The benefits and risks of the drugs is the embodiment of the contradiction between the two sides,how to trade-off is significant.REMS is established in legislative form of risk management tools by the U.S.government designed to ensure that the benefits outweighed the risks of drug use.The alosetron case is a success of REMS regulatory,review this case in-depth can understand that how REMS to help the drugs to be used properly and safely,release of public disorder.The analysis of Alosetron REMS and its implementation of basic in this paper provide ideas for the drug regulatory <<