Promulgated by: State Council of the People’s Republic of China. Document No.: State Council Decree No. 717 (国务院令第717号). Adopted on May 28, 2019; promulgated on June 10, 2019. Effective July 1, 2019. Amended by: Decision of the State Council on Revising and Abolishing Certain Administrative Regulations, March 10, 2024 (transferring primary administrative authority from the Ministry of Science and Technology to the National Health Commission and provincial-level health authorities).
Chapter I General Provisions
Article 1. These Regulations are formulated in order to effectively protect and rationally utilize China’s human genetic resources, and to safeguard public health, national security, and the public interest of society.
Article 2. For the purposes of these Regulations, “human genetic resources” includes human genetic resource materials and human genetic resource information.
“Human genetic resource materials” means genetic materials such as organs, tissues, and cells that contain genetic substances such as the human genome and genes.
“Human genetic resource information” means data and other information produced by utilizing human genetic resource materials.
Article 3. Collection, preservation, utilization, and provision abroad of China’s human genetic resources shall comply with these Regulations.
The collection and preservation of bodily substances such as organs, tissues, and cells, and the conduct of related activities, required for purposes such as clinical diagnosis and treatment, blood collection and supply services, investigation and handling of illegal and criminal acts, doping testing, and funeral services, shall be carried out in accordance with the relevant laws and administrative regulations.
Article 4. The competent health authority of the State Council is responsible for the administration of human genetic resources nationwide; other relevant departments of the State Council are responsible for the administration of relevant human genetic resources within the scope of their respective duties.
The human genetic resources competent authority of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government is responsible for the administration 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 are responsible for the administration of relevant human genetic resources within their respective administrative regions within the scope of their respective duties.
Article 5. The State strengthens the protection of China’s human genetic resources, conducts investigations of human genetic resources, and implements a declaration and registration system for human genetic resources from important genetic families and specific regions.
The competent health authority of the State Council is responsible for organizing investigations of China’s human genetic resources, and formulating specific measures for the declaration and registration of human genetic resources from important genetic families and specific regions.
Article 6. The State supports the rational utilization of human genetic resources to conduct scientific research, develop the biopharmaceutical industry, and improve diagnostic and treatment technologies, so as to enhance China’s biosecurity capacity and improve the level of protection of public health.
Article 7. Foreign organizations, individuals, and institutions established or actually controlled by foreign organizations or individuals shall not collect or preserve China’s human genetic resources within China’s territory, nor shall they provide China’s human genetic resources abroad.
Article 8. The collection, preservation, utilization, and provision abroad of China’s human genetic resources shall not endanger China’s public health, national security, or the public interest of society.
Article 9. The collection, preservation, utilization, and provision abroad of China’s human genetic resources shall comply with ethical principles and shall undergo ethical review in accordance with relevant State provisions.
The collection, preservation, utilization, and provision abroad of China’s human genetic resources shall respect the privacy rights of human genetic resource providers, obtain their prior informed consent, and protect their lawful rights and interests.
The collection, preservation, utilization, and provision abroad of China’s human genetic resources shall comply with the technical standards formulated by the competent health authority of the State Council.
Article 10. The purchase and sale of human genetic resources is prohibited.
The lawful provision or use of human genetic resources for scientific research and the payment or receipt of reasonable cost fees shall not be regarded as purchase and sale.
Chapter II Collection and Preservation
Article 11. Where it is necessary to collect human genetic resources from important genetic families or specific regions within China, or to collect types or quantities of human genetic resources as stipulated by the competent health authority of the State Council, the following conditions shall be met and approval of the competent health authority of the State Council shall be obtained:
(1) having the status of a legal person;
(2) having a clear and lawful purpose for collection;
(3) having a reasonable collection plan;
(4) having passed ethical review;
(5) having a department and management system responsible for the administration of human genetic resources; and
(6) having premises, facilities, equipment, and personnel commensurate with the collection activities.
Article 12. When collecting China’s human genetic resources, the collector shall, in advance, inform the human genetic resource providers of the purpose of collection, the intended use of the collection, the possible effects on health, the personal privacy protection measures, and their rights to participate voluntarily and to withdraw unconditionally at any time, and shall obtain the written consent of the human genetic resource providers.
When informing the human genetic resource providers of the information specified in the preceding paragraph, the information must be comprehensive, complete, truthful, and accurate; concealment, misleading, and deception are prohibited.
Article 13. The State strengthens the preservation of human genetic resources and accelerates the development of standardized and normalized human genetic resource preservation infrastructure platforms and human genetic resource big data systems, in order to provide support for the conduct of related research and development activities.
The State encourages scientific research institutions, universities, medical institutions, and enterprises to carry out human genetic resource preservation work in accordance with their own conditions and the needs of related research and development activities, and to provide convenience for other entities in conducting related research and development activities.
Article 14. Where it is necessary to preserve China’s human genetic resources and provide a basic platform for scientific research, the following conditions shall be met and approval of the competent health authority of the State Council shall be obtained:
(1) having the status of a legal person;
(2) having a clear and lawful purpose for preservation;
(3) having a reasonable preservation plan;
(4) having human genetic resources to be preserved that come from lawful sources;
(5) having passed ethical review;
(6) having a department and preservation management system responsible for the administration of human genetic resources; and
(7) having premises, facilities, equipment, and personnel that meet the national technical standards and requirements for human genetic resource preservation.
Article 15. Preservation entities shall strengthen the administration and monitoring of the human genetic resources they preserve, adopt security measures, and formulate emergency response plans to ensure the safety of preservation and use.
Preservation entities shall completely record the preservation status of human genetic resources, and properly keep source information and use information of human genetic resources, in order to ensure the lawful use of human genetic resources.
Preservation entities shall submit annual reports on the preservation of human genetic resources by their entities to the competent health authority of the State Council.
Article 16. National human genetic resource preservation infrastructure platforms and databases shall be made open to relevant scientific research institutions, universities, medical institutions, and enterprises in accordance with relevant State provisions.
Where required for the needs of public health, national security, and the public interest of society, the State may, in accordance with law, use human genetic resources preserved by preservation entities.
Chapter III Utilization and Provision Abroad
Article 17. The competent health authority of the State Council and the human genetic resources competent authorities 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 plans for and reasonable arrangements of scientific research and biopharmaceutical industry development conducted by utilizing human genetic resources, strengthen the development of innovation systems, and promote the innovation and coordinated development of biotechnology and industries.
Article 18. Scientific research institutions, universities, medical institutions, and enterprises that conduct research and development activities by utilizing human genetic resources shall receive support in accordance with laws, administrative regulations, and relevant State provisions for their research and development activities and the industrialization of their results.
Article 19. The State encourages scientific research institutions, universities, medical institutions, and enterprises to utilize China’s human genetic resources for international cooperative scientific research in accordance with their own conditions and the needs of related research and development activities, in order to enhance the capacity and level of relevant research and development.
Article 20. The conduct of biotechnology research and development activities or clinical trials utilizing China’s human genetic resources shall comply with the laws, administrative regulations, and relevant State provisions on the administration of biotechnology research and clinical application.
Article 21. Foreign organizations and institutions established or actually controlled by foreign organizations or individuals (hereinafter referred to as “foreign parties”) that need to utilize China’s human genetic resources for scientific research activities shall comply with China’s laws, administrative regulations, and relevant State provisions, and shall proceed by way of cooperation with scientific research institutions, universities, medical institutions, or enterprises in China (hereinafter referred to as “Chinese parties”).
Article 22. The conduct of international cooperative scientific research utilizing China’s human genetic resources shall meet the following conditions, and a joint application shall be submitted by both cooperative parties, subject to approval by the competent health authority of the State Council:
(1) posing no threat to China’s public health, national security, or the public interest of society;
(2) both cooperative parties being Chinese parties and foreign parties with the status of legal persons that have the foundation and capacity to undertake the relevant work;
(3) having clear and lawful purposes and content for the cooperative research and a reasonable duration;
(4) having a reasonable cooperative research plan;
(5) the human genetic resources to be used having lawful sources, and the types and quantities being consistent with the research content;
(6) having passed ethical review in the respective countries (regions) of both cooperative parties; and
(7) having clearly defined ownership of research results and a reasonable and clear benefit-sharing plan.
For the purpose of obtaining marketing authorization in China for relevant drugs and medical devices, international cooperative clinical trials conducted in clinical institutions utilizing China’s human genetic resources and not involving the export of human genetic resource materials shall not require approval. However, before commencing clinical trials, both cooperative parties shall file with the competent health authority of the State Council the types, quantities, and intended uses of the human genetic resources to be utilized. The competent health authority of the State Council and the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen supervision of the matters filed.
Article 23. Where, in the course of international cooperative scientific research utilizing China’s human genetic resources, there is a significant change in the cooperative parties, the purpose of research, the content of research, the duration of cooperation, or other significant matters, the procedures for approval of the change shall be completed.
Article 24. In international cooperative scientific research utilizing China’s human genetic resources, it shall be ensured that Chinese party entities and their research personnel participate throughout and substantively in the research during the cooperation period, and all records and data and information generated during the research process shall be fully accessible to the Chinese party entity and a copy shall be provided to the Chinese party entity.
In international cooperative scientific research utilizing China’s human genetic resources, where an application for a patent is made for results produced, the application shall be jointly submitted by both cooperative parties, and the patent right shall be jointly owned by both cooperative parties. With respect to other scientific and technological results produced by the research, the rights of use, transfer rights, and benefit-sharing arrangements shall be agreed upon by the cooperative parties through a cooperation agreement; where the agreement makes no provision, both cooperative parties shall have the right of use, but transfer to a third party shall require the consent of both cooperative parties, and the benefits obtained shall be shared in accordance with the contributions of the cooperative parties.
Article 25. In international cooperative scientific research utilizing China’s human genetic resources, both cooperative parties shall, in accordance with the principles of equality and mutual benefit, good faith, joint participation, and sharing of results, sign a cooperation agreement in accordance with law and make clear and specific provisions on the relevant matters in accordance with Article 24 of these Regulations.
Article 26. In international cooperative scientific research utilizing China’s human genetic resources, both cooperative parties shall jointly submit a report on the cooperative research activities to the competent health authority of the State Council within 6 months after the conclusion of the international cooperative activities.
Article 27. Where, in the course of international cooperative scientific research utilizing China’s human genetic resources, or due to other special circumstances, it is necessary to transport, mail, or carry China’s human genetic resource materials out of China, the following conditions shall be met and an outbound certificate for human genetic resource materials shall be obtained from the competent health authority of the State Council:
(1) posing no threat to China’s public health, national security, or the public interest of society;
(2) having the status of a legal person;
(3) having a clear overseas cooperative party and a reasonable purpose for taking the materials abroad;
(4) the human genetic resource materials having been lawfully collected or coming from a lawful preservation entity; and
(5) having passed ethical review.
Where, in the course of international cooperative scientific research utilizing China’s human genetic resources, it is necessary to transport, mail, or carry China’s human genetic resource materials out of China, the application may be submitted separately or may be submitted together with the application for conducting international cooperative scientific research, with the plan for taking materials abroad listed therein, and the competent health authority of the State Council shall consolidate the approval.
Where China’s human genetic resource materials are transported, mailed, or carried out of China, customs procedures shall be completed on the basis of the outbound certificate for human genetic resource materials.
Article 28. Where human genetic resource information is provided to or made available for use by foreign organizations, individuals, or institutions established or actually controlled by foreign organizations or individuals, China’s public health, national security, and the public interest of society shall not be endangered; where it may affect China’s public health, national security, or the public interest of society, a security review organized by the competent health authority of the State Council shall be completed.
Where human genetic resource information is provided to or made available for use by foreign organizations, individuals, or institutions established or actually controlled by foreign organizations or individuals, the matter shall be filed with the competent health authority of the State Council and a copy of the information shall be submitted.
Human genetic resource information produced in international cooperative scientific research utilizing China’s human genetic resources may be used by both cooperative parties.
Chapter IV Services and Supervision
Article 29. The competent health authority of the State Council shall strengthen the development of e-government to facilitate applicants’ use of the Internet to handle approval, filing, and other matters.
Article 30. The competent health authority of the State Council shall formulate and promptly publish approval guides and model texts for the collection, preservation, utilization, and provision abroad of China’s human genetic resources, and shall strengthen guidance to applicants in handling relevant approval, filing, and other matters.
Article 31. The competent health authority 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 review of applications submitted pursuant to these Regulations for the collection and preservation of China’s human genetic resources, the conduct of international cooperative scientific research, and the transport, mailing, or carrying of China’s human genetic resource materials out of China. The review opinions shall serve as a reference for making approval decisions.
Article 32. The competent health authority of the State Council shall, within 20 working days from the date of acceptance of applications submitted pursuant to these Regulations for the collection and preservation of China’s human genetic resources, the conduct of international cooperative scientific research, and the transport, mailing, or carrying of China’s human genetic resource materials out of China, make a decision to approve or disapprove; where disapproval is decided, reasons shall be stated. Where, due to special circumstances, it is impossible to make an approval decision within the prescribed time limit, the time limit may be extended by 10 working days upon approval by the person in charge of the competent health authority of the State Council.
Article 33. The competent health authority of the State Council and the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen supervision and inspection of all aspects of activities involving the collection, preservation, utilization, and provision abroad of human genetic resources; where violations of these Regulations are discovered, they shall be dealt with promptly in accordance with law, and the results of inspections and handling shall be published to the public.
Article 34. The competent health authority of the State Council and the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government may, in conducting supervision and inspection, adopt the following measures:
(1) entering the premises for inspection;
(2) inquiring of relevant personnel;
(3) consulting and copying relevant materials; and
(4) sealing up and impounding relevant human genetic resources.
Article 35. Any entity or individual has the right to file complaints and reports with the competent health authority of the State Council and the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government regarding violations of these Regulations.
The competent health authority of the State Council and the human genetic resources competent authorities 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, and accept the relevant complaints and reports. Those that are verified upon investigation shall be awarded to the informant.
Chapter V Legal Liability
Article 36. Where, in violation of these Regulations, any of the following circumstances exists, the competent health authority of the State Council shall order the cessation of the illegal act, confiscate the illegally collected and preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 500,000 and not more than RMB 5,000,000; where the illegal gains are RMB 1,000,000 or more, a fine of not less than five times and not more than ten times the illegal gains shall be imposed:
(1) without approval, collecting human genetic resources from important genetic families or specific regions of China, or collecting types or quantities of human genetic resources as stipulated by the competent health authority of the State Council;
(2) without approval, preserving China’s human genetic resources;
(3) without approval, utilizing China’s human genetic resources to conduct international cooperative scientific research;
(4) without passing a security review, providing or making available for use human genetic resource information that may affect China’s public health, national security, or the public interest of society to foreign organizations, individuals, or institutions established or actually controlled by foreign organizations or individuals; or
(5) failing to file with the competent health authority of the State Council the types, quantities, and intended uses of the human genetic resources to be utilized before commencing international cooperative clinical trials.
Article 37. Where false materials are provided or other deceptive means are used to obtain an administrative permit, the competent health authority of the State Council shall revoke the administrative permit already obtained, impose a fine of not less than RMB 500,000 and not more than RMB 5,000,000, and shall not accept permit applications from the responsible persons and entities within 5 years.
Article 38. Where, in violation of these Regulations, China’s human genetic resource materials are transported, mailed, or carried out of China without approval, customs shall impose punishment in accordance with the provisions of the relevant laws and administrative regulations. The human genetic resources competent authority shall cooperate with customs in conducting identification and other law enforcement assistance work. Customs shall transfer the human genetic resource materials confiscated in accordance with law to the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government for disposal.
Article 39. Where, in violation of these Regulations, any of the following circumstances exists, the human genetic resources competent authority of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order the cessation of the relevant activities, confiscate the illegally collected and preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 500,000 and not more than RMB 1,000,000; where the illegal gains are RMB 1,000,000 or more, a fine of not less than five times and not more than ten times the illegal gains shall be imposed:
(1) failing to pass ethical review in the collection, preservation, utilization, or provision abroad of China’s human genetic resources;
(2) collecting China’s human genetic resources without obtaining the prior informed consent of the human genetic resource providers, or obtaining the consent of the human genetic resource providers through means such as concealment, misleading, or deception;
(3) violating relevant technical standards in the collection, preservation, utilization, or provision abroad of China’s human genetic resources; or
(4) providing or making available for use human genetic resource information to foreign organizations, individuals, or institutions established or actually controlled by foreign organizations or individuals without filing with the competent health authority of the State Council or submitting a copy of the information.
Article 40. Where, in violation of these Regulations, any of the following circumstances exists, the competent health authority of the State Council shall order rectification, issue a warning, and may impose a fine of not more than RMB 500,000:
(1) failing to completely record and properly keep source information and use information of human genetic resources in the course of preserving China’s human genetic resources;
(2) failing to submit annual reports on the preservation of China’s human genetic resources; or
(3) failing to submit reports on cooperative research activities in a timely manner upon completion of international cooperative scientific research.
Article 41. Where foreign organizations, individuals, or institutions established or actually controlled by foreign organizations or individuals violate these Regulations by collecting or preserving China’s human genetic resources within China, utilizing China’s human genetic resources to conduct scientific research, or providing China’s human genetic resources abroad, the competent health authority of the State Council shall order the cessation of the illegal act, confiscate the illegally collected and preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 1,000,000 and not more than RMB 10,000,000; where the illegal gains are RMB 1,000,000 or more, a fine of not less than five times and not more than ten times the illegal gains shall be imposed.
Article 42. Where, in violation of these Regulations, human genetic resources are bought or sold, the competent health authority of the State Council shall order the cessation of the illegal act, confiscate the illegally collected and preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 1,000,000 and not more than RMB 10,000,000; where the illegal gains are RMB 1,000,000 or more, a fine of not less than five times and not more than ten times the illegal gains shall be imposed.
Article 43. With respect to entities that have committed illegal acts as provided for in Articles 36, 39, 41, and 42 of these Regulations, where the circumstances are serious, the competent health authority of the State Council or the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their duties, prohibit the entities from engaging in activities of collecting, preserving, utilizing, and providing abroad China’s human genetic resources for a period of 1 to 5 years; where the circumstances are particularly serious, the entities shall be permanently prohibited from engaging in such activities.
With respect to the legal representatives, principal responsible persons, persons directly in charge, and other responsible persons of entities that have committed illegal acts as provided for in Articles 36 through 39, 41, and 42 of these Regulations, sanctions shall be imposed in accordance with law, and the competent health authority of the State Council or the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their duties, confiscate their illegal gains and impose a fine of not more than RMB 500,000; where the circumstances are serious, such persons shall be prohibited from engaging in activities of collecting, preserving, utilizing, and providing abroad China’s human genetic resources for a period of 1 to 5 years; where the circumstances are particularly serious, such persons shall be permanently prohibited from engaging in such activities.
Entities and individuals that have committed illegal acts as provided for in these Regulations shall have such acts recorded in credit records and publicized to the public in accordance with the relevant laws and administrative regulations.
Article 44. Where, in violation of these Regulations, the lawful rights and interests of others are infringed, civil liability shall be borne in accordance with law; where a crime is constituted, criminal liability shall be pursued in accordance with law.
Article 45. Where staff members of the competent health authority of the State Council and the human genetic resources competent authorities of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government violate these Regulations by failing to perform their duties, or abusing their powers, neglecting their duties, or engaging in favoritism and malpractice, sanctions shall be imposed in accordance with law; where a crime is constituted, criminal liability shall be pursued in accordance with law.
Chapter VI Supplementary Provisions
Article 46. Where human genetic resource-related information 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.
Article 47. These Regulations shall come into force on July 1, 2019.