As a special commodity，the drug provides both the benefit and the risk. It cures diseases and may bring adverse drug reaction （ADR）. In the past one hundred years，worldwide adverse drug events happened frequently，which aroused close attention from medical personnel，drug manufacturers and consumers，and made drug regulation authorities aware of the importance of strengthening drug safety monitoring and the necessity to establish ADR relief mechanism.

This paper is to compare and analyze the cases and regulations of adverse drug damage in EU，USA，Japan and Taiwan；and according to the basic theory and future development of tort law，put forward a plan to construct and improve ADR relief mechanism in China；and mainly analyze and propose the relief pattern，legislation system，organization setting，relief object，relief scope，payment qualification，capital source，and payment proportion of ADR injury relief mechanism，providing an effective reference to establish ADR injury relief mechanism in China.