Management discussion of laws and regulations on human genetic resources in China: a scoping review.

BACKGROUND

The governance of human genetic resources (HGRs) in China has evolved quickly, driven by national security concerns and the rapid expansion of the biotechnology sector. This review examines the resulting legal and policy framework, with a focus on cross-border data transfers and the management of informed consent.

METHODS

Employing a comprehensive search strategy integrated with bibliometric analysis, this study synthesized theoretical and methodological developments in Chinese HGRs management. Literature searches spanned publications across PubMed, Web of Science, CNKI, Wanfang database, official government websites, and Google.

RESULTS

China’s HGRs management has evolved from principle-based legislation to specific administrative regulations. Informed consent has become stricter, with HGRs data classified as sensitive personal information requiring separate consent and the right to withdraw. This orientation enables strict oversight but also defines the limits within which informed consent can function. The number of international cooperation projects declined after 2023 due to refined regulatory classifications and multi-departmental collaboration. HGRs cross-border require a security review and filing by the National Health Commission, with sensitive data subject to additional assessment by the Cyberspace Administration. In contrast, general cross-border flows are primarily managed through security assessments or standard contract filings, with the negative list mechanism and risk-level exemptions being piloted in free trade zones.

CONCLUSION

National security and data sovereignty remain central to China’s HGR governance, shaping strict oversight while limiting the practical reach of informed consent. Cross-border data sharing continues to face challenges, including regulatory discrepancies, privacy risks that extend beyond de-identification, and technical inconsistencies in data formats and annotation standards. Future progress requires enhanced transparency regarding data usage, improved technical interoperability aligned with domestic security requirements, and stronger international coordination through bilateral agreements.