人类经历了多次药害事件后,许多国家均相继建立了各种不同的上市后药品监察体系(Postmar-keting Surveillance System),其目的都是保证药品的安全性和有效性,如英国的黄卡系统、绿卡系统,美国食品药品管理局(FDA)倡导的医生自愿报告制度(Spontaneous Physician Reporting System)、联动记录系统(Record linkage Methods)及制药厂商的上市后药物监察制度(Manufacturer-initiated Postmar-keting Studies)。最近FDA又批准了MEDWatch(医药品安全监察制度)法。有关药品效应特别是药品 After humankind has experienced many phytosanitary events, many countries have successively established various Postmar-keting Surveillance Systems. Their purpose is to ensure the safety and effectiveness of drugs such as yellow Card system, a green card system, the Spontaneous Physician Reporting System advocated by the U.S. Food and Drug Administration (FDA), the Record linkage methods and the Manufacturer-initiated Postmar- keting Studies Recently, the FDA approved the MEDWatch (Medicines Safety Surveillance System) Act. Drug effects, especially medicines