[CLI Code]: CLI.2.

333002(EN)

Regulation of the People's Republic of China on the Administration of Human Genetic

Resources
中华人民共和国人类遗传资源管理条例

Document Number : Order No. 717 of the State Council of the People's Republic of China
Area of Law : General Provisions on Health and Sanitation
Level of Authority : Administrative Regulations
Date issued : 05-28-2019
Effective Date : 07-01-2019
Issuing Authority : State Council
Status : Effective

Order of the State Council of the People's Republic of China 中华人民共和国国务院令

(No. 717) （第 717 号）

The Regulation of the People's Republic of China on the Administration of Human 《中华人民共和国人类遗传资源管理
Genetic Resources, as adopted at the 41st executive meeting of the State Council on 条例》已经 2019 年 3 月 20 日国务院
March 20, 2019, is hereby issued, and shall come into force on July 1, 2019. 第 41 次常务会议通过，现予公布，自
2019 年 7 月 1 日起施行。

Premier: Li Keqiang 总理 李克强

May 28, 2019 2019 年 5 月 28 日

Regulation of the People's Republic of China on the Administration of Human Genetic 中华人民共和国人类遗传资源管理条
Resources 例

Chapter I General Provisions 第一章 总 则

Article 1 This Regulation is developed for the purposes of effectively protecting and 第一条 为了有效保护和合理利用我
rationally using China's human genetic resources, and safeguarding public health, 国人类遗传资源，维护公众健康、国
national security and public interest. 家安全和社会公共利益，制定本条例。

Article 2 For the purposes of this Regulation, the term “human genetic resources” 第二条 本条例所称人类遗传资源包
includes the materials of human genetic resources and information on human genetic 括人类遗传资源材料和人类遗传资源
resources. 信息。

The term “materials of human genetic resources” means genetic materials such as 人类遗传资源材料是指含有人体基因
organs, tissues and cells which contain human genomes, genes and other genetic 组、基因等遗传物质的器官、组织、
substances. 细胞等遗传材料。

The term “information on human genetic resources” means information materials such 人类遗传资源信息是指利用人类遗传
as data generated from the utilization of materials of human genetic resources. 资源材料产生的数据等信息资料。

Article 3 The collection, preservation, utilization and external provision of China's 第三条 采集、保藏、利用、对外提
human genetic resources shall comply with this Regulation. 供我国人类遗传资源，应当遵守本条
例。

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The collection and preservation of organs, tissues, cells and other human substances 为临床诊疗、采供血服务、查处违法
and relevant activities conducted for such activities as clinical diagnosis and treatment, 犯罪、兴奋剂检测和殡葬等活动需要，
blood sampling and supply services, investigation and handling of violations and 采集、保藏器官、组织、细胞等人体
crimes, stimulant detection and funeral and interment shall be governed by the 物质及开展相关活动，依照相关法律、
provisions of relevant laws and administrative regulations. 行政法规规定执行。

Article 4 The science and technology administrative department of the State Council 第四条 国务院科学技术行政部门负
shall be responsible for the administration of human genetic resources throughout the 责全国人类遗传资源管理工作；国务
country. Other relevant departments of the State Council shall be responsible for the 院其他有关部门在各自的职责范围内，
administration of human genetic resources within the scope of their respective 负责有关人类遗传资源管理工作。
functions and powers.

The science and technology administrative departments of people's governments of 省、自治区、直辖市人民政府科学技

provinces, autonomous regions and municipalities directly under the Central 术行政部门负责本行政区域人类遗传
Government shall be responsible for the administration of human genetic resources 资源管理工作；省、自治区、直辖市
within their respective administrative regions; other relevant departments of people's 人民政府其他有关部门在各自的职责
governments of provinces, autonomous regions and municipalities directly under the 范围内，负责本行政区域有关人类遗
Central Government shall be responsible for the administration of human genetic 传资源管理工作。
resources within their respective administrative regions within the scope of their
respective functions and powers.

Article 5 The state shall strengthen the protection of China's human genetic resources, 第五条 国家加强对我国人类遗传资
conduct investigation on human genetic resources, and implement the declaration and 源的保护，开展人类遗传资源调查，
registration system for human genetic resources of important genetic families and 对重要遗传家系和特定地区人类遗传
specific regions. 资源实行申报登记制度。

The science and technology administrative department of the State Council shall be 国务院科学技术行政部门负责组织我
responsible for organizing the investigation of China's human genetic resources and 国人类遗传资源调查，制定重要遗传
formulating specific measures for the declaration and registration of human genetic 家系和特定地区人类遗传资源申报登
resources of important genetic families and specific regions. 记具体办法。

Article 6 The state supports the rational use of human genetic resources to carry out 第六条 国家支持合理利用人类遗传
scientific research, develop biomedical industry, improve diagnosis and treatment 资源开展科学研究、发展生物医药产
technologies, enhance China's biosafety guarantee capabilities, and raise the level of 业、提高诊疗技术，提高我国生物安
guaranteeing the people's health. 全保障能力，提升人民健康保障水平。

Article 7 Foreign organizations and individuals and the institutions formed or actually 第七条 外国组织、个人及其设立或
controlled by them shall not collect or preserve China's human genetic resources 者实际控制的机构不得在我国境内采
within the territory of China, and shall not provide China's human genetic resources 集、保藏我国人类遗传资源，不得向
abroad. 境外提供我国人类遗传资源。

Article 8 The collection, preservation, utilization and external provision of China's 第八条 采集、保藏、利用、对外提
human genetic resources shall not endanger China's public health, national security or 供我国人类遗传资源，不得危害我国
public interest. 公众健康、国家安全和社会公共利益。

Article 9 The collection, preservation, utilization and external provision of China's 第九条 采集、保藏、利用、对外提
human genetic resources shall conform to ethical principles and be subject to ethical 供我国人类遗传资源，应当符合伦理

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review in accordance with the relevant provisions of the state. 原则，并按照国家有关规定进行伦理

审查。

The collection, preservation, utilization and external provision of China's human 采集、保藏、利用、对外提供我国人
genetic resources shall respect the right of privacy of human genetic resource 类遗传资源，应当尊重人类遗传资源
providers, obtain their prior consent, and protect their lawful rights and interests. 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 external provision of China's human 采集、保藏、利用、对外提供我国人
genetic resources shall comply with technical specifications of the science and 类遗传资源，应当遵守国务院科学技
technology administrative department of the State Council. 术行政部门制定的技术规范。

Article 10 The trading in human genetic resources shall be prohibited. 第十条 禁止买卖人类遗传资源。

The legal provision or use of human genetic resources for scientific research and 为科学研究依法提供或者使用人类遗
payment or collection of reasonable cost and expenses shall not be deemed as trading. 传资源并支付或者收取合理成本费用，
不视为买卖。

Chapter II Collection and Preservation 第二章 采集和保藏

Article 11 The collection of China's human genetic resources of important genetic 第十一条 采集我国重要遗传家系、
families and specific regions, or the collection of human genetic resources of the types 特定地区人类遗传资源或者采集国务
and quantities prescribed by the science and technology administrative department of 院科学技术行政部门规定种类、数量
the State Council shall meet the following conditions and be subject to approval by the 的人类遗传资源的，应当符合下列条
science and technology administrative department of the State Council: 件，并经国务院科学技术行政部门批
准：

(1) Having the legal person status. （一）具有法人资格；

(2) Having specific and lawful purposes of collection. （二）采集目的明确、合法；

(3) Having reasonable collection plans. （三）采集方案合理；

(4) Having passed the ethical review. （四）通过伦理审查；

(5) Having the department responsible for the management of human genetic resources （五）具有负责人类遗传资源管理的
and management rules. 部门和管理制度；

(6) Having places, facilities, equipment and personnel that are compatible with （六）具有与采集活动相适应的场所、
collection activities. 设施、设备和人员。

Article 12 In the collection of China's human genetic resources, human genetic 第十二条 采集我国人类遗传资源，
resource providers shall be informed in advance of the collection purpose, use, 应当事先告知人类遗传资源提供者采
possible impact on health, personal privacy protection measures and their right to 集目的、采集用途、对健康可能产生
voluntary participate and withdraw unconditionally at any time, and the written 的影响、个人隐私保护措施及其享有
consent of human genetic resource providers shall be obtained. 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。

Human genetic resource providers shall be informed of the information prescribed in 在告知人类遗传资源提供者前款规定
the preceding paragraph in a comprehensive, complete, true and accurate manner, no 的信息时，必须全面、完整、真实、
information shall be concealed, and providers shall not be misled or deceived. 准确，不得隐瞒、误导、欺骗。

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Article 13 The state shall strengthen the preservation of human genetic resources, and 第十三条 国家加强人类遗传资源保
accelerate the construction of standardized and regulated basic platforms for the 藏工作，加快标准化、规范化的人类
preservation of human genetic resources and big data on human genetic resources, to 遗传资源保藏基础平台和人类遗传资
provide support for relevant research and development activities. 源大数据建设，为开展相关研究开发
活动提供支撑。

The state encourages scientific research institutions, institutions of higher learning, 国家鼓励科研机构、高等学校、医疗
medical institutions and enterprises to preserve human genetic resources according to 机构、企业根据自身条件和相关研究
their own conditions and as required for relevant research and development activities, 开发活动需要开展人类遗传资源保藏
and to facilitate relevant research and development activities conducted by other 工作，并为其他单位开展相关研究开
entities. 发活动提供便利。

Article 14 The preservation of China's human genetic resources to provide a basic 第十四条 保藏我国人类遗传资源、
platform for scientific research shall meet the following conditions and be subject to 为科学研究提供基础平台的，应当符
approval by the science and technology administrative department of the State 合下列条件，并经国务院科学技术行
Council: 政部门批准：

(1) Having the legal person status. （一）具有法人资格；

(2) Having specific and lawful preservation purposes. （二）保藏目的明确、合法；

(3) Having reasonable preservation plans. （三）保藏方案合理；

(4) Having lawful source of human genetic resources to be preserved. （四）拟保藏的人类遗传资源来源合

法；

(5) Having passed the ethical review. （五）通过伦理审查；

(6) Having the department responsible for the management of human genetic resources （六）具有负责人类遗传资源管理的
and preservation management rules. 部门和保藏管理制度；

(7) Having places, facilities, equipment and personnel that comply with the national （七）具有符合国家人类遗传资源保
technical specifications and requirements for the preservation of human genetic 藏技术规范和要求的场所、设施、设
resources. 备和人员。

Article 15 The preservation entity shall strengthen the management and monitoring of 第十五条 保藏单位应当对所保藏的
the preserved human genetic resources, take security measures, and make emergency 人类遗传资源加强管理和监测，采取
response plans to ensure preservation and use safety. 安全措施，制定应急预案，确保保藏、
使用安全。

The preservation entity shall fully record the preservation of human genetic resources, 保藏单位应当完整记录人类遗传资源
properly preserve the information on the source and use of human genetic resources, 保藏情况，妥善保存人类遗传资源的
and ensure the legal use of human genetic resources. 来源信息和使用信息，确保人类遗传
资源的合法使用。

The preservation entity shall submit annual reports on the entity's preservation of 保藏单位应当就本单位保藏人类遗传
human genetic resources to the science and technology administrative department of 资源情况向国务院科学技术行政部门
the State Council. 提交年度报告。

Article 16 The national basic platform and database for the preservation of human 第十六条 国家人类遗传资源保藏基
genetic resources shall be open to relevant scientific research institutions, institutions 础平台和数据库应当依照国家有关规

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of higher learning, medical institutions and enterprises in accordance with the relevant 定向有关科研机构、高等学校、医疗
provisions of the state. 机构、企业开放。

As required for public health, national security and public interest, the state may use 为公众健康、国家安全和社会公共利
the human genetic resources preserved by the preservation entities in accordance with 益需要，国家可以依法使用保藏单位
the law. 保藏的人类遗传资源。

Chapter III Utilization and External Provision 第三章 利用和对外提供

Article 17 The science and technology administrative department of the State Council 第十七条 国务院科学技术行政部门
and science and technology administrative departments of people's governments of 和省、自治区、直辖市人民政府科学
provinces, autonomous regions and municipalities directly under the Central 技术行政部门应当会同本级人民政府
Government shall, in conjunction with relevant departments of people's governments 有关部门对利用人类遗传资源开展科
at the same level, make overall planning and rational layout on using human genetic 学研究、发展生物医药产业统筹规划，
resources to conduct scientific research and develop the biomedical industry, 合理布局，加强创新体系建设，促进
strengthen the construction of innovation systems, and promote the innovated and 生物科技和产业创新、协调发展。
coordinated development of biotechnology and industry.

Article 18 The research and development activities conducted by scientific research 第十八条 科研机构、高等学校、医
institutions, institutions of higher learning, medical institutions and enterprises by 疗机构、企业利用人类遗传资源开展
using human genetic resources and industrialization of results shall be supported in 研究开发活动，对其研究开发活动以
accordance with laws, administrative regulations and relevant provisions of the state. 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。

Article 19 The state encourages scientific research institutions, institutions of higher 第十九条 国家鼓励科研机构、高等
learning, medical institutions and enterprises to use China's human genetic resources to 学校、医疗机构、企业根据自身条件
conduct scientific research through international cooperation according to their own 和相关研究开发活动需要，利用我国
conditions and as required for relevant research and development activities, and 人类遗传资源开展国际合作科学研究，
enhance relevant research and development capabilities and levels. 提升相关研究开发能力和水平。

Article 20 Biotechnology research and development activities or clinical trials 第二十条 利用我国人类遗传资源开
conducted by using China's human genetic resources shall comply with the laws and 展生物技术研究开发活动或者开展临
administrative regulations on the administration of biotechnology research and clinical 床试验的，应当遵守有关生物技术研
application and relevant provisions of the state. 究、临床应用管理法律、行政法规和
国家有关规定。

Article 21 Where a foreign organization or an institution formed or actually controlled 第二十一条 外国组织及外国组织、
by a foreign organization or individual (hereinafter referred to as the “foreign entity”) 个人设立或者实际控制的机构（以下
needs to use China's human genetic resources to conduct scientific research activities, 称外方单位）需要利用我国人类遗传
it shall comply with China's laws, administrative regulations and relevant provisions of 资源开展科学研究活动的，应当遵守
the state, and cooperate with China's scientific research institutions, institutions of 我国法律、行政法规和国家有关规定，
higher learning, medical institutions and enterprises (hereinafter referred to as 并采取与我国科研机构、高等学校、
“Chinese entities”). 医疗机构、企业（以下称中方单位）
合作的方式进行。

Article 22 The scientific research conducted through international cooperation by 第二十二条 利用我国人类遗传资源
using China's human genetic resources shall meet the following conditions, and both 开展国际合作科学研究的，应当符合
parties to cooperation shall jointly file an application, which shall be subject to 下列条件，并由合作双方共同提出申
approval by the science and technology administrative department of the State 请，经国务院科学技术行政部门批准：

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Council:

(1) It causes no harm to China's public health, national security and public interest. （一）对我国公众健康、国家安全和
社会公共利益没有危害；

(2) The parties to cooperation are Chinese entities and foreign entities with legal （二）合作双方为具有法人资格的中
person status, and have the basis and ability to conduct the relevant work. 方单位、外方单位，并具有开展相关
工作的基础和能力；

(3) The purpose and content of cooperative research are specific and legal, and the （三）合作研究目的和内容明确、合
period of cooperative research is reasonable. 法，期限合理；

(4) The cooperative research plan is reasonable. （四）合作研究方案合理；

(5) The source of human genetic resources to be used is legal, and the type and （五）拟使用的人类遗传资源来源合
quantity are consistent with the research content. 法，种类、数量与研究内容相符；

(6) It has passed the ethical review of the country (region) where either party to （六）通过合作双方各自所在国（地
cooperation is located. 区）的伦理审查；

(7) The ownership of the research result is specific and there is a reasonable and （七）研究成果归属明确，有合理明
specific interest distribution plan. 确的利益分配方案。

In order to obtain the licensing for the listing of relevant drugs and medical devices in 为获得相关药品和医疗器械在我国上
China, the clinical trials conducted through international cooperation at clinical 市许可，在临床机构利用我国人类遗
institutions by using China's human genetic resources are not subject to approval 传资源开展国际合作临床试验、不涉
provided that they do not involve the transport of materials of human genetic resources 及人类遗传资源材料出境的，不需要
out of China. However, the type, quantity and use of human genetic resources to be 审批。但是，合作双方在开展临床试
used shall, before both parties to cooperation conduct clinical trials, be submitted to 验前应当将拟使用的人类遗传资源种
the science and technology administrative department of the State Council for 类、数量及其用途向国务院科学技术
recordation. The science and technology administrative department of the State 行政部门备案。国务院科学技术行政
Council and science and technology administrative departments of people's 部门和省、自治区、直辖市人民政府
governments of provinces, autonomous regions and municipalities directly under the 科学技术行政部门加强对备案事项的
Central Government shall strengthen the supervision of recordation matters. 监管。

Article 23 In the case of modification to the cooperation partner, research objective, 第二十三条 在利用我国人类遗传资
research content, cooperation term or any other major matter in the course of scientific 源开展国际合作科学研究过程中，合
research through international cooperation by using China's human genetic resources, 作方、研究目的、研究内容、合作期
modification approval formalities shall be undergone. 限等重大事项发生变更的，应当办理
变更审批手续。

Article 24 Where scientific research is conducted through international cooperation by 第二十四条 利用我国人类遗传资源
using China's human genetic resources, it shall be guaranteed that the Chinese entity 开展国际合作科学研究，应当保证中
and its researchers essentially participate in research in the entire process of 方单位及其研究人员在合作期间全过
cooperation. All records and data information in the research process, among others, 程、实质性地参与研究，研究过程中
shall be completely open to the Chinese entity and backup shall be provided to the 的所有记录以及数据信息等完全向中
Chinese entity. 方单位开放并向中方单位提供备份。

An application for the patent on the result of scientific research conducted through 利用我国人类遗传资源开展国际合作
international cooperation by using China's human genetic resources shall be jointly 科学研究，产生的成果申请专利的，

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filed by both parties to cooperation and the patent right shall be jointly owned by both 应当由合作双方共同提出申请，专利
parties to cooperation. The right to use or transfer other scientific and technological 权归合作双方共有。研究产生的其他
research achievements and interest sharing methods shall be agreed upon by both 科技成果，其使用权、转让权和利益
parties to cooperation through a cooperation agreement; if they are not agreed upon in 分享办法由合作双方通过合作协议约
the agreement, both parties to cooperation shall have the right to use, but the transfer to 定；协议没有约定的，合作双方都有
the third party shall be subject to the consent of both parties to cooperation, and the 使用的权利，但向第三方转让须经合
benefits obtained shall be shared according to the contribution made by both parties to 作双方同意，所获利益按合作双方贡
cooperation. 献大小分享。

Article 25 Where scientific research is conducted through international cooperation by 第二十五条 利用我国人类遗传资源
using China's human genetic resources, both parties to cooperation shall legally sign a 开展国际合作科学研究，合作双方应
cooperation agreement under the principles of equality, mutual benefit, good faith, 当按照平等互利、诚实信用、共同参
joint participation, and sharing of results, and agree on relevant matters in a specific 与、共享成果的原则，依法签订合作
and detailed manner in accordance with the provision of Article 24 of this Regulation. 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。

Article 26 Where scientific research is conducted through international cooperation by 第二十六条 利用我国人类遗传资源
using China's human genetic resources, both parties to cooperation shall jointly submit 开展国际合作科学研究，合作双方应
a report on cooperative research to the science and technology administrative 当在国际合作活动结束后 6 个月内共
department of the State Council within six months after the end of international 同向国务院科学技术行政部门提交合
cooperation activities. 作研究情况报告。

Article 27 Where it is indeed necessary to transport, mail or carry the materials of 第二十七条 利用我国人类遗传资源
China's human genetic resources out of China for the purpose of conducting scientific 开展国际合作科学研究，或者因其他
research through international cooperation by using China's human genetic resources 特殊情况确需将我国人类遗传资源材
or for any other particular circumstances, the following conditions shall be met, and 料运送、邮寄、携带出境的，应当符
the certificate on the exit of materials of human genetic resources issued by the science 合下列条件，并取得国务院科学技术
and technology administrative department of the State Council shall be obtained. 行政部门出具的人类遗传资源材料出
境证明：

(1) It causes no harm to China's public health, national security and public interest. （一）对我国公众健康、国家安全和
社会公共利益没有危害；

(2) The entity has the legal person status. （二）具有法人资格；

(3) There is a specific overseas partner and reasonable exit use. （三）有明确的境外合作方和合理的
出境用途；

(4) The materials of human genetic resources are legally collected or from a legal （四）人类遗传资源材料采集合法或
preservation entity. 者来自合法的保藏单位；

(5) It has passed the ethical review. （五）通过伦理审查。

Where it is necessary to transport, mail or carry the materials of China's human genetic 利用我国人类遗传资源开展国际合作
resources out of China for the purpose of conducting scientific research through 科学研究，需要将我国人类遗传资源
international cooperation by using China's human genetic resources, an application 材料运送、邮寄、携带出境的，可以
may be filed separately, or an application may be filed in the exit plan set forth in the 单独提出申请，也可以在开展国际合
application for scientific research through international cooperation, which shall be 作科学研究申请中列明出境计划一并

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subject to approval by the science and technology administrative department of the 提出申请，由国务院科学技术行政部
State Council. 门合并审批。

Where the materials of China's human genetic resources are transported, mailed or 将我国人类遗传资源材料运送、邮寄、
carried out of China, customs formalities shall be undergone based on the certificate of 携带出境的，凭人类遗传资源材料出
exit of materials of human genetic resources. 境证明办理海关手续。

Article 28 The provision or opening for use of information on human genetic 第二十八条 将人类遗传资源信息向
resources to foreign organizations and individuals and institutions formed or actually 外国组织、个人及其设立或者实际控
controlled by them shall not endanger China's public health, national security and 制的机构提供或者开放使用，不得危
public interest; and if it may affect China's public health, national security and public 害我国公众健康、国家安全和社会公
interest, it shall pass the security review organized by the science and technology 共利益；可能影响我国公众健康、国
administrative department of the State Council. 家安全和社会公共利益的，应当通过
国务院科学技术行政部门组织的安全
审查。

Where information on human genetic resources is provided or opened for use to a 将人类遗传资源信息向外国组织、个
foreign organizations or individual or an institution formed or actually controlled by it 人及其设立或者实际控制的机构提供
or him, it shall be reported to the science and technology administrative department of 或者开放使用的，应当向国务院科学
the State Council for recordation and information shall be submitted for backup. 技术行政部门备案并提交信息备份。

Information on human genetic resources generated in scientific research conducted 利用我国人类遗传资源开展国际合作

through international cooperation by using China's human genetic resources may be 科学研究产生的人类遗传资源信息，
used by both parties to cooperation. 合作双方可以使用。

Chapter IV Services and Supervision 第四章 服务和监督

Article 29 The science and technology administrative department of the State Council 第二十九条 国务院科学技术行政部
shall strengthen e-government construction, so as to facilitate applicants' handling of 门应当加强电子政务建设，方便申请
such matters as approval and recordation through the Internet. 人利用互联网办理审批、备案等事项。

Article 30 The science and technology administrative department of the State Council 第三十条 国务院科学技术行政部门
shall develop and issue in a timely manner approval guidelines and model texts on the 应当制定并及时发布有关采集、保藏、
collection, preservation, utilization and external provision of China's human genetic 利用、对外提供我国人类遗传资源的
resources, and strengthen the guidance for applicants' handling of such matters as 审批指南和示范文本，加强对申请人
approval and recordation. 办理有关审批、备案等事项的指导。

Article 31 The science and technology administrative department of the State Council 第三十一条 国务院科学技术行政部
shall retain experts in biotechnology, medicine, health, ethics, law and other aspects to 门应当聘请生物技术、医药、卫生、
form an expert review committee to conduct technical review of the applications for 伦理、法律等方面的专家组成专家评
the collection and preservation of China's human genetic resources, scientific research 审委员会，对依照本条例规定提出的
through international cooperation, and the transport, mailing and carriage of materials 采集、保藏我国人类遗传资源，开展
of China's human genetic resources out of China filed in accordance with the 国际合作科学研究以及将我国人类遗
provisions of this Regulation. Review opinions shall be taken as the basis for making 传资源材料运送、邮寄、携带出境的
approval decisions. 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。

Article 32 The science and technology administrative department of the State Council 第三十二条 国务院科学技术行政部

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shall, within 20 working days after accepting an application for the collection or 门应当自受理依照本条例规定提出的
preservation of China's human genetic resources, scientific research through 采集、保藏我国人类遗传资源，开展
international cooperation, or the transport, mailing or carriage of materials of China's 国际合作科学研究以及将我国人类遗
human genetic resources out of China filed in accordance with the provisions of this 传资源材料运送、邮寄、携带出境申
Regulation, make a decision to approve or disapprove the application; if it makes a 请之日起 20 个工作日内，作出批准或
decision on disapproval, it shall state the reasons. If it is unable to make a decision on 者不予批准的决定；不予批准的，应
approval within the prescribed time limit due to any particular reason, the period may 当说明理由。因特殊原因无法在规定
be extended by 10 working days with the approval of the person in charge of the 期限内作出审批决定的，经国务院科
science and technology administrative department of the State Council. 学技术行政部门负责人批准，可以延
长 10 个工作日。

Article 33 The science and technology administrative department of the State Council 第三十三条 国务院科学技术行政部
and science and technology administrative departments of people's governments of 门和省、自治区、直辖市人民政府科
provinces, autonomous regions and municipalities directly under the Central 学技术行政部门应当加强对采集、保
Government shall strengthen the supervision and inspection of all links of the 藏、利用、对外提供人类遗传资源活
collection, preservation, utilization and external provision of human genetic resources, 动各环节的监督检查，发现违反本条
and if they find any violation of this Regulation, shall legally handle the violation in a 例规定的，及时依法予以处理并向社
timely manner and release to the public inspection and handling results. 会公布检查、处理结果。

Article 34 The science and technology administrative department of the State Council 第三十四条 国务院科学技术行政部
and science and technology administrative departments of people's governments of 门和省、自治区、直辖市人民政府科
provinces, autonomous regions and municipalities directly under the Central 学技术行政部门进行监督检查，可以
Government may take the following measures to conduct supervision and inspection: 采取下列措施：

(1) Conducting on-site inspection. （一）进入现场检查；

(2) Inquiring of relevant personnel. （二）询问相关人员；

(3) Consulting and copying relevant materials. （三）查阅、复制有关资料；

(4) Sealing up and detaining relevant human genetic resources. （四）查封、扣押有关人类遗传资源。

Article 35 Any entity or individual shall have the right to file a complaint or report 第三十五条 任何单位和个人对违反
against any violation of this Regulation with the science and technology administrative 本条例规定的行为，有权向国务院科
department of the State Council or the science and technology administrative 学技术行政部门和省、自治区、直辖
department of the people's government of the province, autonomous region or 市人民政府科学技术行政部门投诉、
municipality directly under the Central Government. 举报。

The science and technology administrative department of the State Council and science 国务院科学技术行政部门和省、自治
and technology administrative departments of people's governments of provinces, 区、直辖市人民政府科学技术行政部
autonomous regions and municipalities directly under the Central Government shall 门应当公布投诉、举报电话和电子邮
publish the hotline for filing complaints and reports and e-mail address, and accept 件地址，接受相关投诉、举报。对查
relevant complaints and reports. If the violation is found to be true upon investigation, 证属实的，给予举报人奖励。
the informer shall be given a reward.

Chapter V Legal Liability 第五章 法律责任

Article 36 Where anyone falls under any of following circumstances in violation of 第三十六条 违反本条例规定，有下
this Regulation, the science and technology administrative department of the State 列情形之一的，由国务院科学技术行

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Council shall order the suspension of the violation of law, confiscate the illegally 政部门责令停止违法行为，没收违法
collected and preserved human genetic resources and illegal income, and impose a fine 采集、保藏的人类遗传资源和违法所
of not less than 500,000 yuan but not more than five million yuan on the violator, or if 得，处 50 万元以上 500 万元以下罚款，
the illegal income is one million yuan or more, impose a fine of not less than five times 违法所得在 100 万元以上的，处违法
but not more than 10 times the illegal income on the violator: 所得 5 倍以上 10 倍以下罚款：

(1) Collecting China's human genetic resources of important genetic families and （一）未经批准，采集我国重要遗传
specific regions without approval, or collecting human genetic resources of the types 家系、特定地区人类遗传资源，或者
and quantities prescribed by the science and technology administrative department of 采集国务院科学技术行政部门规定种
the State Council. 类、数量的人类遗传资源；

(2) Preserving China's human genetic resources without approval. （二）未经批准，保藏我国人类遗传

资源；

(3) Conducting scientific research through international cooperation by using China's （三）未经批准，利用我国人类遗传
human genetic resources without approval. 资源开展国际合作科学研究；

(4) Providing or opening for use the information on human genetic resources that may （四）未通过安全审查，将可能影响
affect China's public health, national security and public interest to any foreign 我国公众健康、国家安全和社会公共
organization or individual or any institution formed or actually controlled by it or him 利益的人类遗传资源信息向外国组织、
without passing security review. 个人及其设立或者实际控制的机构提
供或者开放使用；

(5) Failing to submit the type, quantity and use of human genetic resources to be used （五）开展国际合作临床试验前未将
to the science and technology administrative department of the State Council for 拟使用的人类遗传资源种类、数量及
recordation before conducting clinical trials through international cooperation. 其用途向国务院科学技术行政部门备
案。

Article 37 Where anyone provides false materials or obtains administrative licensing 第三十七条 提供虚假材料或者采取
by any other deceptive means, the science and technology administrative department 其他欺骗手段取得行政许可的，由国
of the State Council shall revoke the administrative license that has been obtained, 务院科学技术行政部门撤销已经取得
impose a fine of not less than 500,000 yuan but not more than five million yuan on the 的行政许可，处 50 万元以上 500 万元
violator, and shall not accept the licensing application filed by the relevant person in 以下罚款，5 年内不受理相关责任人及
charge and entity within five years. 单位提出的许可申请。

Article 38 Whoever, in violation of this Regulation, transports, mails or carries the 第三十八条 违反本条例规定，未经
materials of China's human genetic resources out of China without approval shall be 批准将我国人类遗传资源材料运送、
punished by the customs office in accordance with the provisions of laws and 邮寄、携带出境的，由海关依照法律、
administrative regulations. The science and technology administrative department shall 行政法规的规定处罚。科学技术行政
cooperate with the customs office in conducting identification and other law 部门应当配合海关开展鉴定等执法协
enforcement assistance work. The customs office shall transfer the materials of human 助工作。海关应当将依法没收的人类
genetic resources confiscated in accordance with the law to the science and technology 遗传资源材料移送省、自治区、直辖
administrative department of the people's government of the province, autonomous 市人民政府科学技术行政部门进行处
region or municipality directly under the Central Government for handling. 理。

Article 39 Where anyone falls under any of the following circumstances in violation of 第三十九条 违反本条例规定，有下
this Regulation, the science and technology administrative department of the people's 列情形之一的，由省、自治区、直辖
government of the province, autonomous region or municipality directly under the 市人民政府科学技术行政部门责令停
Central Government shall order the suspension of relevant activities, confiscate the 止开展相关活动，没收违法采集、保

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illegally collected and preserved human genetic resources and illegal income, and 藏的人类遗传资源和违法所得，处
impose a fine of not less than 500,000 yuan but not more than one million yuan on the 50 万元以上 100 万元以下罚款，违法
violator, or if the illegal income is one million yuan or more, impose a fine of not less 所得在 100 万元以上的，处违法所得
than five times but not more than 10 times the illegal income on the violator: 5 倍以上 10 倍以下罚款：

(1) Collecting, preserving, utilizing or providing to the outside China's human genetic （一）采集、保藏、利用、对外提供
resources without passing ethical review. 我国人类遗传资源未通过伦理审查；

(2) Collecting China's human genetic resources without obtaining the prior consent of （二）采集我国人类遗传资源未经人
the human genetic resource provider, or obtaining the consent of the human genetic 类遗传资源提供者事先知情同意，或
resource provider by such means as concealment, misleading and deception. 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；

(3) Collecting, preserving, utilizing or providing to the outside China's human genetic （三）采集、保藏、利用、对外提供
resources in violation of relevant technical specifications. 我国人类遗传资源违反相关技术规范；

(4) Providing or opening for use the information on human genetic resources to any （四）将人类遗传资源信息向外国组
foreign organization or individual or any institution formed or actually controlled by it 织、个人及其设立或者实际控制的机
or him without reporting it to the science and technology administrative department of 构提供或者开放使用，未向国务院科
the State Council for recordation or submitting the information for backup. 学技术行政部门备案或者提交信息备
份。

Article 40 Where anyone falls under any of the following circumstances in violation of 第四十条 违反本条例规定，有下列
this Regulation, the science and technology administrative department of the State 情形之一的，由国务院科学技术行政
Council shall order it to take corrective action and give it a warning, and may impose a 部门责令改正，给予警告，可以处
fine of not more than 500,000 yuan on it: 50 万元以下罚款：

(1) Failing to fully record and properly preserve the information on the source and use （一）保藏我国人类遗传资源过程中
of human genetic resources in the process of preserving China's human genetic 未完整记录并妥善保存人类遗传资源
resources. 的来源信息和使用信息；

(2) Failing to submit an annual report on the preservation of China's human genetic （二）保藏我国人类遗传资源未提交
resources. 年度报告；

(3) Failing to submit a report on cooperative research in a timely manner when （三）开展国际合作科学研究未及时
conducting scientific research through international cooperation. 提交合作研究情况报告。

Article 41 Where a foreign organization or individual or an institution formed or 第四十一条 外国组织、个人及其设

actually controlled by it or him, in violation of this Regulation, collects and preserves 立或者实际控制的机构违反本条例规
China's human genetic resources within the territory of China, uses China's human 定，在我国境内采集、保藏我国人类
genetic resources to conduct scientific research, or provides China's human genetic 遗传资源，利用我国人类遗传资源开
resources abroad, the science and technology administrative department of the State 展科学研究，或者向境外提供我国人
Council shall order it to cease the violation of law, confiscate illegally collected and 类遗传资源的，由国务院科学技术行
preserved human genetic resources and illegal income, and impose a fine of not less 政部门责令停止违法行为，没收违法
than one million yuan but not more than 10 million yuan on the violator, or if the 采集、保藏的人类遗传资源和违法所
illegal income is one million yuan or more, impose a fine of not less than five times 得，处 100 万元以上 1000 万元以下罚
but not more than 10 times the illegal income on the violator. 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。

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Article 42 Where anyone trades in human genetic resources in violation of this 第四十二条 违反本条例规定，买卖
Regulation, the science and technology administrative department of the State Council 人类遗传资源的，由国务院科学技术
shall order it to cease the violation of law, confiscate the illegally collected and 行政部门责令停止违法行为，没收违
preserved human genetic resources and illegal income, and impose a fine of not less 法采集、保藏的人类遗传资源和违法
than one million yuan but not more than ten million yuan on the violator, or if the 所得，处 100 万元以上 1000 万元以下
illegal income is one million yuan or more, impose a fine of not less than five times 罚款，违法所得在 100 万元以上的，
but not more than 10 times the illegal income on the violator. 处违法所得 5 倍以上 10 倍以下罚款。

Article 43 Where any entity commits any violation of law set forth in Article 36, 39, 第四十三条 对有本条例第三十六条、
41 or 42 of this Regulation, and the circumstances are serious, the science and 第三十九条、第四十一条、第四十二
technology administrative department of the State Council or the science and 条规定违法行为的单位，情节严重的，
technology administrative department of the people's government of the province, 由国务院科学技术行政部门或者省、
autonomous region or municipality directly under the Central Government shall, 自治区、直辖市人民政府科学技术行
according to its functions and powers, prohibit its collection, preservation, utilization 政部门依据职责禁止其 1 至 5 年内从
and external provision of China's human genetic resources within one to five years; or 事采集、保藏、利用、对外提供我国
if the circumstances are particularly serious, prohibit its collection, preservation, 人类遗传资源的活动；情节特别严重
utilization and external provision of China's human genetic resources permanently. 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。

The legal representative, the principal person in charge, the directly responsible person 对有本条例第三十六条至第三十九条、
in charge and other liable persons of an entity that commits any violation of law set 第四十一条、第四十二条规定违法行
forth in Article 36 to 39, 41 or 42 of this Regulation shall be given disciplinary actions 为的单位的法定代表人、主要负责人、
in accordance with the law, and the science and technology administrative department 直接负责的主管人员以及其他责任人
of the State Council or the science and technology administrative department of the 员，依法给予处分，并由国务院科学
people's government of the province, autonomous region or municipality directly 技术行政部门或者省、自治区、直辖
under the Central Government shall, according to its functions and powers, confiscate 市人民政府科学技术行政部门依据职
their illegal income and impose a fine of not more than 500,000 yuan on them; if the 责没收其违法所得，处 50 万元以下罚
circumstances are serious, prohibit their collection, preservation, utilization and 款；情节严重的，禁止其 1 至 5 年内
external provision of China's human genetic resources within one to five years; or if 从事采集、保藏、利用、对外提供我
the circumstances are particularly serious, prohibit their collection, preservation, 国人类遗传资源的活动；情节特别严
utilization and external provision of China's human genetic resources permanently. 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。

Where an entity or individual commits any violation of law prescribed in this 单位和个人有本条例规定违法行为的，
Regulation, the violation shall be included in credit records and published in 记入信用记录，并依照有关法律、行
accordance with the provisions of relevant laws and administrative regulations. 政法规的规定向社会公示。

Article 44 Whoever infringes upon any other person's lawful rights and interests in 第四十四条 违反本条例规定，侵害
violation of this Regulation shall assume civil liability in accordance with the law; and 他人合法权益的，依法承担民事责任；
if the violation constitutes a crime, the violator shall be subject to criminal liability in 构成犯罪的，依法追究刑事责任。
accordance with the law.

Article 45 Where any staff member of the science and technology administrative 第四十五条 国务院科学技术行政部
department of the State Council or the science and technology administrative 门和省、自治区、直辖市人民政府科
department of the people's government of the province, autonomous region or 学技术行政部门的工作人员违反本条

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municipality directly under the Central Government, in violation of this Regulation, 例规定，不履行职责或者滥用职权、
fails to perform functions, or abuses power, neglects duty, practices favoritism, or 玩忽职守、徇私舞弊的，依法给予处
makes falsification, the staff member shall be given disciplinary actions in accordance 分；构成犯罪的，依法追究刑事责任。
with the law. If the case constitutes a crime, the staff member shall be subject to
criminal liability in accordance with the law.

Chapter VI Supplementary Provisions 第六章 附 则

Article 46 Where the information relating to human genetic resources is a state secret, 第四十六条 人类遗传资源相关信息
it shall be subject to confidentiality management in accordance with the Law of the 属于国家秘密的，应当依照《中华人
People's Republic of China on Guarding State Secrets and other provisions of the state 民共和国保守国家秘密法》和国家其
on confidentiality. 他有关保密规定实施保密管理。

Article 47 This Regulation shall come into force on July 1, 2019. 第四十七条 本条例自 2019 年 7 月
1 日起施行。

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