, and the right to voluntarily participate and withdraw at any time without conditions, and obtain the provider's written consent.
在告知人类遗传资源提供者前款规定的信息时，必须全面、完整、真实、准确，不得隐瞒、误导、欺骗。
When informing the provider of the information specified in the preceding paragraph, the information must be comprehensive, complete, truthful, and accurate, and shall not be concealed, misleading, or deceptive.
国家加强人类遗传资源保藏工作，加快标准化、规范化的人类遗传资源保藏基础平台和人类遗传资源大数据建设，为开展相关研究开发活动提供支撑。
The state strengthens the preservation of human genetic resources, accelerates the construction of standardized and normalized basic platforms for human genetic resource preservation and big data on human genetic resources, and provides support for carrying out relevant research and development activities.
国家鼓励科研机构、高等学校、医疗机构、企业根据自身条件和相关研究开发活动需要开展人类遗传资源保藏工作，并为其他单位开展相关研究开发活动提供便利。
The state encourages scientific research institutions, institutions of higher education, medical institutions, and enterprises to carry out preservation of human genetic resources according to their own conditions and needs of relevant research and development activities, and to provide convenience for other units to carry out relevant research and development activities.
保藏我国人类遗传资源、为科学研究提供基础平台的，应当符合下列条件，并经国务院卫生健康主管部门批准：
Preserving human genetic resources of China and providing basic platforms for scientific research shall meet the following conditions and be approved by the health administrative department of the State Council:
(一)具有法人资格；
(1) Having legal personality;
(二)保藏目的明确、合法；
(2) The preservation purpose is clear and lawful;
(三)保藏方案合理；
(3) The preservation plan is reasonable;
(四)拟保藏的人类遗传资源来源合法；
(4) The source of human genetic resources to be preserved is lawful;
(五)通过伦理审查；
(5) Having passed ethical review;
(六)具有负责人类遗传资源管理的部门和保藏管理制度；
(6) Having a department responsible for human genetic resource management and a preservation management system;
(七)具有符合国家人类遗传资源保藏技术规范和要求的场所、设施、设备和人员。
(7) Having premises, facilities, equipment, and personnel that meet the national technical specifications and requirements for human genetic resource preservation.
保藏单位应当对所保藏的人类遗传资源加强管理和监测，采取安全措施，制定应急预案，确保保藏、使用安全。
Preservation units shall strengthen the management and monitoring of the human genetic resources they preserve, adopt safety measures, formulate emergency plans, and ensure the safety of preservation and use.
保藏单位应当完整记录人类遗传资源保藏情况，妥善保存人类遗传资源的来源信息和使用信息，确保人类遗传资源的合法使用。
Preservation units shall fully record the preservation status of human genetic resources, properly maintain the source information and usage information of human genetic resources, and ensure the lawful use of human genetic resources.
保藏单位应当就本单位保藏人类遗传资源情况向国务院卫生健康主管部门提交年度报告。
Preservation units shall submit an annual report to the health administrative department of the State Council on the preservation of human genetic resources by their unit.
国家人类遗传资源保藏基础平台和数据库应当依照国家有关规定向有关科研机构、高等学校、医疗机构、企业开放。
The national basic platform and database for human genetic resources preservation shall be open to relevant scientific research institutions, institutions of higher education, medical institutions, and enterprises in accordance with relevant state regulations.
为公众健康、国家安全和社会公共利益需要，国家可以依法使用保藏单位保藏的人类遗传资源。
For the needs of public health, national security, and social public interests, the state may lawfully use human genetic resources preserved by preservation units.
利用和对外提供
Utilization and Provision to Foreign Parties
国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门应当会同本级人民政府有关部门对利用人类遗传资源开展科学研究、发展生物医药产业统筹规划，合理布局，加强创新体系建设，促进生物科技和产业创新、协调发展。
The health administrative department of the State Council and the competent departments for human genetic resources of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, together with the relevant departments of the people's governments at the same level, make overall planning and rational layout for the use of human genetic resources in scientific research and the development of the biomedical industry, strengthen the construction of innovation systems, and promote the innovation and coordinated development of biotechnology and industry.
科研机构、高等学校、医疗机构、企业利用人类遗传资源开展研究开发活动，对其研究开发活动以及成果的产业化依照法律、行政法规和国家有关规定予以支持。
Scientific research institutions, institutions of higher education, medical institutions, and enterprises that use human genetic resources to carry out research and development activities shall be supported in their research and development activities and the industrialization of their results in accordance with laws, administrative regulations, and relevant state provisions.
国家鼓励科研机构、高等学校、医疗机构、企业根据自身条件和相关研究开发活动需要，利用我国人类遗传资源开展国际合作科学研究，提升相关研究开发能力和水平。
The state encourages scientific research institutions, institutions of higher education, medical institutions, and enterprises to carry out international cooperative scientific research using China's human genetic resources based on their own conditions and the needs of relevant research and development activities, so as to enhance relevant research and development capabilities and levels.
利用我国人类遗传资源开展生物技术研究开发活动或者开展临床试验的，应当遵守有关生物技术研究、临床应用管理法律、行政法规和国家有关规定。
Those who use China's human genetic resources to carry out biotechnology research and development activities or conduct clinical trials shall comply with the laws, administrative regulations, and relevant state provisions on the management of biotechnology research and clinical application.
外国组织及外国组织、个人设立或者实际控制的机构(以下称外方单位)需要利用我国人类遗传资源开展科学研究活动的，应当遵守我国法律、行政法规和国家有关规定，并采取与我国科研机构、高等学校、医疗机构、企业(以下称中方单位)合作的方式进行。
Foreign organizations, and institutions established or actually controlled by foreign organizations or individuals (hereinafter referred to as foreign entities) that need to use Chinese human genetic resources for scientific research activities shall comply with Chinese laws, administrative regulations, and relevant state provisions, and shall conduct such activities in cooperation with Chinese scientific research institutions, higher education institutions, medical institutions, and enterprises (hereinafter referred to as Chinese entities).
利用我国人类遗传资源开展国际合作科学研究的，应当符合下列条件，并由合作双方共同提出申请，经国务院卫生健康主管部门批准：
International cooperative scientific research using Chinese human genetic resources shall meet the following conditions, and a joint application shall be submitted by both cooperating parties for approval by the health administrative department of the State Council:
(一)对我国公众健康、国家安全和社会公共利益没有危害；
(1) It does not harm public health, national security, or public interests;
(二)合作双方为具有法人资格的中方单位、外方单位，并具有开展相关工作的基础和能力；
(2) Both cooperating parties are Chinese entities and foreign entities with legal personality, and have the foundation and capability to carry out the relevant work;
(三)合作研究目的和内容明确、合法，期限合理；
(3) The purpose and content of the cooperative research are clear and lawful, and the duration is reasonable;
(四)合作研究方案合理；
(4) The cooperative research plan is reasonable;
(五)拟使用的人类遗传资源来源合法，种类、数量与研究内容相符；
(5) The human genetic resources to be used are from lawful sources, and their types and quantities match the research content;
(六)通过合作双方各自所在国(地区)的伦理审查；
(6) Ethical review has been passed in the respective countries (regions) of both cooperating parties;
(七)研究成果归属明确，有合理明确的利益分配方案。
(7) The ownership of research results is clear, and there is a reasonable and clear benefit-sharing plan.
为获得相关药品和医疗器械在我国上市许可，在临床机构利用我国人类遗传资源开展国际合作临床试验、不涉及人类遗传资源材料出境的，不需要审批。但是，合作双方在开展临床试验前应当将拟使用的人类遗传资源种类、数量及其用途向国务院卫生健康主管部门备案。国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门加强对备案事项的监管。
For international cooperative clinical trials conducted in clinical institutions using Chinese human genetic resources to obtain marketing approval for related drugs and medical devices in China, where no export of human genetic resource materials is involved, approval is not required. However, before conducting the clinical trial, both cooperating parties shall file the types, quantities, and intended uses of the human genetic resources to be used with the health administrative department of the State Council. The health administrative department of the State Council and the human genetic resource administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen supervision over the filed matters.
在利用我国人类遗传资源开展国际合作科学研究过程中，合作方、研究目的、研究内容、合作期限等重大事项发生变更的，应当办理变更审批手续。
In the process of conducting international collaborative scientific research using China's human genetic resources, if major matters such as the collaborator, research purpose, research content, or cooperation period change, an approval procedure for the change shall be undertaken.
利用我国人类遗传资源开展国际合作科学研究，应当保证中方单位及其研究人员在合作期间全过程、实质性地参与研究，研究过程中的所有记录以及数据信息等完全向中方单位开放并向中方单位提供备份。
When conducting international collaborative scientific research using China's human genetic resources, it shall be ensured that the Chinese entity and its researchers participate fully and substantively throughout the entire cooperation period, and all records and data information during the research process shall be fully open to the Chinese entity and backups shall be provided to the Chinese entity.
利用我国人类遗传资源开展国际合作科学研究，产生的成果申请专利的，应当由合作双方共同提出申请，专利权归合作双方共有。研究产生的其他科技成果，其使用权、转让权和利益分享办法由合作双方通过合作协议约定；协议没有约定的，合作双方都有使用的权利，但向第三方转让须经合作双方同意，所获利益按合作双方贡献大小分享。
When conducting international collaborative scientific research using China's human genetic resources, if a patent application is filed for the results generated, it shall be jointly filed by both cooperating parties, and the patent rights shall be jointly owned by both parties. For other scientific and technological achievements generated from the research, the rights of use, transfer rights, and benefit-sharing methods shall be agreed upon by both cooperating parties through a cooperation agreement; if the agreement does not specify, both parties have the right to use, but transfer to a third party requires the consent of both parties, and the benefits obtained shall be shared according to the contribution of each party.
利用我国人类遗传资源开展国际合作科学研究，合作双方应当按照平等互利、诚实信用、共同参与、共享成果的原则，依法签订合作协议，并依照本条例第二十四条的规定对相关事项作出明确、具体的约定。
When conducting international collaborative scientific research using China's human genetic resources, both cooperating parties shall sign a cooperation agreement in accordance with the principles of equality and mutual benefit, good faith, joint participation, and shared results, and shall make clear and specific stipulations on relevant matters in accordance with the provisions of Article 24 of these Regulations.
利用我国人类遗传资源开展国际合作科学研究，合作双方应当在国际合作活动结束后6个月内共同向国务院卫生健康主管部门提交合作研究情况报告。
When conducting international collaborative scientific research using China's human genetic resources, both cooperating parties shall jointly submit a report on the collaborative research to the health administrative department of the State Council within six months after the conclusion of the international collaborative activity.
利用我国人类遗传资源开展国际合作科学研究，或者因其他特殊情况确需将我国人类遗传资源材料运送、邮寄、携带出境的，应当符合下列条件，并取得国务院卫生健康主管部门出具的人类遗传资源材料出境证明：
When conducting international collaborative scientific research using China's human genetic resources, or if it is truly necessary to transport, mail, or carry human genetic resource materials out of China due to other special circumstances, the following conditions shall be met, and a certificate for the export of human genetic resource materials issued by the health administrative department of the State Council shall be obtained:
(一)对我国公众健康、国家安全和社会公共利益没有危害；
(1) It does not harm public health, national security, or social public interests of China;
(二)具有法人资格；
(2) The entity has legal personality;
(三)有明确的境外合作方和合理的出境用途；
(3) There is a clear foreign collaborator and a reasonable purpose for export;
(四)人类遗传资源材料采集合法或者来自合法的保藏单位；
(4) The collection of human genetic resource materials is lawful or comes from a lawful preservation unit.
(五)通过伦理审查。
(5) Pass ethical review.
利用我国人类遗传资源开展国际合作科学研究，需要将我国人类遗传资源材料运送、邮寄、携带出境的，可以单独提出申请，也可以在开展国际合作科学研究申请中列明出境计划一并提出申请，由国务院卫生健康主管部门合并审批。
When conducting international collaborative scientific research using China's human genetic resources, if it is necessary to transport, mail, or carry human genetic resource materials out of China, an application may be submitted separately, or the exit plan may be included in the application for international collaborative scientific research and submitted together, with the health administrative department of the State Council conducting a consolidated review.
将我国人类遗传资源材料运送、邮寄、携带出境的，凭人类遗传资源材料出境证明办理海关手续。
To transport, mail, or carry China's human genetic resource materials out of China, customs procedures shall be handled with the human genetic resource materials exit certificate.
将人类遗传资源信息向外国组织、个人及其设立或者实际控制的机构提供或者开放使用，不得危害我国公众健康、国家安全和社会公共利益；可能影响我国公众健康、国家安全和社会公共利益的，应当通过国务院卫生健康主管部门组织的安全审查。
Providing or making open use of human genetic resource information to foreign organizations, individuals, or entities established or actually controlled by them shall not harm the public health, national security, or social public interests of China; if it may affect the public health, national security, or social public interests of China, it shall pass a security review organized by the health administrative department of the State Council.
将人类遗传资源信息向外国组织、个人及其设立或者实际控制的机构提供或者开放使用的，应当向国务院卫生健康主管部门备案并提交信息备份。
Providing or making open use of human genetic resource information to foreign organizations, individuals, or entities established or actually controlled by them shall be filed with the health administrative department of the State Council and a copy of the information shall be submitted.
利用我国人类遗传资源开展国际合作科学研究产生的人类遗传资源信息，合作双方可以使用。
Human genetic resource information generated from international collaborative scientific research using China's human genetic resources may be used by both parties to the collaboration.
服务和监督
Services and Supervision
国务院卫生健康主管部门应当加强电子政务建设，方便申请人利用互联网办理审批、备案等事项。
The health administrative department of the State Council shall strengthen e-government construction to facilitate applicants in handling matters such as approval and filing via the internet.
国务院卫生健康主管部门应当制定并及时发布有关采集、保藏、利用、对外提供我国人类遗传资源的审批指南和示范文本，加强对申请人办理有关审批、备案等事项的指导。
The health administrative department of the State Council shall formulate and promptly publish guidelines and model documents for approval related to the collection, preservation, utilization, and provision of China's human genetic resources to foreign parties, and strengthen guidance for applicants in handling matters such as approval and filing.
国务院卫生健康主管部门应当聘请生物技术、医药、卫生、伦理、法律等方面的专家组成专家评审委员会，对依照本条例规定提出的采集、保藏我国人类遗传资源，开展国际合作科学研究以及将我国人类遗传资源材料运送、邮寄、携带出境的申请进行技术评审。评审意见作为作出审批决定的参考依据。
The health administrative department of the State Council shall engage experts in biotechnology, medicine, health, ethics, law, and other fields to form an expert review committee to conduct technical reviews of applications submitted in accordance with these regulations for the collection and preservation of China's human genetic resources, international collaborative scientific research, and the transport, mailing, or carrying of human genetic resource materials out of China. The review opinions shall serve as a reference basis for making approval decisions.
国务院卫生健康主管部门应当自受理依照本条例规定提出的采集、保藏我国人类遗传资源，开展国际合作科学研究以及将我国人类遗传资源材料运送、邮寄、携带出境申请之日起20个工作日内，作出批准或者不予批准的决定；不予批准的，应当说明理由。因特殊原因无法在规定期限内作出审批决定的，经国务院卫生健康主管部门负责人批准，可以延长10个工作日。
The health administrative department of the State Council shall, within 20 working days from the date of accepting an application submitted in accordance with these Regulations for the collection, preservation of human genetic resources of China, conducting international cooperative scientific research, and transporting, mailing, or carrying human genetic resource materials out of China, make a decision to approve or disapprove; if disapproved, reasons shall be stated. If it is impossible to make a decision within the prescribed time limit due to special reasons, the time limit may be extended by 10 working days with the approval of the person in charge of the health administrative department of the State Council.
国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门应当加强对采集、保藏、利用、对外提供人类遗传资源活动各环节的监督检查，发现违反本条例规定的，及时依法予以处理并向社会公布检查、处理结果。
The health administrative department of the State Council and the human genetic resources administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen supervision and inspection over all aspects of the collection, preservation, utilization, and provision abroad of human genetic resources. If any violation of these Regulations is found, it shall be dealt with in a timely manner according to law, and the inspection and handling results shall be made public.
国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门进行监督检查，可以采取下列措施：
The health administrative department of the State Council and the human genetic resources administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may take the following measures when conducting supervision and inspection:
(一)进入现场检查；
(1) Entering the site for inspection;
(二)询问相关人员；
(2) Inquiring relevant personnel;
(三)查阅、复制有关资料；
(3) Reviewing and copying relevant materials;
(四)查封、扣押有关人类遗传资源。
(4) Sealing and seizing relevant human genetic resources.
任何单位和个人对违反本条例规定的行为，有权向国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门投诉、举报。
Any unit or individual has the right to complain or report to the health administrative department of the State Council and the human genetic resources administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government about any act violating these Regulations.
国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门应当公布投诉、举报电话和电子邮件地址，接受相关投诉、举报。对查证属实的，给予举报人奖励。
The health administrative department of the State Council and the human genetic resources administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall publish complaint and report telephone numbers and email addresses to accept relevant complaints and reports. Rewards shall be given to whistleblowers whose reports are verified.
法 律 责 任
Legal Liability
违反本条例规定，有下列情形之一的，由国务院卫生健康主管部门责令停止违法行为，没收违法采集、保藏的人类遗传资源和违法所得，处50万元以上500万元以下罚款，违法所得在100万元以上的，处违法所得5倍以上10倍以下罚款：
In violation of these regulations, under any of the following circumstances, the health administrative department of the State Council shall order cessation of the illegal act, confiscate the illegally collected or preserved human genetic resources and illegal gains, impose a fine of not less than 500,000 yuan but not more than 5 million yuan, and if the illegal gains exceed 1 million yuan, impose a fine of not less than 5 times but not more than 10 times the illegal gains:
(一)未经批准，采集我国重要遗传家系、特定地区人类遗传资源，或者采集国务院卫生健康主管部门规定种类、数量的人类遗传资源；
(1) Collecting important genetic pedigrees of our country, human genetic resources from specific regions, or human genetic resources of types or quantities specified by the health administrative department of the State Council without approval;
(二)未经批准，保藏我国人类遗传资源；
(2) Preserving human genetic resources of our country without approval;
(三)未经批准，利用我国人类遗传资源开展国际合作科学研究；
(3) Conducting international cooperative scientific research using human genetic resources of our country without approval;
(四)未通过安全审查，将可能影响我国公众健康、国家安全和社会公共利益的人类遗传资源信息向外国组织、个人及其设立或者实际控制的机构提供或者开放使用；
(4) Providing or making available for use information on human genetic resources that may affect public health, national security, or public interests of our country to foreign organizations, individuals, or institutions established or actually controlled by them without passing a security review;
(五)开展国际合作临床试验前未将拟使用的人类遗传资源种类、数量及其用途向国务院卫生健康主管部门备案。
(5) Failing to file with the health administrative department of the State Council the types, quantities, and purposes of human genetic resources to be used before conducting international cooperative clinical trials.
提供虚假材料或者采取其他欺骗手段取得行政许可的，由国务院卫生健康主管部门撤销已经取得的行政许可，处50万元以上500万元以下罚款，5年内不受理相关责任人及单位提出的许可申请。
If a person obtains an administrative license by providing false materials or other fraudulent means, the health administrative department of the State Council shall revoke the obtained administrative license, impose a fine of not less than 500,000 yuan but not more than 5 million yuan, and shall not accept license applications from the relevant responsible persons and units within 5 years.
违反本条例规定，未经批准将我国人类遗传资源材料运送、邮寄、携带出境的，由海关依照法律、行政法规的规定处罚。人类遗传资源主管部门应当配合海关开展鉴定等执法协助工作。海关应当将依法没收的人类遗传资源材料移送省、自治区、直辖市人民政府人类遗传资源主管部门进行处理。
In violation of these regulations, if human genetic resource materials of our country are transported, mailed, or carried out of the country without approval, the customs shall impose penalties in accordance with laws and administrative regulations. The human genetic resource administrative department shall cooperate with the customs in conducting identification and other law enforcement assistance. The customs shall transfer the confiscated human genetic resource materials to the human genetic resource administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government for handling.
违反本条例规定，有下列情形之一的，由省、自治区、直辖市人民政府人类遗传资源主管部门责令停止开展相关活动，没收违法采集、保藏的人类遗传资源和违法所得，处50万元以上100万元以下罚款，违法所得在100万元以上的，处违法所得5倍以上10倍以下罚款：
In violation of these regulations, under any of the following circumstances, the human genetic resource administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order cessation of the relevant activities, confiscate the illegally collected or preserved human genetic resources and illegal gains, impose a fine of not less than 500,000 yuan but not more than 1 million yuan, and if the illegal gains exceed 1 million yuan, impose a fine of not less than 5 times but not more than 10 times the illegal gains:
(一)采集、保藏、利用、对外提供我国人类遗传资源未通过伦理审查；
(1) Collecting, preserving, using, or providing human genetic resources of our country to foreign parties without passing ethical review.
(二)采集我国人类遗传资源未经人类遗传资源提供者事先知情同意，或者采取隐瞒、误导、欺骗等手段取得人类遗传资源提供者同意；
(2) Collecting human genetic resources of China without prior informed consent from the provider, or obtaining consent through concealment, misrepresentation, or deception;
(三)采集、保藏、利用、对外提供我国人类遗传资源违反相关技术规范；
(3) Collecting, preserving, utilizing, or providing abroad human genetic resources of China in violation of relevant technical specifications;
(四)将人类遗传资源信息向外国组织、个人及其设立或者实际控制的机构提供或者开放使用，未向国务院卫生健康主管部门备案或者提交信息备份。
(4) Providing or making open use of human genetic resource information to foreign organizations, individuals, or institutions established or actually controlled by them, without filing with the health department of the State Council or submitting a backup of the information.
违反本条例规定，有下列情形之一的，由国务院卫生健康主管部门责令改正，给予警告，可以处50万元以下罚款：
In violation of these regulations, under any of the following circumstances, the health department of the State Council shall order correction, give a warning, and may impose a fine of up to 500,000 yuan:
(一)保藏我国人类遗传资源过程中未完整记录并妥善保存人类遗传资源的来源信息和使用信息；
(1) Failing to completely record and properly preserve the source information and usage information of human genetic resources during the preservation process;
(二)保藏我国人类遗传资源未提交年度报告；
(2) Failing to submit an annual report on the preservation of human genetic resources;
(三)开展国际合作科学研究未及时提交合作研究情况报告。
(3) Failing to submit a timely report on the progress of international cooperative scientific research.
外国组织、个人及其设立或者实际控制的机构违反本条例规定，在我国境内采集、保藏我国人类遗传资源，利用我国人类遗传资源开展科学研究，或者向境外提供我国人类遗传资源的，由国务院卫生健康主管部门责令停止违法行为，没收违法采集、保藏的人类遗传资源和违法所得，处100万元以上1000万元以下罚款，违法所得在100万元以上的，处违法所得5倍以上10倍以下罚款。
If a foreign organization, individual, or institution established or actually controlled by them violates these regulations by collecting or preserving human genetic resources of China within China, conducting scientific research using such resources, or providing them abroad, the health department of the State Council shall order cessation of the illegal act, confiscate the illegally collected or preserved human genetic resources and illegal gains, and impose a fine of between 1 million and 10 million yuan; if the illegal gains exceed 1 million yuan, a fine of between 5 and 10 times the illegal gains shall be imposed.
违反本条例规定，买卖人类遗传资源的，由国务院卫生健康主管部门责令停止违法行为，没收违法采集、保藏的人类遗传资源和违法所得，处100万元以上1000万元以下罚款，违法所得在100万元以上的，处违法所得5倍以上10倍以下罚款。
In violation of these regulations, if human genetic resources are traded, the health department of the State Council shall order cessation of the illegal act, confiscate the illegally collected or preserved human genetic resources and illegal gains, and impose a fine of between 1 million and 10 million yuan; if the illegal gains exceed 1 million yuan, a fine of between 5 and 10 times the illegal gains shall be imposed.
对有本条例第三十六条、第三十九条、第四十一条、第四十二条规定违法行为的单位，情节严重的，由国务院卫生健康主管部门或者省、自治区、直辖市人民政府人类遗传资源主管部门依据职责禁止其1至5年内从事采集、保藏、利用、对外提供我国人类遗传资源的活动；情节特别严重的，永久禁止其从事采集、保藏、利用、对外提供我国人类遗传资源的活动。
For entities that commit illegal acts under Articles 36, 39, 41, and 42 of these regulations, if the circumstances are serious, the health department of the State Council or the provincial-level human genetic resources department shall, according to their authority, prohibit them from engaging in the collection, preservation, utilization, and provision abroad of human genetic resources of China for a period of 1 to 5 years; if the circumstances are especially serious, they shall be permanently prohibited from engaging in such activities.
对有本条例第三十六条至第三十九条、第四十一条、第四十二条规定违法行为的单位的法定代表人、主要负责人、直接负责的主管人员以及其他责任人员，依法给予处分，并由国务院卫生健康主管部门或者省、自治区、直辖市人民政府人类遗传资源主管部门依据职责没收其违法所得，处50万元以下罚款；情节严重的，禁止其1至5年内从事采集、保藏、利用、对外提供我国人类遗传资源的活动；情节特别严重的，永久禁止其从事采集、保藏、利用、对外提供我国人类遗传资源的活动。
For the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of a unit that commits illegal acts under Articles 36 to 39, 41, and 42 of these Regulations, disciplinary action shall be taken in accordance with the law, and the health administrative department of the State Council or the human genetic resources administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, based on their duties, confiscate the illegal gains and impose a fine of not more than 500,000 yuan; if the circumstances are serious, they shall be prohibited from engaging in the collection, preservation, utilization, and provision of human genetic resources to foreign parties for a period of 1 to 5 years; if the circumstances are especially serious, they shall be permanently prohibited from engaging in the collection, preservation, utilization, and provision of human genetic resources to foreign parties.
单位和个人有本条例规定违法行为的，记入信用记录，并依照有关法律、行政法规的规定向社会公示。
If a unit or individual commits an illegal act under these Regulations, it shall be recorded in the credit record and publicly disclosed in accordance with relevant laws and administrative regulations.
违反本条例规定，侵害他人合法权益的，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 infringes upon the lawful rights and interests of others shall bear civil liability in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
国务院卫生健康主管部门和省、自治区、直辖市人民政府人类遗传资源主管部门的工作人员违反本条例规定，不履行职责或者滥用职权、玩忽职守、徇私舞弊的，依法给予处分；构成犯罪的，依法追究刑事责任。
Staff members of the health administrative department of the State Council and the human genetic resources administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government who violate these Regulations by failing to perform their duties, abusing their power, neglecting their duties, or engaging in malpractice for personal gain shall be given disciplinary action in accordance with the law; if a crime is constituted, criminal liability shall be pursued in accordance with the law.
附 则
Supplementary Provisions
人类遗传资源相关信息属于国家秘密的，应当依照《中华人民共和国保守国家秘密法》和国家其他有关保密规定实施保密管理。
If information related to human genetic resources constitutes a state secret, confidentiality management shall be implemented in accordance with the Law of the People's Republic of China on Guarding State Secrets and other relevant state confidentiality provisions.
本条例自2019年7月1日起施行。
These Regulations shall come into force on July 1, 2019.