International Journal of Pharmaceutical Medicine

, Volume 20, Issue 6, pp 367–372

Human Subjects Protections in Clinical Drug Trials in China

A Focus on the Institute Level


  • Jiaqi Xu
    • Department of Drug Safety and InspectionState Food and Drug Administration
  • Benfu Li
    • Chinese Medical Ethics Association
  • Qiang Ma
    • Chinese Medical Ethics Association
    • Shanghai Health Bureau
  • Haitao Heidi Liu
    • Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP)
    • Medical Ethics ProgramPeking University Health Science Center
Special Section on Medicines Development in China Focus on China

DOI: 10.2165/00124363-200620060-00005

Cite this article as:
Xu, J., Li, B., Ma, Q. et al. Int J Pharm Med (2006) 20: 367. doi:10.2165/00124363-200620060-00005


With the increasing number of clinical trials being undertaken in China over the last few years, stakeholders in human subjects protections (HSP) are facing many new challenges; currently, these challenges in HSP are largely taken up by the ethical review committees and study investigators. This article identifies a number of issues with the present system and suggests ways to resolve these issues at the institutional level. Though the Chinese government has developed a basic regulatory framework for HSP, further work still needs to be done.

It is imperative that China develops a robust and reliable HSP system at the institutional level as drug studies are increasingly being undertaken in mainland China.

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© Adis Data Information BV 2006