Promulgated by: Ministry of Science and Technology of the People’s Republic of China. Document No.: Order of the Ministry of Science and Technology No. 21. Adopted on May 26, 2023. Effective July 1, 2023.
Chapter I General Provisions
Article 1. These Implementing Rules are formulated in accordance with the Biosafety Law of the People’s Republic of China, the Regulation on the Administration of Human Genetic Resources of the People’s Republic of China, and other relevant laws and administrative regulations, 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. The collection, preservation, utilization, and cross-border provision of China’s human genetic resources shall comply with these Implementing Rules. Human genetic resource information includes information and data — such as human gene and genome data — generated through the use of human genetic resource materials, but excludes clinical data, imaging data, protein data, and metabolic data.
Article 3. The Ministry of Science and Technology (MOST) is responsible for the administration of human genetic resources throughout the country, including surveys, administrative licensing, supervision and inspection, and administrative penalties. MOST may, in accordance with law, entrust relevant organizations to carry out related work.
Article 4. Provincial-level science and technology administrative departments are responsible for supervision and inspection, day-to-day administration, and the handling of cases of violations within their respective jurisdictions, as well as work entrusted to them by MOST.
Article 5. MOST and provincial-level science and technology administrative departments shall strengthen their administrative capacity, equip enforcement personnel, and conduct supervision and inspection in accordance with their respective functions.
Article 6. MOST shall appoint experts to form an Expert Advisory Committee on the Administration of Human Genetic Resources to provide decision-making consultation and technical support.
Article 7. MOST supports the rational utilization of human genetic resources for scientific research, the development of the biopharmaceutical industry, and the improvement of diagnostic and treatment technologies; it shall strengthen administration and supervision, and optimize approval services.
Chapter II General Requirements
Article 8. The collection, preservation, utilization, and cross-border provision of human genetic resources shall comply with ethical principles and shall pass ethical review by a duly filed ethics committee.
Article 9. The privacy rights, personal information, and other rights and interests of human genetic resource providers shall be respected and protected, and written informed consent shall be obtained in accordance with regulations.
Article 10. Relevant requirements and technical specifications for scientific and technological activities — including standards, norms, and protocols — shall be observed.
Article 11. The collection and preservation of China’s human genetic resources within the territory of China, and the cross-border provision thereof, must be carried out by Chinese entities. Institutions incorporated in the mainland, Hong Kong, or Macao that are controlled by domestic capital shall be treated as Chinese entities. Foreign entities and overseas individuals may not collect or preserve China’s human genetic resources within the territory of China, nor provide them across borders.
Article 12. A “foreign entity” (外方单位) refers to any organization or institution in which overseas organizations or individuals hold or actually control 50% or more of the equity interests, voting rights, or other interests, or have the ability to exert a significant influence on its decision-making.
Article 13. Entities engaged in the collection, preservation, utilization, or cross-border provision of human genetic resources shall strengthen their internal management systems and review the scientific research objectives and protocols involved.
Article 14. In international scientific research collaboration, Chinese entities shall be ensured full-process, substantive participation, and shall share in the rights and interests in accordance with law. All records and data shall be fully open to and made available to the Chinese party as backups.
Article 15. MOST shall establish an information management system for the administration of human genetic resources, to enable online processing of administrative licenses, filings, and other matters, and to promote dynamic management and traceability.
Article 16. MOST shall promote the establishment of a basic platform and big-data system for the preservation of human genetic resources, and shall make it available to relevant institutions in accordance with regulations.
Article 17. In response to emergencies, MOST shall establish an expedited approval mechanism to accelerate the handling of relevant administrative licenses.
Article 18. MOST shall formulate and publish service guides and model texts for administrative licensing, filing, and other matters relating to the collection, preservation, utilization, and cross-border provision of human genetic resources.
Article 19. MOST shall regularly provide training for researchers and administrators engaged in human genetic resource activities.
Article 20. MOST and provincial-level science and technology administrative departments shall establish measures to guard against integrity risks and shall improve supervision mechanisms.
Chapter III Survey and Registration
Article 21. MOST is responsible for the national survey of human genetic resources; provincial-level science and technology administrative departments shall, as entrusted, be responsible for surveys within their respective jurisdictions.
Article 22. The national survey shall be conducted once every five years; it may be conducted as needed when circumstances require.
Article 23. MOST shall organize experts to formulate the survey work plan. Provincial-level science and technology administrative departments shall compile and submit survey data and information to MOST.
Article 24. MOST shall organize research on important genetic families and human genetic resources specific to particular regions, establish a catalogue thereof, and revise it in a timely manner.
Article 25. MOST is responsible for the registration of important genetic families and human genetic resources specific to particular regions; it shall formulate management measures and establish an information service platform therefor.
Article 26. Scientific research institutions, institutions of higher education, medical institutions, and enterprises in China that discover important genetic resources shall promptly report them through the platform.
Chapter IV Administrative Licensing and Filing
Section 1 Administrative Licensing for Collection and Preservation
Article 27. Administrative licensing for the collection of human genetic resources applies to:
(1) the collection of important genetic families (i.e., a group of blood-related individuals spanning three or more generations who suffer from a hereditary disease, excluding common diseases);
(2) collection from specific regions (i.e., populations with special physical characteristics living in isolated or special environments); and
(3) large-scale population studies (involving 3,000 or more subjects).
Collection activities conducted for clinical trials do not require licensing.
Article 28. Administrative licensing for the preservation of human genetic resources applies to activities carried out within the territory of China to store resources and provide a basic platform for scientific research. Preservation means storing human genetic resource materials with legal sources in a suitable environment; it does not include temporary storage for teaching purposes.
Article 29. Where an activity involves both preservation and collection, only a preservation license needs to be applied for.
Article 30. A preservation unit shall submit to MOST an annual report on preservation activities for the preceding year by January 31 of each year. The annual report shall include information on the preserved resources, their sources and usage, the implementation of management systems, the maintenance of facilities and premises, and changes in administrative personnel.
Section 2 Administrative Licensing and Filing for International Collaboration
Article 31. An application for a license for international scientific research collaboration shall have passed ethical review by the respective competent ethics committees of both the Chinese and foreign parties. Where the foreign party is unable to provide such evidence, it may submit supporting materials demonstrating that it accepts the Chinese party’s ethical review opinion.
Article 32. International collaborative clinical trials conducted within medical and healthcare institutions for the purpose of obtaining drug or medical device marketing authorizations — where such collaboration involves the use of China’s human genetic resources but does not involve the export of materials — do not require approval, provided that collection, testing, and analysis are carried out within the institution or by a designated domestic entity. Such activities shall, however, be filed with MOST.
Article 33. Applications for administrative licenses for international collaboration, and filings for clinical trials, shall be submitted jointly by both the Chinese and foreign parties. Multi-center clinical research may not be divided into separate applications.
Article 34. For multi-center clinical research, the lead institution shall obtain the license or complete the filing; other participating institutions may commence the research upon submitting their ethics review approval or letters of acceptance thereof.
Article 35. Within six months after the expiration of the validity period, the collaborating parties that have obtained a license or completed a filing shall jointly submit to MOST a report on the collaborative research, covering research objectives, implementation, the use and disposition of resources, Chinese-party participation, the allocation of results, ethical review, and other matters.
Section 3 Advance Reporting for Cross-Border Provision and Open-Access Use
Article 36. Providing or making available human genetic resource information to overseas organizations, individuals, or institutions established or actually controlled by them shall be reported to MOST in advance, and an information backup shall be submitted. The report shall include the purpose and intended use, basic information on the recipient, and a risk assessment of the impact on resource protection.
Where information is provided to the foreign party during the implementation of an approved international scientific research collaboration project, and the use of such information by both parties has already been agreed upon in the international agreement, a separate advance report is not required.
Article 37. Where the provision of human genetic resource information to overseas organizations, individuals, or institutions established or actually controlled by them may affect China’s public health, national security, or public interest of society, a security review organized by MOST shall be passed. Categories subject to such security review include:
(1) information on important genetic families;
(2) information on human genetic resources specific to particular regions;
(3) whole-exome or whole-genome sequencing data for 500 or more subjects; and
(4) other circumstances stipulated by MOST.
Article 38. MOST shall, in conjunction with relevant departments, formulate security review rules and organize expert security assessments. The export of human genetic resources shall comply with the laws and regulations of the State on export controls.
Section 4 Procedures for Administrative Licensing, Filing, and Advance Reporting
Article 39. Where application materials are complete and meet the formal requirements, MOST shall accept the application and issue an acceptance receipt. Where materials are incomplete or fail to meet formal requirements, MOST shall notify the applicant in writing of all items requiring supplementation or correction within five working days.
Article 40. MOST shall establish an expert pool and an expert management system. Review experts shall be selected by random draw to conduct technical reviews of applications and security assessments of information proposed for cross-border provision subject to security review. Experts shall generally participate via online means; meetings or on-site inspections may be used when necessary.
Article 41. MOST shall make a licensing decision within twenty working days from the date of acceptance. Where a decision cannot be made in a timely manner, the period may be extended by ten working days with approval, and the applicant shall be notified in writing.
Article 42. The time spent on hearings, inspections, tests, quarantine, identification, and technical reviews shall not be counted toward the licensing period, but the applicant shall be notified in writing thereof.
Article 43. MOST shall notify the applicant in writing of the licensing decision and send a copy to the provincial-level science and technology administrative department in the applicant’s location. Decisions granting a license shall be published on MOST’s website; decisions refusing a license shall state the reasons and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative lawsuit.
Article 44. After obtaining a collection license, an application for modification shall be submitted where significant changes occur in the participating entities, purpose, or protocol of the collection activities.
Article 45. After obtaining a preservation license, an application for modification shall be submitted where significant changes occur in the purpose or protocol of the preservation activities.
Article 46. After obtaining an international collaboration license, an application for modification shall be submitted where significant changes occur in the type, quantity, or intended use of resources covered by the research purpose, content, or protocol, or where the sponsor or lead institution changes.
Article 47. After obtaining a license, where changes involve only a quantity change not exceeding 10% of the approved amount, a change of participating entities, a change in the legal person’s name, or a change that does not affect the type, quantity, or intended use of resources or falls within the approved scope, no modification application is required; however, a written notice shall be submitted.
Article 48. MOST shall review modification applications and decide whether to approve them. The procedures shall follow the rules applicable to license applications.
Article 49. Where an applicant withdraws an application in writing before a licensing decision is made, MOST shall terminate the review.
Article 50. MOST may, upon the request of a person with an interest in the matter or on its own initiative, revoke a license in circumstances including: abuse of authority, exceeding authority, procedural violation, or granting a license to an applicant that does not meet the qualifications or conditions, or other circumstances in which revocation is permitted by law. A license obtained by fraud, bribery, or other improper means shall be revoked. A license shall not be revoked where doing so would cause significant harm to the public interest.
Article 51. Applications to file international collaborative clinical trials shall first obtain the clinical trial approval letter or filing registration materials issued by the drug regulatory authority.
Article 52. An application to file a clinical trial shall include: basic information on the collaborating parties; the type, quantity, and intended use of the resources to be utilized; the research protocol; the ethics review approval from the lead institution; and other supporting materials.
Article 53. After completing a clinical trial filing, where significant changes occur in the type, quantity, or intended use of resources, or in the collaborating parties or research protocol, a modification of the filing shall be processed. Where the protocol or content changes do not involve changes to the resources, no modification is required, but a written notice shall be submitted before the change.
Article 54. After an advance report has been submitted, where the intended use or recipient changes, a modification report shall be submitted before the change.
Article 55. Where a licensee needs to extend the validity period, an application shall be submitted no fewer than thirty working days before expiration. MOST shall make a decision before expiration; if no decision is made before expiration, the extension shall be deemed approved. The same applies to filers seeking to extend a filing; if the extension has not been completed by the expiration date, it shall be deemed completed.
Chapter V Supervision and Inspection
Article 56. MOST is responsible for national supervision and inspection; provincial-level science and technology administrative departments are responsible for supervision and inspection within their respective jurisdictions. Inspection matters include:
(1) the fulfillment of responsibilities and implementation of rules and regulations by entities engaged in collection, preservation, utilization, or cross-border provision;
(2) the collection, preservation, and utilization under approved projects, as well as the export of materials, cross-border provision, and post-export use;
(3) the disposition of remaining materials, as well as intellectual property rights and interest-sharing arrangements;
(4) the authenticity of filed matters; and
(5) other matters requiring supervision and inspection.
Article 57. MOST and provincial-level science and technology administrative departments shall draw up annual supervision and inspection plans, and shall implement risk management for human genetic resources. Plans shall specify the matters, methods, frequency, and the types and proportion of projects to be sampled for inspection.
Article 58. Entities that have been penalized for violations within the past three years, that have not corrected identified management risks, or that have been included in a credit blacklist shall be subject to increased inspection frequency and incorporated into the routine inspection plan. Entities that have improved their management practices and have not committed further violations may be subject to reduced inspection frequency.
Article 59. For other entities, MOST and provincial-level science and technology administrative departments may, within the scope of such entities’ resource activities, randomly determine the matters and personnel subject to inspection, and carry out supervision and inspection accordingly.
Article 60. Targeted supervision and inspections may be deployed where serious violations are discovered, where temporary or emergency tasks arise, or where problems are identified through complaints, referrals, or data monitoring.
Article 61. Information from routine supervision and inspections shall be promptly recorded and aggregated, and inspection measures shall be improved accordingly.
Article 62. Where there is reason to believe that a violation of the Regulation may be occurring, an administrative regulatory interview (约谈) may be conducted with the legal representative, principal responsible person, or other relevant personnel of the entity concerned.
Article 63. Where a potential violation is discovered, an investigation shall be initiated. Measures that may be taken as necessary include: recording, copying, photographing, and videotaping; sealing up or detaining items; and inspecting, testing, quarantining, or identifying items.
Article 64. Administrative compulsory measures shall be carried out in accordance with the procedures set out in the Administrative Compulsion Law of the People’s Republic of China.
Article 65. The taking and lifting of administrative compulsory measures shall be approved by the head of the authority. A written decision on sealing up or detaining items and a detailed list thereof shall be prepared and delivered on the spot. In urgent situations, measures may be taken before approval is obtained; the approval procedures and service of documents shall be completed within twenty-four hours.
Chapter VI Administrative Penalties
Article 66. MOST and provincial-level science and technology administrative departments shall exercise administrative penalty discretion in a standardized manner, taking comprehensive account of the facts, nature, circumstances, and social harm of the violation, and determining the type and magnitude of the penalty within the scope prescribed by the Regulation, to ensure that the penalty is proportionate to the offense. MOST shall separately formulate and publish administrative penalty discretion benchmarks.
Article 67. Before a proposed penalty is imposed, the party concerned shall be notified in writing of the proposed penalty, the underlying facts, the reasons, and the legal basis, and shall be informed of the right to make statements and defenses, and the right to request a hearing. Where a hearing is required, the right to a hearing shall be notified. The party shall submit its statements or defense in writing within five working days of service of the notice; failure to do so within the time limit shall be deemed a waiver. The penalty shall not be aggravated on account of the party’s exercise of the right to make statements, offer defenses, or request a hearing.
Article 68. Where any of the following penalties are proposed, a hearing shall be organized if requested by the party concerned:
(1) a fine of RMB 1,000,000 or more imposed on a legal person or other organization, or a fine of RMB 100,000 or more imposed on a citizen;
(2) confiscation of illegal gains of RMB 3,000,000 or more from a legal person or other organization, or RMB 300,000 or more from a citizen;
(3) prohibition from engaging in related activities for one year or more;
(4) refusal to accept license applications for two years or more;
(5) revocation of a license already obtained; or
(6) other circumstances provided for by law.
Article 69. Before a penalty decision is made, the case-handling unit shall submit the proposed decision and related materials to the legal review unit for review. No decision may be made without review or where the review has not been passed. Cases involving only a warning are exempt from legal review.
Article 70. After a penalty decision is made, it shall be served on the party concerned within seven working days in accordance with the law.
Article 71. A penalty decision shall be made within ninety days from the date of case initiation. Where the case is complex and a decision cannot be made within that period, the period may be extended by ninety days with approval. Where the case is especially complex and a decision still cannot be made after the extension, the period may be further extended, but not by more than sixty days, upon collective deliberation by the authority’s responsible persons. Time spent on hearings, public announcements, testing, and similar procedures shall not be counted toward the case-handling period.
Article 72. Illegal gains referred to in Articles 36, 39, 41, 42, and 43 of the Regulation shall be calculated as total revenues minus reasonable and appropriate expenditures; where they are difficult to calculate, the value of the resources or the amount of funds invested shall be used as the illegal-gains figure.
Article 73. During supervision and inspection or investigation of violations, where a relevant entity is found to lack adequate storage conditions, MOST shall organize the transfer of the resources to an entity with adequate conditions for temporary storage.
Article 74. Where a provincial-level science and technology administrative department imposes a penalty in accordance with law, it shall submit a copy of the case-handling report and the penalty decision to MOST within fifteen working days from the date the penalty decision is made.
Article 75. MOST has the right to supervise administrative penalties imposed by provincial-level science and technology administrative departments, and shall order the correction of unlawful or improper conduct in accordance with law.
Chapter VII Supplementary Provisions
Article 76. With respect to time-period provisions, periods expressed in “working days” exclude statutory holidays; periods not so specified are calendar days.
Article 77. The expressions “above” (以上) and “not exceeding” (不超过) include the referenced number; the expressions “greater than” (大于) and “less than” (不足) exclude the referenced number.
Article 78. These Implementing Rules shall come into force on July 1, 2023.