Author(s)

Huang Lu ¹

Affiliation(s)

¹ JunHe LLP Shanghai Office, Shanghai, 200041, China

Corresponding Author

Huang Lu

ABSTRACT

This paper primarily explores the common issues faced by Chinese pharmaceutical companies in the regulatory compliance of human genetic resources (HGR). The revision of the "Regulations on the Administration of Human Genetic Resources" and the change of the competent authority have presented new challenges for pharmaceutical companies in international cooperation and the provision of HGR information to foreign entities. This paper analyzes the identification of foreign entities, the necessity and pathway selection for the declaration of international cooperative clinical trials, the safety review requirements for the provision of HGR information to foreign entities, and the compliance obligations for personal information crossing borders. It also provides practical experience sharing through case analysis and points out potential future changes in regulatory compliance requirements.

KEYWORDS

Pharmaceutical companies, HGR regulation, Personal information crossing borders

CITE THIS PAPER

Huang Lu. Compliance by Pharmaceutical Enterprises of Human Genetic Resources Supervision—Observations of Some Common Issues. Science of Law Journal (2024) Vol. 3: 51-57. DOI: http://dx.doi.org/DOI: 10.23977/law.2024.030707.

REFERENCES

[1] Gao XD, Jiao YL. Ethical selection of informed consent models in the study and utilization of human genetic resources. Chin Med Ethics, 2021, 34(4):408-413, 432.
[2] Su Y, He R, Wang Y, et al. Strengthening the protection and utilization of human genetic resources in China. Chin J Clin Lab Manage, 2017, 5(1):9-11.
[3] Liang P, Xu Y, Zhang X, et al. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein Cell 2015; 6: 363–372.

Sponsors, Associates, and Links

---

• Journal of Language Testing & Assessment
  
  
• Information and Knowledge Management
  
  
• Military and Armament Science
  
  
• Media and Communication Research
  
  
• Journal of Human Movement Science
  
  
• Art and Performance Letters
  
  
• Lecture Notes on History
  
  
• Lecture Notes on Language and Literature
  
  
• Philosophy Journal
  
  
• Journal of Political Science Research
  
  
• Journal of Sociology and Ethnology
  
  
• Advances in Broadcasting