Special Section on Medicines Development in China Focus on China

International Journal of Pharmaceutical Medicine

, Volume 20, Issue 6, pp 367-372

First online:

Human Subjects Protections in Clinical Drug Trials in China

A Focus on the Institute Level
  • Jiaqi XuAffiliated withDepartment of Drug Safety and Inspection, State Food and Drug Administration
  • , Benfu LiAffiliated withChinese Medical Ethics Association
  • , Qiang MaAffiliated withChinese Medical Ethics AssociationShanghai Health Bureau
  • , Haitao Heidi LiuAffiliated withForum for Ethical Review Committees in Asia and the Western Pacific (FERCAP)
  • , Yali CongAffiliated withMedical Ethics Program, Peking University Health Science Center Email author 

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Abstract

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.