Abstract: Objective Through introducing and analyzing regulatory history and evaluation experiences for post-marketing drugs, to provide valuable reference to reevaluation of post-marketing drugs in China. Methods By introducing Drug Efficacy Study Implementation (DESI) which performed in 1960s in US, and interpreting Marketed Unapproved Drugs-Compliance Policy Guide, the evaluation of post-marketing drugs and regulatory experiences obtained in US has been discussed following the updates of regulations and the improvement of cognitive level. Results and Conclusion Experiences obtained from DESI and actions taken for marketed unapproved drugs by FDA in US could provide valuable reference to reevaluation of post-marketing drugs in China.

Key words: post-marketing drug, evaluation, regulation, United States