Introduction

China’s Human Genetic Resources Law framework regulates the collection, preservation, utilization, and cross-border provision of human genetic materials and genetic information. Its primary objectives are to protect public health, individual privacy, national security, and the public interest while enabling legitimate scientific research, biotechnology innovation, and medical development.

The framework is principally governed by the Regulations on the Administration of Human Genetic Resources, originally promulgated in 2019 and revised in March 2024, together with the Biosecurity Law of the People’s Republic of China, the Personal Information Protection Law, and the implementing rules for human genetic resources. The revised regulations took effect on 1 May 2024. Administrative responsibility for human genetic resources was transferred from the Ministry of Science and Technology to the National Health Commission from that date. <Cite refs={["turn487741search1","turn487741search5"]}/>

Meaning and Scope of Human Genetic Resources

Human genetic resources comprise two principal categories. First, human genetic resource materials include organs, tissues, cells, and other biological materials containing human genetic material. Second, human genetic resource information includes genetic data and other information generated through the analysis of such materials.

The framework applies to relevant activities involving Chinese human genetic resources, including scientific investigations, population-genetics research, genomic sequencing, biotechnology development, and certain international clinical research collaborations. Its application depends on the type of material or information, the activities undertaken, the parties involved, and whether information or physical samples are provided abroad.

The implementing rules distinguish genetic information from certain other categories of data, including clinical, imaging, protein, and metabolic data. However, such data may remain subject to other privacy, health-data, cybersecurity, or research regulations.

Principal Legislative Framework

1. Regulations on the Administration of Human Genetic Resources

The 2019 Regulations, revised in 2024, constitute the central administrative framework. They establish rules for collecting, preserving, utilizing, and providing human genetic resources outside China. They also address ethical review, informed consent, institutional responsibilities, international cooperation, and administrative penalties.

Article 7 restricts foreign organizations, individuals, and institutions established or actually controlled by them from collecting or preserving Chinese human genetic resources within China or providing those resources abroad. Foreign participation in eligible research must therefore comply with the applicable cooperation and authorization requirements.

Article 9 requires compliance with ethical principles, protection of providers’ privacy, prior informed consent, and safeguarding of their lawful rights and interests. Article 10 prohibits the sale of human genetic resources, while allowing reasonable cost payments associated with lawful scientific research.

These provisions seek to balance scientific development with individual rights and public-interest safeguards. <Cite refs={["turn487741search0","turn487741search2"]}/>

2. Biosecurity Law of China

The Biosecurity Law, effective from 15 April 2021 and revised in 2024, establishes broader safeguards for biological research and biological resources. It addresses risks associated with biotechnology, biological materials, and activities potentially affecting public health or national security.

Human genetic resources form part of this broader biosecurity framework. Institutions conducting relevant research must assess both the specific human-genetic-resources requirements and any additional biosafety, research, data-protection, or institutional obligations applicable to their activities.

3. Implementing Rules of 2023

The Implementing Rules, effective from 1 July 2023, provide operational detail concerning approvals, filings, supervision, and administrative enforcement. They clarify procedures for international research cooperation, genetic-data provision, and security reviews.

The rules are particularly important for multinational pharmaceutical companies, universities, hospitals, and research institutions working with Chinese genetic datasets. Compliance must be assessed against the amended regulations and the current responsibilities of the National Health Commission.Collection, Preservation and Informed Consent

The regulations distinguish ordinary research activities from activities requiring specific administrative authorization. Collection of genetic resources from important genetic families, designated regions, or specified categories and quantities may require approval. Preservation of Chinese human genetic resources is also subject to the applicable regulatory requirements.

Article 12 of the original regulatory framework establishes detailed informed-consent requirements for collection, including disclosure of the research purpose, intended use, potential health implications, privacy protections, and the participant’s right to participate voluntarily and withdraw without conditions. Ethical review must be conducted in accordance with applicable requirements.

Consent is not a substitute for administrative authorization. Researchers must separately determine whether their project requires institutional ethics approval, regulatory approval, filing, or additional permissions for subsequent data use.

International Research Cooperation and Cross-Border Data

Foreign institutions generally cannot independently collect or preserve Chinese human genetic resources within China. Eligible international research must comply with the applicable cooperation requirements and involve appropriate Chinese institutions.

The revised framework distinguishes international scientific research cooperation from certain international clinical trials. For qualifying clinical trials conducted to obtain marketing authorization for drugs or medical devices in China, where genetic materials are not exported and the regulatory conditions are satisfied, prior approval may be replaced by a filing procedure. This exemption should not be assumed to apply to every clinical study.

Providing genetic information abroad also requires a separate assessment. Depending on the information, applicable filing, domestic backup, and security-review requirements may apply. Genetic information concerning important genetic families, designated regions, or large-scale genomic datasets may attract additional scrutiny.

Institutions must therefore assess physical sample transfers, remote access to databases, overseas analysis, cloud storage, and disclosure to foreign collaborators separately. The absence of physical sample export does not automatically eliminate every regulatory obligation. <Cite refs={["turn487741search3","turn487741search6","turn199875search1"]}/>

Privacy, Bioethics and Personal Information

China’s Personal Information Protection Law and Civil Code provide additional protections relevant to genetic research. Article 1009 of the Civil Code requires activities involving human genes and human embryos to comply with laws, administrative regulations, and relevant state provisions and not endanger human health, violate ethics, or harm the public interest.

Genetic information can reveal sensitive characteristics of individuals and, in some circumstances, relatives or wider populations. Research institutions should establish appropriate access controls, data minimization, secure storage, retention policies, and procedures for handling participant withdrawal and unauthorised disclosure.

Ethical governance must also address the commercial use of research findings, the scope of participant consent, and whether subsequent research remains consistent with the original authorization and applicable law.