Abstract: Drug quality supervision which involves many stakeholders is a complex system problem. This paper applies WSR system approach to analyze the Wuli, Shili and Renli factors in drug safety supervision. WSR framework for drug safety supervision is proposed. Different from the traditional descriptive analysis toward Renli in the past literatures, this paper uses evolutionary game theory to model the behavior and interest motivation of participants in drug safety supervision, and provides suggestions for the design of drug quality and safety supervision mechanism. Besides, Changsheng biological vaccine incident is employed to illustrate the important significance of Renli in drug quality supervision. The results show that the drug regulatory scheme based on WSR needs to consider the public opinions, regulatory strength and accountability strength; improving the management mode of existing regulatory agencies can avoid the opportunism of regulatory agencies; the public may make the drug quality supervision fall into a state of shock by expressing their demands unreasonably.

Key words: drug safety regulation, WSR system approach, evolutionary game theory, Renli