To effectively implement the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China" and ensure that all provisions are properly put into practice, thereby further enhancing the efficiency of human genetic resource management in China, the Ministry of Science and Technology has drafted the "Detailed Rules for Implementing the Regulations on the Administration of Human Genetic Resources (Draft for Public Comment)." These rules are now open for public consultation. We welcome feedback from everyone and encourage you to share your comments via the following channels and methods:

1. Please send your comments via email to sfs_swyyc@most.cn, with the subject line "Draft Implementation Measures for Feedback."

2. Please send your comments by mail to: Department of Social Development, Science and Technology Division, Ministry of Science and Technology, No. 15 Yijianfu Road, Haidian District, Beijing, China (Postal Code: 100862). Kindly mark the envelope with "Solicitation of Comments on Implementation Rules."

3. Send your comments via fax to: 010-58881471.

Feedback is welcome until April 21, 2022.

Department of Social Development Science and Technology, Ministry of Science and Technology

Chapter 1 General Provisions

Article 1 [Purpose and Legal Basis] To effectively protect and appropriately utilize China's human genetic resources, safeguard public health, national security, and the broader public interest, these Implementation Rules are formulated based on laws and administrative regulations such as the "Biosecurity Law of the People's Republic of China," the "Data Security Law of the People's Republic of China," the "Administrative Licensing Law of the People's Republic of China," the "Administrative Penalty Law of the People's Republic of China," the "Law of the People's Republic of China on Scientific and Technological Progress," the "Law of the People's Republic of China on Promoting the Transformation of Scientific and Technological Achievements," and the "Regulations on the Administration of Human Genetic Resources of the People's Republic of China" (hereinafter referred to as the "Regulations").

Article 2 [Scope of Application] The collection, preservation, utilization, and external provision of China's human genetic resources shall comply with these Implementing Rules.

For the purposes of clinical diagnosis and treatment, blood and organ supply services, investigation and prevention of illegal activities and crimes, doping control, funeral services, and other related activities, the collection and preservation of human materials such as organs, tissues, and cells—and the conduct of associated operations—shall be carried out in accordance with relevant laws and administrative regulations.

Human genetic resources include human genetic resource materials and human genetic resource information. Human genetic resource materials refer to genetic materials such as organs, tissues, and cells that contain the human genome, genes, and other hereditary substances.

Human genetic resource information refers to genetic and genomic data, as well as other information generated from the use of human genetic resource materials.

Article 3 [Central Management System] The Ministry of Science and Technology (hereinafter referred to as "MOST") is responsible for the nationwide management tasks related to the approval, supervision, and enforcement of penalties concerning human genetic resources.

Relevant institutions can be entrusted by the Ministry of Science and Technology to undertake specific support tasks such as license acceptance, professional assistance, and oversight and management.

Article 4 [Local Governance System] The science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of Xinjiang Production and Construction Corps, are responsible for managing human genetic resources within their respective administrative areas.

(1) Daily management and oversight of human genetic resources;

(II) Undertake, at the request of the Ministry of Science and Technology, the organization of human genetic resource surveys and related activities within this region;

(III) Responsible for investigating and penalizing illegal cases within the scope of assigned authority, and conducting investigations into such cases in this region as commissioned by the Ministry of Science and Technology;

(4) Implementing matters related to human genetic resources as commissioned by the Ministry of Science and Technology.

Article 5 [Strengthening Law Enforcement Capabilities] The Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, should strengthen their oversight capabilities for human genetic resources. They should ensure adequate staffing of law enforcement inspectors and, where necessary, hire auxiliary enforcement personnel to carry out regular inspections and monitoring of human genetic resource activities within their respective administrative or management areas, thereby fulfilling their legal responsibilities in the supervision and management of these resources.

Article 6 [Expert Advisory Mechanism] The Ministry of Science and Technology should appoint experts from fields such as life sciences and technology, medicine, public health, ethics, law, and information security to form an expert advisory committee. This committee will provide policy advice and technical support for the management of human genetic resources, while also implementing an expert review mechanism aligned with administrative licensing procedures.

Article 7 [Optimizing Services] The Ministry of Science and Technology supports the responsible use of human genetic resources to advance scientific research, foster the biopharmaceutical industry, and enhance diagnostic and treatment technologies. It also emphasizes strengthening the management and oversight of human genetic resources, continuously promoting reforms in the administrative licensing review system for these resources, optimizing review processes, boosting efficiency, advancing standardization of reviews, ensuring transparent information dissemination, and ultimately elevating the overall quality of management and service delivery.

Chapter 2: General Requirements

Article 8 [Ethics Review Requirements] The collection, preservation, use, and external provision of China's human genetic resources must undergo ethical review. Specific requirements shall follow relevant regulations issued by the national health administrative department regarding ethical review of life science and medical research involving human subjects.

Article 9 [Requirements for Rights Protection] The collection, preservation, utilization, and external provision of China's human genetic resources must respect the privacy rights of the resource providers, obtain informed consent in advance, ensure the health of the providers, and safeguard their legitimate rights and interests.

Article 10 [Technical Compliance] Collecting, preserving, utilizing, and providing China's human genetic resources to external parties,

Researchers should adhere to the relevant requirements and technical standards of scientific research activities, including but not limited to standards, guidelines, and procedures.

Article 11 [Eligibility Requirements] Within the territory of China, the collection, preservation, and external provision of China's human genetic resources must be conducted exclusively by Chinese research institutions, universities, medical organizations, and enterprises (hereinafter referred to as "Chinese Entities"). Foreign organizations, individuals, and any entities established or effectively controlled by them (hereinafter referred to as "Foreign Entities") are prohibited from collecting or preserving China's human genetic resources within China, nor may they provide such resources to entities outside China.

Article 12 [Foreign Entity] The "foreign entity" refers to organizations located outside China, as well as institutions established or effectively controlled by foreign organizations or individuals.

The aforementioned actual control includes the following scenarios:

(1) Foreign organizations or individuals hold, directly or indirectly, more than 50 percent of the shares, equity interests, voting rights, property shares, or other similar rights in the institution;

The rights to use, transfer, and share the benefits of scientific achievements—such as publications, data, standards, and process methodologies—resulting from international collaborative research conducted using China's human genetic resources shall be determined through a cooperative agreement between the parties involved. If the agreement does not specify these arrangements or if the terms are unclear, both parties retain the right to use the成果; however, any transfer of these成果 to third parties must be approved by both sides. Any revenue generated will be shared based on the respective contributions of each party—provided that the extent of their contributions cannot be clearly identified, in which case the benefits will be divided equally between the collaborating partners.

(III) Foreign organizations or individuals, through agreements or other arrangements, are capable of exerting significant influence over the institution’s major decisions, management practices, and other critical matters;

(IV) Other circumstances recognized by the Ministry of Science and Technology.

Article 13 [Responsibilities of Relevant Entities] Units collecting, preserving, utilizing, and providing China's human genetic resources to external parties must strengthen their management systems, review the objectives and research plans of scientific studies involving these resources, and ensure the lawful use of human genetic materials.

Article 14 [Formal Agreement on International Cooperation] When conducting international scientific research using China's human genetic resources, the collaborating parties should, in accordance with the principles of equality and mutual benefit, honesty and trustworthiness, joint participation, and shared outcomes, legally sign a cooperation agreement that clearly and specifically outlines all relevant matters.

Article 15 [Cooperative Data Sharing and Backup] When conducting international collaborative scientific research using China's human genetic resources, it is essential to ensure that Chinese institutions and their researchers are actively and substantially involved throughout the entire process. All records and data generated during the research must be fully accessible to the Chinese partner, and backup copies should also be provided to the Chinese institution.

Article 16 [International Cooperation on Patent Sharing] When applying for patents on research outcomes resulting from international scientific collaborations that utilize China's human genetic resources, the application must be jointly submitted by both collaborating parties, and the patent rights will be jointly owned by both partners.

Article 17 [Sharing of International Cooperation Benefits] The rights to use, transfer, and share the benefits of scientific achievements—such as publications, data, standards, and process methodologies—resulting from international collaborative research conducted using China's human genetic resources shall be determined through a cooperative agreement between the parties involved. If the agreement does not specify these arrangements or if the terms are unclear, both parties retain the right to use the成果; however, any transfer of these成果 to third parties must be approved by both sides. Any revenue generated will be shared based on the respective contributions of each party—provided that the extent of their contributions cannot be clearly identified, in which case the benefits will be divided equally between the collaborating partners.

Article 18 [ Expert Responsibilities 】Experts are responsible for providing professional opinions and recommendations on technical reviews, safety assessments, and other related matters. Based on technical needs, the Ministry of Science and Technology organizes experts to conduct technical reviews of applications submitted in accordance with the Regulations—specifically those involving the collection and preservation of China’s human genetic resources, international collaborative scientific research projects, and the export, mailing, or transportation of human genetic resource materials out of China. The review findings serve as a key reference for making approval decisions. Additionally, for human genetic resource information that could potentially impact public health, national security, or broader societal interests in China, the Ministry of Science and Technology must arrange for expert-led safety reviews before such information is shared externally.

The Ministry of Science and Technology, in its daily management, supervision, inspection, and survey registration of human genetic resources, organizes experts to provide decision-making advice and technical support as needed.

Article 19 [Information Technology Development] The Ministry of Science and Technology should strengthen the construction of its human genetic resource management information system, enabling applicants to conveniently use the internet for submitting applications, registering, applying for administrative permits, and filing records. This will facilitate real-time, dynamic online management, ensuring that human genetic resource information is fully documented, traceable, and easily accessible.

Article 20 [Construction of Preservation Infrastructure and Databases] The Ministry of Science and Technology, together with relevant departments of the State Council, as well as science and technology departments (commissions or bureaus) from provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, is promoting research institutions, universities, medical organizations, and enterprises to carry out preservation activities in accordance with laws and regulations. They are also advancing the establishment of standardized, well-organized basic platforms for human genetic resource preservation, along with robust big-data infrastructure, and ensuring these resources are openly accessible—subject to national guidelines—to eligible research institutions, universities, medical facilities, and businesses.

Article 21 [Government Services] The Ministry of Science and Technology should formulate and promptly release approval guidelines and model documents regarding the collection, preservation, utilization, and external provision of China's human genetic resources, while strengthening guidance for applicants on handling related licensing, filing, and other procedures.

Article 22 [Training Management] The Ministry of Science and Technology regularly organizes training sessions for personnel involved in scientific research activities related to the collection, preservation, and utilization of human genetic resources, as well as for managers from relevant departments, aiming to enhance their awareness of laws and regulations and improve their management and service capabilities.

Article 23 [Communication and Exchange] Units involved in the collection, preservation, utilization, and external provision of China's human genetic resources may communicate and exchange information with the Biological Center on critical issues—whether during the pre-approval application phase, throughout the implementation of approved activities, or at stages such as relevant information backup and filing. The Biological Center may also organize meetings or discussions with applicants as needed for its operational requirements.

Chapter 3: Investigation, Registration, and Data Backup

Article 24 [Investigating Authority] The Ministry of Science and Technology regularly organizes a nationwide survey of human genetic resources. The science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, are responsible for the actual implementation of the human genetic resource survey within their respective administrative areas.

Article 25 [Frequency of Investigations] The National Survey of Human Genetic Resources is conducted every five years, and can be organized as needed based on actual requirements.

Article 26 [Investigation Requirements] The Ministry of Science and Technology has organized experts from relevant fields to develop a national survey plan for human genetic resources. The science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, are required to promptly submit and consolidate the survey data collected.

Article 27 [Management of the Catalog of Important Human Genetic Resources] Based on the nationwide survey of human genetic resources, the Ministry of Science and Technology is organizing research on key genetic families and human genetic resources from specific regions, gradually establishing a comprehensive inventory list that will be updated and refined as needed.

Article 28 [Registration of Important Human Genetic Resources] The Ministry of Science and Technology is responsible for the registration of important genetic families and human genetic resources from specific regions, organizes the development of guidelines for application and registration, and establishes an information service platform to manage these processes.

Article 29 [Proactive Declaration of Important Human Genetic Resources] Chinese research institutions, universities, medical organizations, and enterprises that discover important genetic pedigrees and human genetic resource information from specific regions should promptly register this data through the designated registration and management information service platform.

Article 30 [Data Backup] When providing or making human genetic resource information available for use to organizations or individuals outside China, as well as to institutions they establish or effectively control, it is mandatory to submit an information backup to the agency designated by the Ministry of Science and Technology and to register this with the same ministry.

Chapter 4: Administrative Licensing, Filing, and Safety Review

Section 1: Scope and Requirements for Administrative Licensing Collection

Article 31 [Scope of Collection] The administrative license for the collection of human genetic resources applies to activities involving the collection of such resources within the territory of China, including the following situations:

(1) Important Genetic Families: Refers to blood-related groups that either suffer from genetic disorders or possess hereditary traits—such as unique physical characteristics—spanning three or more generations (including the third generation). However, the collection of human genetic resources related to common multifactorial diseases like hypertension and diabetes is excluded from this definition.

(II) Human Genetic Resources from Specific Regions. These refer to genetic resources derived from populations that have lived for extended periods in isolated or unique environments, exhibiting distinct physical traits or adaptive characteristics related to their physiological features. Importantly, the designation of "specific regions" is not based on whether they are home to ethnic minority communities.

(III) Collection activities involving 3,000 or more participants in large-scale population studies. Large-scale population studies include, but are not limited to, cohort studies, cross-sectional studies, clinical research, and anthropometric studies. However, collection activities associated with clinical studies aimed at obtaining marketing authorization for relevant pharmaceuticals and medical devices in China are excluded from this category.

Article 32 [Conditions for Collection Permits] Applications to conduct the collection of human genetic resources in China must meet the following conditions:

(1) Possess legal personality;

(II) The purpose of data collection is clear and lawful;

(III) The data collection plan is reasonable;

(IV) Undergo ethical review;

(5) Possesses a department and management system responsible for the administration of human genetic resources;

(6) Possessing premises, facilities, equipment, and personnel that are suitable for the collection activities.

Article 33 [Requirements for Reporting and Data Collection] The collection of China's human genetic resources must be carried out by Chinese entities with legal status, and the process must be reviewed by an ethics committee that has been registered with the relevant administrative authorities.

Section 2: Scope and Requirements for Preservation Administrative Licensing

Article 34 [Scope of Preservation] The permit for the preservation of human genetic resources applies to activities conducted within China that involve the preservation of such resources and serve as a foundational platform for scientific research.

Preservation activities refer to the practice of storing legally obtained human genetic resources under appropriate environmental conditions to ensure their quality and safety for future scientific research—this excludes temporary storage conducted solely for educational purposes or as part of laboratory testing, provided such storage complies with legal and regulatory requirements or is specifically outlined in clinical study protocols.

Article 35 [Conditions for Preservation Authorization] Applications to carry out the preservation of human genetic resources in China must meet the following conditions:

(1) Possess legal personality;

(II) The purpose of preservation is clear and lawful;

(III) The preservation plan is reasonable;

(IV) The source of the human genetic resources intended for preservation is legally compliant;

(5) Undergo ethical review;

(6) A department responsible for managing human genetic resources and a system in place for their preservation and storage;

(7) Possessing facilities, infrastructure, equipment, and personnel that meet the national technical standards and requirements for the preservation of human genetic resources.

Article 36 [Preservation Requirements] The preservation of China's human genetic resources must be carried out by Chinese entities with legal status, which have also undergone ethical review by an ethics committee registered with the relevant administrative authorities.

Article 37 [Exemption from Preservation License] Items that meet the requirements for a preservation permit application do not require a separate request for an acquisition permit. The preservation institution should strengthen its management to ensure that human genetic resources are collected in strict accordance with laws and regulations.

Article 38 [Annual Report] Human genetic resource preservation institutions must, in accordance with Article 15 of the Regulations, submit an annual report to the Ministry of Science and Technology by March 31 each year, detailing their activities related to the preservation of human genetic resources during the previous year. A copy of this report should also be sent to the science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as to the Science and Technology Bureau of the Xinjiang Production and Construction Corps. The Ministry of Science and Technology, together with the provincial, regional, and municipal science and technology departments (committees or bureaus), will conduct inspections of these preservation activities every five years. The annual report must include the following information:

(1) Status of human genetic resources in preservation;

(II) Information on the sources and uses of human genetic resources;

(III) Implementation of management systems related to the preservation of human genetic resources;

(4) The maintenance and any changes made to the facilities, equipment, and premises used by this unit for the preservation of human genetic resources;

(5) Our unit is responsible for maintaining records of staff changes.

Section 3: Scope and Requirements for Administrative Licensing and Filing in International Cooperation

Article 39 [Scope of International Cooperation] Administrative licensing and filing for international collaborative scientific research involving human genetic resources apply to projects conducted by Chinese institutions together with foreign entities, utilizing China's human genetic resources.

Article 40 [Conditions for International Cooperation Licenses] Applications for administrative permits to conduct international scientific research using China's human genetic resources must meet the following conditions:

(1) Does not pose any harm to public health, national security, or the social public interest in our country;

(II) Both parties involved possess the foundation and capability to carry out the relevant work;

(III) The purpose and content of the collaborative research are clear, legal, and appropriately scoped within a reasonable timeframe;

(4) The collaborative research plan is reasonable;

(5) The proposed sources of human genetic resources are legally obtained, and the types and quantities match the scope of the research.

(6) Through ethical reviews conducted in the respective home countries (or regions) of both collaborating parties;

After review by the ethics committee of the Chinese partner organization, it was determined that applying for an international cooperation permit or filing for human genetic resources does not involve significant ethical concerns. Additionally, if the foreign party’s ethics review truly cannot be provided, a waiver of their ethics review may be granted.

For multi-center clinical trials, the leading center can submit an application for administrative approval or file a备案 (record-filing) after obtaining ethical review approval.

Participating medical institutions can initiate international collaborative clinical trials by submitting the approval or consent documents from their own institutional ethics review board, along with a commitment letter signed and stamped by their organization, to the Ministry of Science and Technology after the leading institution has obtained the necessary administrative license or备案 (filing).

Providing or making human genetic resource information available for use to foreign organizations, individuals, or entities established or effectively controlled by them requires submission of a备案 (record-filing) to the Ministry of Science and Technology. The filing materials must include the following: To obtain marketing authorization for relevant drugs and medical devices in China, collaborating with Chinese entities to conduct international clinical trials at clinical institutions—using China’s human genetic resources without involving the export of such materials—requires the following: All parties involved in the collaboration, along with details about the types, quantities, and intended uses of the human genetic resources to be utilized, must be filed with the Ministry of Science and Technology. However, no approval is required in this case.

(1) The collection, testing, analysis, and handling of remaining samples—activities involving human genetic resources—are conducted within clinical institutions;

(II) The human genetic resources involved are collected within clinical institutions and subsequently tested, analyzed, and processed for remaining samples by domestic entities designated in the clinical trial protocols for approved drug and medical device marketing authorization trials.

A clinical institution refers to medical institutions, disease prevention and control organizations, and other entities that have been registered with the relevant authorities and are authorized to conduct clinical research.

For clinical studies seeking marketing authorization for relevant drugs and medical devices in China, if they involve exploratory research components, a separate application must be submitted in accordance with the administrative approval requirements for international collaborative scientific research.

Article 42 [International Cooperation Licensing and Filing Procedures] International cooperation administrative permits and filings must be jointly applied for or processed by both the Chinese and foreign entities involved. In the application materials, all cooperating parties must commit to ensuring the authenticity, accuracy, and completeness of the information provided.

For multi-center clinical studies, administrative license applications or filings must not be split.

Article 43 [International Cooperation Licensing and Filing Procedures] For multi-center clinical trials, the leading center can submit an application for administrative approval or file a备案 (record-filing) after obtaining ethical review approval.

Participating medical institutions can initiate international collaborative clinical trials by submitting the approval or consent documents from their own institutional ethics review board, along with a commitment letter signed and stamped by their organization, to the Ministry of Science and Technology after the leading institution has obtained the necessary administrative license or备案 (filing).

Article 44 [Report on International Cooperation] When conducting international collaborative scientific research using China's human genetic resources, the collaborating parties must jointly submit a report on the status of the cooperative research to the Ministry of Science and Technology within 6 months after the expiration date of cooperation specified in the international collaboration agreement. The report on the status of the collaborative research should include the following information:

(1) Changes in research objectives, content, and other related matters;

(II) Status of Research Protocol Implementation;

(III) Status of Research Completion;

(IV) The Status of Human Genetic Resource Usage in China;

(5) The status of handling China's human genetic resources;

(6) Examine the status of data recording, storage, and usage;

(7) The involvement of both collaborating parties in the research, with a focus on the Chinese partner’s full-process and substantive participation;

(8) Research Findings;

(9) Changes in the Ownership and Distribution of Research Outcomes;

(10) Study cases involving ethical review.

Section 4: Scope and Requirements for Exporting and Providing Administrative Licenses and Filing to Foreign Entities

Article 45 [Conditions for Exit Permit] When conducting international collaborative scientific research using China's human genetic resources, or in other special circumstances requiring the export—whether by shipment, mail, or personal carriage—of materials derived from China's human genetic resources, the following conditions must be met, and approval from the Ministry of Science and Technology must be obtained.

(1) Does not pose any harm to public health, national security, or the social public interest in our country;

(II) Possess legal personality;

(III) There is a clearly defined overseas partner and a reasonable purpose for the outbound travel;

(IV) Human genetic resource materials are collected legally or originate from legitimate preservation institutions;

(5) Pass the ethical review.

Article 46 [Application for Exit Permit] Conducting international collaborative scientific research using China's human genetic resources requires the shipment, mailing, or export of these resources. Such requests can be submitted either as a separate application or included alongside the proposed plan for international collaboration in the main application for scientific research—both options will then be reviewed and approved jointly by the Ministry of Science and Technology.

Chinese units in China will handle customs clearance for the export of human genetic resource materials by presenting the Ministry of Science and Technology’s Certificate for Export of Human Genetic Resource Materials.

Article 47 [Submission of Filing Content to External Parties] Providing or making human genetic resource information available for use to foreign organizations, individuals, or entities established or effectively controlled by them requires submission of a备案 (record-filing) to the Ministry of Science and Technology. The filing materials must include the following:

(1) The purpose and intended use for providing or making available China's human genetic resources, including genes and genomic information, to external parties;

(II) Providing or enabling access to human genetic resources—genes and genomic information—to foreign entities;

(III) Information received by the receiving entity;

(IV) Assessment of Potential Risks to the Protection of China's Human Genetic Resources.

Article 48 [Security Review System] Providing or making available human genetic resource information to foreign organizations, individuals, or entities they establish or effectively control—when such actions could potentially impact public health, national security, or broader societal interests in China—must first undergo a security review organized by the Ministry of Science and Technology.

Article 49 [Scope of Security Review] Situations requiring a security review include the external provision or open access to the following information:

(1) Information on human genetic resources from key family pedigrees;

(II) Human genetic resource information from specific regions;

(III) Exome sequencing and genome sequencing data resources for populations of 500 or more individuals;

(IV) Other information that could potentially affect public health, national security, and the broader public interest in our country.

Article 50 [Requirements for Security Review] The Ministry of Science and Technology, together with relevant departments, has formulated principles for security reviews, assembled experts from related fields to conduct security review assessments, and will make decisions based on the experts' evaluation findings.

Section 5: Workflow for Licensing and Filing

Article 51 [Method of Declaration] The Ministry of Science and Technology should establish a public and unified information system platform for administrative licensing, filing, and safety reviews related to human genetic resources management, making it easier for applicants to submit their applications.

Article 52 [License Application and Acceptance] The applicant submits the application materials online and delivers the physically printed documents to the Administrative Licensing Acceptance Window of the Ministry of Science and Technology (hereafter referred to as the "Acceptance Window"). If the application materials are complete and meet the required formal standards, the Acceptance Window will formally accept the application, issue an acceptance receipt, and provide a written document stamped with the official seal of the administrative agency and dated accordingly.

If the application materials submitted by the applicant are incomplete or do not conform to the legally prescribed format, the applicant must be informed within 5 days of all the required corrections in a single notice.

If an administrative license application is not accepted, the authority must explain the reasons for rejection within 5 days and provide a written document stamped with the official seal of the administrative agency and dated accordingly.

Article 53 [Establishment of an Expert Database] The Ministry of Science and Technology should establish an expert database, formulate key criteria for technology assessment and safety reviews, and develop mechanisms for managing, deploying, and phasing out experts, all in accordance with the needs of these review processes.

Article 54 [Technical Review/Safety Assessment] The Ministry of Science and Technology organizes expert reviews for all accepted applications. For cases falling within the scope of security assessments, a separate security review must be conducted. The Ministry will randomly select evaluation experts from its pool of qualified specialists. Both technical reviews and security assessments are typically carried out via online platforms; however, if necessary, alternative methods such as meetings or on-site inspections may also be employed.

Article 55 [License Decision] The Ministry of Science and Technology reviews the evaluation opinions and makes a decision to approve or reject them.

Article 56 [Term of License] The Ministry of Science and Technology shall, within 20 days from the date of acceptance, review applications submitted under the Regulations for the collection, preservation of China’s human genetic resources, conducting international collaborative scientific research, and transporting, mailing, or carrying such resources out of the country—and issue a decision to approve or reject each application. In cases where an application is denied, the Ministry must provide a detailed explanation for its decision. If, due to special circumstances, a timely approval decision cannot be made, the review period may be extended by up to 10 additional days, subject to approval by the ministry’s senior leadership.

Article 57 [Exemption from Licensing Time Limits] The following periods will not be counted toward the relevant work deadlines:

(1) Time spent by the applicant on providing additional materials and verifying relevant declaration information as required;

(II) Time spent on organizing technical reviews, safety assessments, and similar activities;

(III) The time occupied during the suspension of the review and approval process as stipulated by laws and regulations;

(4) The time required to verify any violations of the Regulations involving the applying entity.

(5) Time spent consulting with relevant departments.

Article 58 [Service of Process] After making the approval decision, the Ministry of Science and Technology will notify the applicant and send a copy to the science and technology departments (committees or bureaus) of the applicant’s respective province, autonomous region, or municipality directly under the central government, as well as to the Science and Technology Bureau of the Xinjiang Production and Construction Corps. If the administrative license is approved in accordance with the law, the approval result will be publicly posted on the Ministry of Science and Technology’s website for public access. Conversely, if the decision is to deny the administrative license as required by law, the Ministry must provide a detailed explanation of the reasons and inform the applicant of their right to file an administrative reconsideration or initiate an administrative lawsuit as permitted by law.

Article 59 [Amendment of Collection Permit] When conducting activities involving the collection of China's human genetic resources, any changes to the participating institutions, the duration of the collection activities, or the collection plan must be submitted to the Ministry of Science and Technology for approval.

Article 60 [Amendment of Preservation License] When changes occur in the preservation activities of China's human genetic resources—such as alterations to the preservation period or the preservation plan—organizations must apply to the Ministry of Science and Technology for approval of these modifications.

Article 61 [Significant Changes to International Cooperation Licenses] When conducting international collaborative scientific research using China's human genetic resources, the following situations require applying to the Ministry of Science and Technology for a permit amendment:

(1) Changes in the sponsor, leading institution, contract research organization, or third-party laboratory;

(II) When the research objective has changed;

(III) When the research content has been changed;

(IV) When significant matters such as the cooperation period are subject to changes.

A request for significant changes must be submitted one month prior to the implementation of the change.

Article 62: [Non-Material Changes to International Cooperation Licenses] During international collaborative scientific research utilizing China's human genetic resources, the following situations do not require an application for a permit change—but relevant materials must still be submitted to the Ministry of Science and Technology for explanation and record-keeping:

(1) The study protocol remains unchanged; any modifications involve changes that do not exceed 10% of the originally approved sample size.

(II) Participating units other than those listed in Article 61, Paragraph 1 above, as well as cases where the legal entity names of the collaborating parties have changed;

(III) For changes to the research plan that do not involve alterations in the type, quantity, or intended use of human genetic resources, or if the revised content remains within the scope of the previously approved parameters,

Article 63 [License Application/Withdrawal] If the applicant requests to withdraw the administrative license application, the Ministry of Science and Technology may terminate the review or revoke the administrative license.

If the applicant requests to withdraw a valid administrative license, the Ministry of Science and Technology has the authority to decide whether to approve the withdrawal.

Article 64 [Filing and Reporting] Administrative filing for clinical studies aimed at obtaining marketing authorization for relevant drugs and medical devices in China can be initiated immediately after receiving the clinical trial approval or filing from the drug regulatory authority.

For any significant changes—such as alterations in the purpose of externally providing or making publicly available human genetic resource information—that have already been filed, the collaborating party must promptly terminate the filing record, upload a summary report, and submit a revised备案 (record-filing) application tailored to the specifics of the change. The filing documents include the following:

(1) The registered clinical research institutions involved, the types, quantities, and intended uses of human genetic resources utilized in the study;

(II) Research Proposal;

(III) Ethical Review Approval from the Leading Organization.

Article 66 [Changes to International Cooperation Filing] For internationally collaborative projects that have already been registered, any significant changes—such as alterations in the types, quantities, or intended uses of human genetic resources, or even changes solely related to the duration of the collaboration—must be promptly reported for registration updates by the collaborating parties.

Research activities that do not involve changes in the types, quantities, or intended uses of human genetic resources—or those involving only changes to the duration of collaboration—do not require re-registration. However, a timely submission of a change description is still necessary before the modified activity begins.

Article 67 [Data Filing Amendments] For any significant changes—such as alterations in the purpose of externally providing or making publicly available human genetic resource information—that have already been filed, the collaborating party must promptly terminate the filing record, upload a summary report, and submit a revised备案 (record-filing) application based on the specifics of the change.

Data and information generated through international collaboration should be used by the collaborating parties as agreed upon in the international cooperation agreement, and there is no need to separately file or register data backups.

Article 68: [Strengthening Oversight of Integrity Risks] During the licensing and filing processes, the competent authorities should establish and continuously improve measures to prevent integrity risks, strengthen supervision, and ensure that situations such as abusing power for personal gain or shirking responsibilities are effectively avoided.

Section 6: Rapid Approval Mechanism

Article 69 [Fast Approval] The Ministry of Science and Technology has established a rapid review and approval mechanism. In response to emergencies such as sudden public health events, administrative approvals involving human genetic resources required for emergency responses can now be expedited.

Article 70 [Requirements for Expedited Approval] Rapid approval for emergency incidents will follow the special/specific regulations of relevant departments.

Article 71 [Expedited Approval Process and Time Limits] For administrative license applications subject to the fast-track approval process, the Ministry of Science and Technology will organize accelerated and synchronized efforts in application acceptance, review, and approval, guided by the principles of unified command, high efficiency, and scientific decision-making. Specific details—including the circumstances, procedures, timelines, and requirements—of the fast-track process will be outlined separately by the Ministry of Science and Technology.

Chapter 5: Supervision and Inspection

Article 72 [Matters for Supervision and Inspection] The Ministry of Science and Technology is responsible for nationwide supervision and inspection of human genetic resource activities. The science and technology departments (committees or bureaus) of each province, autonomous region, and municipality directly under the central government—and the Science and Technology Bureau of the Xinjiang Production and Construction Corps—are tasked with conducting these inspections within their respective administrative areas. The Ministry of Science and Technology, along with the provincial, autonomous region, and municipal-level science and technology departments (committees or bureaus), as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall carry out regular supervision and inspection of relevant entities to ensure compliance with the "Regulations" and other applicable laws, regulations, and rules governing human genetic resource activities. Should inspection personnel fail to fulfill their duties, abuse their authority, neglect their responsibilities, or engage in corruption and malpractice, they will be disciplined according to law. If their actions constitute a crime, criminal liability will be pursued in accordance with the law.

(1) The implementation of primary responsibilities by organizations involved in the collection, preservation, utilization, and external provision of human genetic resources, as well as their establishment, improvement, and enforcement of relevant rules and regulations.

(II) The status of collection, preservation, and actual use of human genetic resources by the entities approved for human genetic resource projects;

(III) Details regarding the outbound transfer, external provision, open access, and post-outbound usage of samples or data; the disposition of remaining samples; as well as arrangements for sharing intellectual property rights and outcomes achieved.

(IV) The authenticity and other relevant details of the human genetic resource filing matters;

(5) Other matters that the Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps deem necessary for supervision and inspection.

Article 73 [Supervision and Inspection Plan] The Ministry of Science and Technology, along with the science and technology departments (commissions or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, should develop annual supervision and inspection plans to implement human genetic resource risk management.

The annual supervision and inspection plan should include inspection items, inspection methods, inspection frequency, as well as the types and sampling proportions of randomly selected projects.

Article 74 [Key Supervision and Inspection] Units that have received administrative penalties from science and technology regulatory authorities within the past three years, those with unresolved risks in human genetic resource management that have not been promptly addressed, and those listed on the dishonesty punishment list should face more frequent supervision and inspection. These entities should be included in the annual routine inspection plan, with comprehensive inspections carried out across the board. Meanwhile, organizations with robust management systems, standardized practices, and no history of violations over an extended period may see their inspection frequency reduced.

Article 75 [Random Supervisory Inspections] For entities other than those specified in Article 73 of these Implementing Rules, the Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, may randomly determine inspection and supervision projects within the scope of activities conducted by human genetic resource entities, and may also randomly assign inspectors to carry out cross-checks.

Article 76 [Special Supervision and Inspection] When serious violations of the law occur, or in response to temporary, emergency tasks—as well as specific issues identified through complaints, reports, referrals, or data monitoring—the Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, may deploy special supervision and inspection efforts.

Article 77 [Collection of Supervision and Inspection Information] The Ministry of Science and Technology, along with the science and technology departments (commissions or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, should promptly record and compile daily supervision and inspection information related to human genetic resource activities, and further refine their routine oversight measures.

Article 78 [Accountability Talks] When the entities subject to supervision and inspection may be at risk of violating relevant provisions of the Regulations, the Ministry of Science and Technology—or the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps—may conduct administrative talks with their legal representatives, key executives, and other senior officials.

Article 79 [Measures for Preserving Evidence] The entity subject to supervision and inspection may be found in violation of relevant provisions of the Regulations. In cases where evidence could be lost or become difficult to obtain later, the Ministry of Science and Technology, or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, may take the following measures:

(1) Take timely measures such as recording, copying, photographing, and video recording, as appropriate;

(II) Taking administrative enforcement measures such as seizure and detention in accordance with the law;

(III) Items requiring testing, inspection, or appraisal shall be submitted for such processes.

Article 80 [Approval of Administrative Compulsory Measures] The Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, must obtain approval from the head of their respective agencies before implementing or lifting administrative enforcement measures.

Article 81 [Procedures for Administrative Compulsory Measures] The Ministry of Science and Technology, or the science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall carry out administrative enforcement measures in accordance with the procedures stipulated in the "Administrative Enforcement Law of the People's Republic of China," and must deliver the decision letter and inventory list for the administrative enforcement measures on the spot.

Article 82 [Handling of Suspected Violations] If the suspected illegal act falls under the circumstances outlined in Articles 39 and 43 of the Regulations and, as a result, qualifies for administrative penalties within the jurisdiction of the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps, these departments/bureaus should promptly initiate an administrative penalty investigation.

Chapter 6: Administrative Penalties

Section 1: General Provisions

Article 83 [ The entity subject to administrative penalties 】The Ministry of Science and Technology, along with the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall impose administrative penalties on natural persons, legal entities, or other organizations for violations of laws and regulations governing human genetic resources, in accordance with their statutory powers and procedures. These detailed rules apply unless otherwise specified by law or administrative regulations.

Article 84 [Types of Administrative Penalties] Types of administrative penalties for illegal acts involving human genetic resources:

(1) Warning;

(II) Fines;

(III) Confiscate illegally collected or preserved human genetic resources and any illegal gains;

(IV) Prohibition of engaging in activities involving the collection, preservation, utilization, or external provision of China's human genetic resources;

(5) Other administrative penalties prescribed by laws and administrative regulations.

Section 2: Jurisdiction

Article 85 [Functional Jurisdiction and Territorial Jurisdiction] Administrative penalty cases involving violations of human genetic resource regulations are under the jurisdiction of either the Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps—specifically, whichever entity is located where the violation occurred.

Article 86 [Transfer of Jurisdiction and Designated Jurisdiction] The Ministry of Science and Technology, or the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall accept cases involving illegal activities related to human genetic resources. If an agency finds that a case falls outside its own jurisdiction, it must promptly forward it to the competent science and technology administrative department or another relevant authority.

If the science and technology departments (commissions or bureaus) of provinces, autonomous regions, and municipalities directly under the central government—and the Science and Technology Bureau of the Xinjiang Production and Construction Corps—have any objections regarding jurisdiction, they should submit a request to the Ministry of Science and Technology for designated jurisdiction.

Article 87 [Coordination Between Criminal Enforcement and Prosecution] If violations of human genetic resource regulations constitute a crime, the Ministry of Science and Technology or the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall refer the case to the judicial authorities. In cases referred by the judicial authorities where criminal liability is not required by law or where criminal punishment is waived but administrative penalties are still warranted, jurisdiction shall rest with the Ministry of Science and Technology or the relevant provincial, autonomous region, or municipality-level science and technology departments (commissions or bureaus), including the Xinjiang Production and Construction Corps' Science and Technology Bureau.

Article 88 [Transfer of Jurisdiction] The Ministry of Science and Technology can directly investigate cases under the jurisdiction of the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps. Alternatively, it may transfer cases within its own jurisdiction to these same provincial, regional, and municipal authorities for handling. Meanwhile, the science and technology departments (commissions or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, along with the Science and Technology Bureau of the Xinjiang Production and Construction Corps, have the authority to report particularly significant or complex cases to the Ministry of Science and Technology for oversight.

Article 89 [ Administrative Penalty Delegation 】The Ministry of Science and Technology may, as needed, delegate the implementation of administrative penalties to the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as to the Science and Technology Bureau of the Xinjiang Production and Construction Corps, within the scope of its statutory authority. Within the delegated authority, these provincial, regional, and municipal science and technology departments—and the Xinjiang Production and Construction Corps Science and Technology Bureau—shall carry out administrative penalties in the name of the Ministry of Science and Technology, and shall not further delegate this responsibility to any other organizations or individuals.

The Ministry of Science and Technology should oversee the provincial, autonomous region, and municipality science and technology departments (committees or bureaus), as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, in their implementation of administrative penalties, and bear legal responsibility for the consequences of these enforcement actions.

Article 90 [Supervision of Administrative Penalties] The Ministry of Science and Technology has the authority to correct or revoke unlawful or inappropriate administrative penalties imposed by the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps.

Section 3: Case Filing

Article 91 [Case Filing] If the Ministry of Science and Technology, or the science and technology departments (commissions or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps discover that individuals, legal entities, or other organizations are suspected of engaging in illegal activities—activities that legally warrant administrative penalties and fall under their jurisdiction—they must initiate a case accordingly.

Article 92 [Handling of Suspected Violations] For those cases where there is reasonable grounds to believe that the conditions for collecting and preserving human genetic resources are not met, the Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall, in accordance with the law, order corrective action within a specified time limit and, within 15 days, take the following measures:

(1) Seize and impound relevant equipment, facilities, and human genetic resources in accordance with the law. When seizing or impounding human genetic resources, these resources must be transferred temporarily to a qualified organization equipped with proper preservation conditions for safekeeping.

(II) Impose administrative penalties in accordance with the law;

(3) Upon verification, if the relevant entities have implemented corrective measures and now meet the applicable collection and preservation requirements, the seizure or detention shall be lifted. When carrying out a seizure or detention, a decision letter specifying the action, along with a detailed inventory of the seized or detained items, must be issued on the spot. However, if failing to act promptly could jeopardize the investigation or if there is an imminent risk of harm—such as potential loss or destruction of human genetic resources—the authorities may first proceed with the seizure or detention and subsequently complete the formal decision letter within 24 hours, delivering it to the party concerned.

Article 93 [Change in Deadline for Corrective Action and Follow-up Review] Relevant authorities ordered to make corrections within a specified timeframe must complete the required changes by the deadline. If, due to objective reasons, completion within the set period is impossible, the entity must submit a written request for an extension—along with ongoing corrective actions—no later than 10 days before the original deadline expires. The Ministry of Science and Technology, or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall respond in writing within 5 days of receiving the request, indicating whether the extension has been approved. If the entity submits a request for a re-inspection or if the original correction deadline arrives without action, the Ministry of Science and Technology, or the relevant provincial, regional, or municipal science and technology authority, must conduct a re-inspection within 10 days from the date of the request or the expiration of the deadline. The re-inspection report, including the findings and recommendations, must be signed by both the inspected entity and the Ministry’s inspection team members, then officially filed for record. Failure to implement the required corrections by the new deadline—or if the corrections are deemed inadequate—may result in administrative penalties imposed by the Ministry of Science and Technology in accordance with the law.

Article 94 [Recusal of Law Enforcement Officers] For cases that have already been officially filed, the case-filing approver shall designate two or more law enforcement officers from the Ministry of Science and Technology or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps—provided these officers are duly authorized to enforce the law—to conduct the investigation.

Law enforcement officers handling the case must recuse themselves if any of the following circumstances apply:

(1) I am a party to this case or a close relative of a party;

(II) The individual or their immediate family members have a vested interest in this case;

(III) Having other vested interests with the individual that could potentially affect the fair handling of the case.

The recusal of case-handling law enforcement officers from the Ministry of Science and Technology or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall be decided by the head of the respective agency. Until a recusal decision is made, the officers assigned to handle the case—whether from the Ministry of Science and Technology or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Xinjiang Production and Construction Corps—must not unilaterally halt their investigation into the case.

Article 95 [Investigation Procedures] Inquiries or inspections must be documented in a written record. The record should include details such as the time, location, and specifics of the questioning or inspection, and must be signed or stamped by the person being questioned, the inspected entity, and the enforcement officers. If the person being questioned or the inspected entity requests corrections, these requests must be accommodated. If the individual being questioned or the entity refuses to sign or affix their stamp, the enforcement officers should clearly note the reason on the record and sign it themselves.

Article 96 [Collecting and Obtaining Evidence] Law enforcement officers should collect and obtain original documents relevant to the case as evidence. If it is genuinely difficult to retrieve the original documents, copies may be made instead, provided they are signed by the person who issued the evidence or stamped with the official seal of the issuing entity.

Article 97 [Methods of Collecting Evidence] Law enforcement officers may use sampling methods when collecting evidence. If the evidence is at risk of being lost or may become difficult to obtain later, with approval from the head of this agency, they can first register and preserve it—though a decision on how to proceed must be made within 7 days.

(1) If the facts of the violation are established and confiscation is legally required, an administrative penalty decision shall be made to impose confiscation; if detention or sealing is legally mandated, the item shall be detained or sealed accordingly.

(II) If the alleged violation does not hold true, or if confiscation, detention, or seizure is not legally warranted, the registration-based preservation shall be lifted.

Article 98 [Inspection and Examination Procedures] When law enforcement officers conduct inspections and examinations of items or locations related to a case, they must notify the parties involved to be present, prepare an inspection record, and have the parties verify its accuracy before signing or affixing their seal. If the parties refuse to attend, officers may invite other individuals present as witnesses and note this in the inspection record. Alternatively, they can document the condition of the relevant items and locations through audio or video recordings before proceeding with the inspection and examination.

Section 4: Seeking Input and Hearings

Article 99 [Prior Notice of Administrative Penalties] Before making an administrative penalty decision, the Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall deliver a Notice of Intent to Impose Administrative Penalty to the party concerned, specifying the following details:

(1) The facts, reasons, and legal grounds for the proposed administrative penalty;

(II) Proposed Administrative Penalty Decision;

(III) The parties shall, in accordance with the law, have the right to make statements and present their defenses;

(4) Parties who meet the conditions stipulated by laws and regulations have the right to request a hearing.

Article 100 [Rights of Parties to a Hearing, Statement, and Defense] If the parties involved request a hearing, they must submit a written request to the Ministry of Science and Technology or to the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or to the Science and Technology Bureau of the Xinjiang Production and Construction Corps within 5 days of receiving the notice. If the parties fail to submit a written hearing request by the deadline, they will be deemed to have waived their right to a hearing.

If the parties do not request a hearing, they may submit a written statement and defense to the Ministry of Science and Technology or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps within 15 days after receiving the notice. The Ministry of Science and Technology, or the relevant provincial, regional, or municipal science and technology authorities, will review the facts, reasons, and evidence presented by the parties. If the facts, reasons, and evidence provided by the parties are found to be valid, they must be accepted.

The Ministry of Science and Technology, or the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall not impose heavier penalties simply because the parties involved have made statements or presented their defenses.

If the Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps make adjustments to the key facts, reasons, legal grounds, or proposed penalty decisions outlined in a previously delivered Notice of Administrative Penalty, they must re-serve the Notice to the party involved—unless the adjustments, based on the party’s statements and rebuttals, result in changes that are favorable to the party.

Article 101 [Right of Parties to Review Evidence] After receiving the notice of impending administrative penalty, the party concerned may apply to review the evidence related to their own administrative penalty case, except for content involving state secrets, others' trade secrets, and personal privacy.

Article 102 [Scope of Hearings] The Ministry of Science and Technology, or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, plan to impose one or more of the following administrative penalties on the parties involved in accordance with the law. If the party concerned requests a hearing, a hearing must be organized: (1) Confiscation of illegal gains exceeding 1 million yuan; (2) Imposition of fines exceeding 5 million yuan; (3) Prohibition from engaging in activities related to the collection, preservation, utilization, or external provision of China’s human genetic resources; (4) Other circumstances where a hearing is required as stipulated by laws, regulations, and rules.

Article 103 [Organization of Hearings] After receiving a request for a hearing from the parties involved, the Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall conduct a review. For requests that meet the requirements, they must promptly organize a hearing and notify the parties in writing at least 7 days prior to the hearing, specifying details such as the time and location. At the same time, the case investigators will also be informed.

The parties must attend the hearing on time. If a party fails to attend the hearing as scheduled, it will be deemed to have waived its right to a hearing.

Article 104 [Methods for Parties to Participate in Hearings] If the parties entrust an agent to attend the hearing, they must submit a power of attorney to the Ministry of Science and Technology, as well as to the science and technology departments (committees or bureaus) of provinces, autonomous regions, and municipalities directly under the central government, and to the Science and Technology Bureau of the Xinjiang Production and Construction Corps, prior to the hearing. The power of attorney must clearly specify the scope and extent of the authorization.

Article 105 [Rights and Obligations of Parties Regarding Hearings] The rights and obligations of the parties during the hearing:

(1) Has the right to present statements and defenses regarding the facts of the case, the applicable laws, and relevant circumstances;

(II) Has the right to challenge the evidence presented by investigators and submit new evidence;

(III) State the facts of the case truthfully and answer questions;

(4) Adhere to hearing discipline and follow the instructions of the hearing chairperson.

Article 106 [Hearing Procedures] The hearing shall proceed according to the following procedures:

(1) Before the hearing begins, the clerk shall verify whether the parties to the case, their representatives, and the case investigators—among other hearing participants—are present, and then announce the rules of conduct for the hearing.

(II) The hearing chairperson verifies the identities of all participants, announces the list of hearing officers, secretaries, and case investigators attending the hearing, informs the participants of their rights and obligations during the hearing, and asks whether any party involved in the case requests recusal.

(III) The hearing chairperson announces the start of the hearing and states the case details;

(4) The case investigators present the specific facts of the party's violation, along with supporting evidence and recommendations for administrative penalties, backed by relevant legal grounds.

(5) The parties and their representatives present statements, defenses, and challenge evidence, as well as submit evidence to support their own arguments;

(6) With the permission of the hearing chairperson, both the parties and their representatives, as well as the case investigators, may cross-examine each other regarding the facts of the case and may also question witnesses and expert witnesses.

(7) Questions from the moderator and hearing officers;

(8) The parties make supplementary statements;

(9) The hearing chairperson announces the conclusion of the hearing.

Article 107 [Powers of the Hearing Chairperson] The hearing chairperson has the authority during the hearing to intervene against any behavior by participants that violates the rules of the hearing room; for those who refuse to comply despite being warned, the chairperson may order them to leave the hearing venue.

Article 108 [Submission of Hearing Materials] At the conclusion of the hearing, the parties involved in the case and their representatives should submit their rebuttal materials along with relevant evidence to the hearing panel.

Article 109 [Hearing Record] The clerk shall record the hearing proceedings in minutes. The hearing minutes must be submitted to the parties involved in the case, their representatives, the investigators of this case, witnesses, and other relevant personnel for verification. Once confirmed as accurate, all parties must sign or affix their seals to the minutes. If any inaccuracies are identified, the parties may request additional information or corrections. If no errors are found but the parties still refuse to sign or seal the minutes, the clerk shall clearly note the situation in the hearing records.

Article 110 [Hearing Deliberation] After the hearing concludes, the hearing panel should deliberate. The case investigators and case reviewers may participate in the deliberation and provide their input. A record of the case deliberation must be prepared and signed by the hearing panel members.

Article 111: [Hearing Does Not Affect the Parties' Legal Recourse Against the Penalty Decision] The holding of the hearing does not affect the parties' rights to apply for administrative reconsideration or file an administrative lawsuit after the administrative penalty decision has been made.

Section 5: Review and Decision

Article 112 [Circumstances to Be Considered When Exercising Discretionary Powers] The Ministry of Science and Technology, along with the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, must exercise their administrative penalty powers in accordance with the legislative intent, while comprehensively considering the following circumstances:

(1) The harm and impact caused by the illegal act;

(II) Whether the parties were at fault and the extent of their fault;

(III) The specific methods or means of the illegal act;

(4) The specific target harmed by the illegal act;

(5) Whether the party is committing the offense for the first time;

(6) The parties' attitude toward correcting the illegal behavior, the corrective measures they have taken, and their effectiveness.

For similar or comparable violations with equivalent levels of social harm, the type and severity of administrative penalties should be proportionate.

Article 113 [Legal Review] After the investigation of a case is concluded, law enforcement officers from the Ministry of Science and Technology or the science and technology departments (commissions, bureaus) of provinces, autonomous regions, municipalities directly under the central government, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall complete the Case Handling Approval Form. This form, along with all relevant evidence materials, must then be submitted to the head of their respective department for approval. Before the head of the agency makes a decision on administrative penalties, the case-handling department is required to forward the documents to the legal affairs department for legal review.

Article 114 [Service of the Penalty Decision Document] After the administrative penalty decision is issued, the Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, and municipalities directly under the central government—and the Science and Technology Bureau of the Xinjiang Production and Construction Corps—shall, within 7 days, serve the administrative penalty decision on the party concerned or other legally designated recipients in accordance with the relevant provisions of the Civil Procedure Law.

(1) Delivery must be accompanied by a delivery receipt, which the recipient shall sign or affix a seal to, clearly indicating the date of receipt.

(2) Service shall be effected directly to the person to be served. If the person to be served is a citizen who is not present, the document should be handed over to a cohabiting adult family member for signature, with the relationship to the recipient clearly noted in the remarks section of the delivery receipt for the administrative penalty decision.

(III) If the addressee is a corporation or other organization, delivery shall be signed for by the corporation’s legal representative, the principal officer of the other organization, or the person designated by the corporation or organization to receive documents.

(4) If the recipient designates a third party to receive documents on their behalf, the designated person shall sign for receipt and clearly indicate that they are acting under the recipient's authorization.

(5) If direct delivery proves genuinely difficult, documents may be sent by registered mail. Alternatively, they can be entrusted to the local Ministry of Science and Technology or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps for delivery on your behalf. Once the Ministry of Science and Technology or the provincial, regional, municipal, or corps-level science and technology authorities receive the documents, they must immediately forward them to the intended recipient for signature and acknowledgment.

(6) If the party concerned or their cohabiting adult family member refuses to sign for receipt, the deliverer shall invite representatives from a relevant grassroots organization or other appropriate individuals to witness the process. The circumstances must be clearly noted on the delivery receipt of the administrative penalty decision, including the reason for refusal and the date. Both the deliverer and the witness(es) shall then sign or affix their seals to confirm the event. Once the document is left at the party’s receiving department or residence, it will be deemed as properly served.

(7) If the recipient’s whereabouts are unknown, or if delivery cannot be made through the methods outlined above, delivery may be effected by public notice. Such notice shall be deemed to have been served 60 days after its publication. When delivering other administrative penalty enforcement documents, the Ministry of Science and Technology, or the science and technology departments (committees, bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps, shall follow the procedures specified in the preceding paragraph.

Article 115 [Time Limit for Issuing Penalty Decisions] Administrative penalty cases must be concluded with an administrative penalty decision within 60 days from the date of case initiation. If completion is not possible due to objective reasons, the head of the Ministry of Science and Technology or the science and technology department (commission or bureau) of the province, autonomous region, municipality directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps may approve an extension, provided that the extension does not exceed 90 days. In exceptional circumstances requiring a further extension, approval from the Ministry of Science and Technology is necessary, allowing the deadline to be extended up to 180 days.

Article 116 [Combined Penalties] If the relevant entities and personnel violate different laws, administrative regulations, or departmental rules, resulting in two or more acts of misconduct that each warrant administrative penalties, the Ministry of Science and Technology—or the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps—shall apply the appropriate provisions separately, assess penalties individually for each offense, and then impose a combined penalty.

Article 117 [Method for Calculating Illegal Gains] The illegal proceeds from unlawfully collecting or preserving human genetic resources, illegally using such resources in international collaborations, or improperly providing them to foreign entities shall be determined based either on the value of the collected genetic resources or the amount of funding invested in those resources.

Section 6: Implementation

Article 118 [ [Item Destruction] Except for items that must be destroyed according to law, facilities and equipment seized or detained shall be auctioned off to offset fines, in accordance with legal provisions or relevant national regulations.

Items shall be destroyed in accordance with relevant national regulations; if no specific regulations exist, the destruction must be approved by the head of the Ministry of Science and Technology or the science and technology department (commission or bureau) of the province, autonomous region, municipality directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps. The process must be supervised by at least two law enforcement officers from the Ministry of Science and Technology or the respective provincial, regional, or municipal science and technology authorities, and a detailed destruction record must be prepared. A comprehensive inventory of the items to be disposed of must also be created.

Article 119 [Filing] If the science and technology departments (committees or bureaus) of provinces, autonomous regions, municipalities directly under the central government, or the Science and Technology Bureau of the Xinjiang Production and Construction Corps impose administrative penalties in accordance with the law, they must report such decisions to the Ministry of Science and Technology for record within 10 days from the date the penalty decision is made.

Article 120 [Filing] After the administrative penalty has been fully enforced, the case files must be compiled and archived according to relevant regulations. Once the case files are officially filed and archived, no organization or individual may arbitrarily add, remove, alter, or destroy the file materials.

Chapter 7: Supplementary Provisions

Article 121 [Definition of Dates] The time limits specified in these detailed implementation rules refer to working days, excluding statutory holidays.

Article 122 [Effective Date] These Implementing Rules shall come into effect on [Date], 2022.